Imagine looking in the mirror each day and seeing your eyes slowly getting bigger and bigger, beginning to bulge out of their sockets and change your face. Not only do you not look like yourself, but the world has become blurry, watery, and disorienting. You struggle to manage daily activities with double vision, severe pain, and discomfort. In many cases, you can no longer drive, work or read, all of which can lead to social isolation and loss of independence. This is the experience of many people living with a thyroid eye disease (TED).

TED is a rare disease in which the immune system attacks the muscle and fat tissue behind the eye causing inflammation, swelling, and eye bulging. Unfortunately, getting a firm diagnosis is sometimes delayed as many people with TED are juggled from doctor to doctor for months, sometimes years.

To complicate things further, the terminology is confusing. Hyperthyroidism, also known as Graves’ disease, is a condition in which patients have an overactive thyroid. TED is most common in people with Graves’ disease.1 In fact, up to 50% of people with Graves’ disease will develop TED.2

 

However, TED can also occur with hypothyroidism, Hashimoto’s disease, and even in those with a normally functioning thyroid gland. While related to those conditions, TED itself requires separate specialists and separate management, monitoring, and treatment plan.

Who is at risk for TED?

  • People with thyroid conditions, like hyperthyroidism, or a family history of thyroid conditions are at an increased risk to develop TED
  • Women are approximately 3x more likely than men to develop TED3, although men are more likely to have a severe form of the disease.4

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  • People who smoke are up to 8x more likely to develop TED5
  • While people can develop TED at any age, the risk of TED increases after 35 years old3

According to a new study, the prevalence of TED is highest among African Americans (23%) and white Americans (18%).3

What are the symptoms of thyroid eye disease?

Since most people who have TED also have hyperthyroidism (Graves’ disease), it is important to understand the difference in symptoms between the two conditions. Hyperthyroidism is an autoimmune disorder where your thyroid becomes overactive and produces more thyroid hormone than the body needs.6 This can result in fast or irregular heartbeat, anxiety, weight loss, insomnia, and heat sensitivity.7

If you have hyperthyroidism or Graves’ disease, you may also notice changes in your eyes, but these are most likely signs of TED. Common symptoms of TED include:5

  • Dry, gritty eyes
  • Redness and swelling of eyes and eyelids
  • Watery and tearing eyes
  • Bulging eyes also called proptosis (protrusion of one or both globes of the eyes)
  • Pain or pressure behind the eyes
  • Sensitivity to light
  • Double vision
  • Retracted eyelids preventing eyelids from closing properly

The primary issue with TED is the inflammation of fat or muscle tissue or both around or within the orbit. Due to this increase in the size of the surrounding tissues, the eye is pushed forward (proptosis), giving the appearance of larger than normal eyes. This can also lead to a “staring” or asymmetrical appearance.2,8

thyroid eye disease closeup photo

TED in a patient with Grave’s Disease – note the bulging eyes and retracted lids.(Photo attribution: Jonathan Trobe, M.D. – University of Michigan Kellogg Eye Center, CC BY 3.0 <httpss://creativecommons.org/licenses/by/3.0>, via Wikimedia Commons)

In advanced cases, the excessive fat and muscle tissue growth behind the eyeball can place a great deal of pressure on the optic nerve. This compression of the nerve can lead to decreased vision, and in rare cases, blindness or vision loss.9

Who should treat TED?

If you have hyperthyroidism or Graves’ disease, your thyroid level is most likely being managed by an endocrinologist who cares for people with thyroid conditions. An endocrinologist may discuss the risks for developing TED. However, at the first sign of any changes in the eyes, it is important to see an experienced TED Specialist, like an oculoplastic surgeon or neuro-ophthalmologist.

A team approach is key. The TED Specialist and endocrinologist should work in partnership to co-manage the TED and underlying thyroid condition.

Related Content:  Dealing with a Rare Eye Disease in the Midst of COVID19

What to expect at the appointment

When you first meet with a TED Specialist, they will perform a series of exams to set a baseline or starting point to measure symptoms against going forward. At your baseline eye exam or the first comprehensive eye exam, your doctor will want to know all about your history with both the thyroid condition as well as when the eye symptoms started. From there, tests will be run to assess many factors, including:

      • Vision
      • Eye muscle movement
      • Eye pressure
      • Eyelid measurements
      • How far the eyes are bulging
      • Impact on optic nerve and retina
      • Peripheral vision

All these tests will determine where you are in the course of the disease and the best path of treatment.

It is important to understand that this process will often require several visits and time to review the analysis of the laboratory and diagnostic testing with both the patient and other care providers involved.

Eye exams at subsequent visits will determine how or if the TED is changing. In between exams, patients will also be asked to carefully track their symptoms, so doctors have the history of any changes or “flare-ups.”

Related Content:  A Little Lump Or Bump On The Eyelid? Beware, It Could Be Skin Cancer!

How is TED treated?

At the onset of TED, people may make lifestyle changes including using non-prescription or prescription lubricating eye drops, wearing sunglasses to help with light sensitivity, and elevating the head of the bed to help relieve pressure and swelling at night.

Treatment options vary based on the severity and duration of the disease. For some patients with minor signs and symptoms of TED, simple lifestyle changes combined with over-the-counter treatments can be impactful.

For others, more sophisticated treatment regimens are required. Some people are prescribed oral steroids to reduce the inflammation, while other people are candidates for surgery, like orbital decompression. There is also an IGF-1R inhibitor therapy that is given through IV infusion.

Time is of the essence

TED is a progressive condition that worsens over time if left untreated. The longer TED goes untreated, the more likely serious eye damage will occur. As soon as any changes in the eyes are noticed, especially if you have Graves’ disease or another thyroid condition, contact a TED Specialist immediately for an appointment.

Caring for TED during COVID-19

While many in-person care facilities are following strict safety guidelines, many doctors are also offering telehealth visits. To participate in a telehealth visit, all patients need is access to a smartphone or computer with a camera. Patients must be in a well-lit environment and hold or position their device still for an optimal experience.

Related stories:
Telehealth Update from ATA President, Dr. Joe Kvedar
Doximity’s New Telehealth Application Makes It Easy to Connect

Despite the virtual circumstances, TED Specialists, such as oculoplastic surgeons, can still conduct a thorough exam simulating an in-office experience. This will include a review of medical history and assessment of visual acuity. By positioning the phone or computer camera close to a person’s eyes, TED Specialists can also assess eyelid measurements and determine an accurate clinical activity score. Not wanting to leave your house is understandable during these times, but it is important to embrace telehealth to ensure consistent management and monitoring of TED.

Finding support and answers

People living with Graves’ disease and TED can find advice, connection, and resources through the following organizations and communities:

Though a rare disease can feel isolating and lonely, you are not alone. Acting quickly and finding the right TED Specialist can help avoid the confusion, misinformation, and delayed care leading up to diagnosis and accelerate the attention you need.

References:


  1. American Thyroid Association. Hyperthyroidism. https://www.thyroid.org/what-is-hyperthyroidism  American Thyroid Association. Hyperthyroidism. Graves’ disease.  https://www.thyroid.org/what-is-graves-disease
  2. Bahn RS. Graves’ Ophthalmopathy. The New England Journal of Medicine. 25 February 2010. httpss://www.nejm.org/doi/full/10.1056/NEJMra0905750. Accessed Mar 2, 2021.
  3. Leslie Hyman, Robert Penne, Danielle Fujino, Deepak Ramesh, Qiang Zhang, Scott Kelly, Flora Lum, Sukhminder Singh; Prevalence and Associated Factors for Thyroid Eye Disease (TED) in the AAO IRIS® Registry.  Ophthalmol. Vis. Sci.2020;61(7):5425.
  4. NORD Thyroid Eye Disease. httpss://rarediseases.org/rare-diseases/thyroid-eye-disease/
  5. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velazquez-Villoria A, Galofre JC. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmology. 2015:1-16.
  6. “Graves’ Disease.” National Institute of Diabetes and Digestive and Kidney Diseases, U.S. Department of Health and Human Services, 1 Sept. 2017, www.niddk.nih.gov/health-information/endocrine-diseases/graves-disease#:~:text=have%20Graves’%20disease%3F-,What%20is%20Graves’%20disease%3F,the%20front%20of%20your%20neck.
  7. Graves Disease by Smith TJ and Hegedus L, NEJM 2016, 375:1552
  8. Charążka B, Suligowska A, Komorowski J, Siejka A. Quality of life in patients with orbitopathy – single center experience. Pol Merkur Lekarski. 2018;44(264):272-275
  9. Prevent Blindness. “Thyroid Eye Disease.” Prevent Blindness, 15 Oct. 2020, preventblindness.org/thyroid-eye-disease/

About two weeks, after I fractured my shoulder a few years ago, I got a phone call from Kaiser Permanente, the health system where I get my care. The woman on the line identified herself as being part of my medical center’s Bone Health team. She said they were calling me because I had sustained a fracture that is suggestive of low bone density. She called it a fragility fracture.

What are fragility fractures?

Fragility fractures are fractures that occur as a result of low energy trauma, for example, falling from a standing height – or no trauma at all [1].

Common fragility fractures include the following:

      • vertebral fractures,
      • humeral head (shoulder) fractures,
      • fractures of the neck of the femur (a.k.a. hip fractures), and
      • Colles fractures of the wrist.

It turned out that Kaiser routinely scans its electronic health records in order to identify patients with these types of fractures so they can bring them in to evaluate their bone health.

How a population health program can help identify “silent” osteoporosis

My first reaction to hearing that I had a fragility fracture was “I am not fragile, I just tripped and fell.” But the Bone Health lady pointed out that people with normal bone health don’t usually fracture their big bones (humerus or femur) when they fall from a standing height. She said I needed to come in for a bone density test and blood tests to measure my vitamin D level (amongst other tests) to determine my risk of fragility fractures.

I was impressed. I am a long time fan of population health programs [2] and have seen health plans and provider groups use them to proactively reach out to people with diabetes, heart failure, and asthma.

At the time, I had never come across a population health program that targeted osteoporosis even though, according to the National Osteoporosis Foundation, 54 million Americans have either osteoporosis or low bone density (osteopenia).[3] Not only that, but 1 in 2 women and 1 in 4 men over the age of 50 will break a bone due to osteoporosis.

Think about that for a minute! That’s an awful lot of people who will experience the pain, suffering, and cost of a bone fracture that perhaps could have been prevented if their low bone density had been detected earlier.

Routine screening for osteoporosis

Hopefully, you won’t wait until you sustain a fragility fracture before being evaluated for your risk of sustaining one. In fact, the USPSTF, a respected organization that reviews guidelines for the prevention of health conditions has concluded with moderate certainty that there is “at least moderate benefit” of screening for osteoporosis in the following individuals [4]:

  • women 65 and older 
  • postmenopausal women younger than 65 years who are at increased risk of osteoporosis is at least moderate

However, they found that current evidence is “insufficient to assess the balance of benefit and harms of screening for osteoporosis in men.” This was primarily based on the lack of evidence for effective treatments of osteoporosis in men.

The USPSTF report states that,

“…it cannot be assumed that [effective treatments for women] will be equally effective in men because the underlying biology of bones may differ in men due to differences in testosterone and estrogen levels.”

Bone mineral density (BMD) tests

 Bone density tests—also called Bone Mineral Density (BMD), DXA, or DEXA (for dual-energy X-ray absorptiometry) test are very important in making the diagnosis of low bone density (osteopenia or osteoporosis).[5]

In addition, they are used to predicting the risk of fractures, particularly when used in conjunction with a bone fracture risk prediction tool, such as the Fracture risk assessment (FRAX) tool (see below). Finally, BMD tests are also used to assess changes in bone density over time and to monitor the effects of treatment.

The BMD machine works by firing X-rays from two different sources through the bones that are being tested towards a detector. The use of two different X-ray sources rather than one allows a more accurate reading of bone density. Mineralized bone blocks a certain amount of the X-rays. The denser the bone is, the fewer X-rays get through to the detector.

There is no special preparation required for the test, although you should let your physician know ahead of time if there is a possibility you are pregnant or if you recently had a barium exam or received an injection of contrast material for a CT or radioisotope scan. Some also recommend that you refrain from taking calcium supplements for 24 hours before the test as they could interfere with the images.[6].

You will be asked to remove any jewelry and change into a hospital gown. Then, you will be positioned on your back on a special examination table. For part of my exam, I had a rectangular-shaped foam pillow placed under my knees and I was asked to remain very still while the machine was actively scanning the bones of my back (the vertebrae) and hip.

If you are unable to lie down so that the spine and hip can be imaged (these provide the best images to predict the risk of osteoporotic fracture) you may instead have a DXA scan of your forearm to establish the diagnosis of osteoporosis.

The total time for the test—scan time plus repositioning time—is about 10 to 15 minutes, depending on which parts of your body are being examined. I was walking back to my car 20 minutes after I checked in for the test—and that included stopping at the lab for some blood tests.

Be sure your doctor is sent the images as well as the summary test results for the best understanding of the findings.

By the way, is important to know that a BMD test is not the same thing as a bone scan that may be used to look for other types of abnormalities in your bones, such as metastases from cancer, infection, or inflammation.

The FRAX tool

At some time before you get your BMD test, you will likely be asked to fill out a FRAX Fracture Risk Assessment Tool.[7] It will look something like this. Information from this test is used to calculate your overall fracture risk as will be explained below.

FRAX Questionnaire screenshot

Please click on the link to get more detailed instructions about how to fill out the form. (Screenshot of FRAX Questionnaire from https://www.sheffield.ac.uk/FRAX/tool.aspx?country=9) 

There are a number of other risk assessment tests available but the FRAX is the most commonly used at the present time.

Understanding the results

The data from the X-ray detector is sent to a computer which calculates a score of the average density of the bone in grams/cm². The computer program compares your score to groups of people of the same ethnicity and gender to calculate two different scores, a T-score and a Z score. When you get the results (and you should ask for a copy of the full report) it will look something like this:

“A bone mineral density (BMD) measurement was performed of the L1-L4 vertebrae and the proximal femur (total femur, neck, trochanteric, and intertrochanteric region) using a Hologic Dual Energy X-ray Absorptiometry Model Discovery C machine.”

  • Have repeat tests done using the same make and model as prior tests

You will want to know the name and model of the machine as it is important in determining your fracture risk. It is also important for your clinician to know this information because the results may vary by the type of machine used. Comparing the results to a prior test done on a different make and model of machine can be problematic.

  • Your values are compared to a reference population

The test result will also describe the measurement values and the comparison group:

“BMD values were determined in gms/cm² and compared to a young normal
reference population (T-score = standard deviations (SDs) below or above the young normal mean), and to an age-matched normal reference population
(Z-score = SDs below or above the age-matched normal mean).”

  • The T and Z scores are both important

The T and Z scores are both important when interpreting the results and deciding if you need treatment. The T-score compares your bone density to that of young normal individuals. Bone density peaks somewhere between 18-35 years old. After that, there is a steady loss of bone that accelerates after menopause and doesn’t slow down again until the age of 70 or so. 

The T-score tells you how much bone you have lost compared to an average peak value of young healthy individuals of the same sex and ethnicity. The Z-score compares your bone density to that of people of the same gender and ethnicity and approximately your same age.

If this score is lower than the reference population, it suggests you are losing bone faster than the average for your peers. This alerts you and your doctor that something other than “normal” bone loss due to aging may be going on.

For example, excessive bone loss may be due to taking certain kinds of drugs, such as glucocorticoids, aromatase inhibitors, or certain types of anti-epilepsy drugs. This type of osteoporosis is referred to as secondary osteoporosis (secondary to a factor other than aging).

  • Understanding caveats about the reference group

Information will be provided that will help you and your doctor understand some details about the comparison group. Mine test results included this statement:

“Reference BMD values for the hip were derived from the NHANES data and for the spine from the Hologic reference data. According to the WHO, criteria osteoporosis is defined by T-scores but you should note that these are only defined for a Caucasian female 65 years or older.”

  • Best practices in BMD testing

According to an excellent review of best practices for Bone Mineral Density testing published in Volume 19 of the 2016 Journal of Clinical Densitometry (yes, there is such a journal)[8]:

“Manufacturers are advised to use National Health and Nutritional Examination Survey III young adult Caucasian female BM data as the reference standard for femoral neck and total proximal femur T-score calculation.”

They can use their own reference data for lumbar spine T-score calculation.

This review makes it clear that, as is true of most things in medicine, the devil is in the details. BMD tests need to be performed properly with well-trained technicians and properly calibrated and maintained machines. The interpretations must be done by people who know what they are doing and understand the critical importance of applying the correct comparisons.

Embarking on treatment for osteoporosis requires that best practices be followed.

“A normal T-score is between 0 and -1.0. Osteopenia is defined as a T-score of -1.1 to -2.4. Osteoporosis is defined as a T-score of less than -2.5.”

Assessment of risk of fragility fractures

The T-score is only one piece of information that is used to estimate the risk of having an osteoporotic fracture over the next 10 years. Although there are several fracture risk predictors available, the one most commonly used is the FRAX tool (shown above). You can find an online FRAX calculator here: www.shef.ac.uk/FRAX

The FRAX tool calculates risk based on age, gender, BMI, and the clinical risk factors reported obtained from a questionnaire filled out at the time of the bone density test (see above).

You can get an estimate of your risk even if you have not yet had your BMD test. But it is more accurate if you are able to include the measured density of your femoral neck—note that you will be asked to include the make of the machine used for your test.

The clinical risk factors considered by FRAX are:

  • a previous fracture
  • a parent who fractured a hip
  • current smoking
  • use of glucocorticoids
  • rheumatoid arthritis
  • a diagnosis of secondary osteoporosis
  • alcohol intake greater than 3 units per day

This is how this information appeared in my report:

“10-year fracture risks were calculated using the World Health Organization FRAX tool based on the age, gender, BMI, clinical risk factors reported by the patient, and the BMD of the femoral neck measured. Clinical risk factors considered by FRAX are: previous fracture, parent fractured hip, current smoking, glucocorticoids, RA, 2nd osteoporosis, and 3 or more alcohol units per day.”

The FRAX score (estimated risk of having an osteoporotic fracture over the next 10 years) is reported as two different risks: The percent risk for any major osteoporotic fracture and the percent risk for a hip fracture.

Who should be considered for treatment?

My report also contained the following language about treatment:

“National Osteoporosis Foundation recommends to consider initiating therapy:

1) postmenopausal women and men age 50 and older with hip or
vertebral fractures, or fragility fractures
2) DEXA BMD T-scores -2.5 or below (after excluding secondary reasons for
osteoporosis)
3) For osteopenic patients: 10-year hip fracture probability < 3% or a 10-year major osteoporosis-related fracture probability < 20% based on the US-adapted WHO absolute fracture risk model FRAX…

…all treatment decisions require clinical judgments and consideration of clinical risk factors that may or may not have been captured in the FRAX model and possible under-or-over estimation of fracture risk by FRAX.”

Missing from the report, but very important is the patient’s preference. Failure to take this into account may be one reason why so many people refuse to initiate treatment, fail to take medications as prescribed, or discontinue treatment that could be beneficial. We will, of course, dive into all of the issues related to the treatment of osteoporosis in a future post.

Want to share your personal journey?

Meanwhile, please leave a comment or contact me at [email protected] if you would like to share your personal journey with osteoporosis. Please do not leave comments asking for medical advice as that is best discussed with your doctor.

References:

  1. van Oostwaard M. Chapter 1: Osteoporosis and the Nature of Fragility Fracture: An Overview, In Fragility Fracture Nursing: Holistic Care and Management of the Orthogeriatric Patient [Internet], 2018, June 16. https://www.ncbi.nlm.nih.gov/books/NBK543829/
  2. Dentler J, Davidson J. 10 Core Components of a Successful Population Health Program, 2015 June 25, Becker’s Hospital Review. https://www.beckershospitalreview.com/hospital-management-administration/10-core-components-of-a-successful-population-health-program.html. Accessed 2/11/21.
  3. National Osteoporosis Foundation. Bone Health Basics: Get the Facts, Accessed 2/11/21. https://www.nof.org/preventing-fractures/general-facts/
  4. USPSTF Final Recommendation Statement. Osteoporosis to Prevent Fractures: Screening, 6/26/18. https://www.uspreventiveservicestaskforce.org/uspstf/document/RecommendationStatementFinal/osteoporosis-screening
  5. Lewiecki E. Prevention of Osteoporosis, UpToDate (Official reprint) Wolters Kluwer. Accessed 2/11/21. https://www.uptodate.com/contents/prevention-of-osteoporosis/print
  6. Finkelstein J, Yu E. What Does Bone Density Testing Do and Why is It Important? UpToDate (Official Reprint) Wolters Kluwer, Accessed 2/11/21. 
  7. FRAX The Fracture Risk Assessment Tool calculator for the United States https://www.sheffield.ac.uk/FRAX/tool.aspx?country=9
  8. Lewiecki E, Binkley N, Morgan S, et al. Best Practices for Dual-Energy X-ray Absorptiometry Measurement and Reporting: International Society for Clinical Densitometry Guidance, J. Clin Densitom. 2016 April-June. https://pubmed.ncbi.nlm.nih.gov/27020004/

First published on Aug. 3, 2016

Early testing in healthcare has been a hot topic in recent months. For both infectious diseases and countless other health conditions. Timely testing is critical to faster diagnosis, prompter treatment, and, ultimately, better outcomes in many medical conditions, including osteoporosis.

As a physician who has the opportunity to care for patients living with this common, yet serious, disease, I understand first-hand the importance of early testing for osteoporosis. Individuals can have the condition for a long time and not even know it. 

Osteoporosis is a silent disease

Osteoporosis is a silent disease. Patients often have no signs or symptoms until a fracture occurs.

Risk factors for osteoporosis include

  • age,
  • family history,
  • being a woman.

Estrogen significantly affects the rate of bone loss. This is why osteoporosis is most common in postmenopausal women.

In the first 5-7 years after menopause, bone breakdown outpaces bone formation and bone loss often accelerates. Up to 20% of bone mass can be lost in a few years.[i]

Moreover, nearly 1 in 2 women over the age of 50 will experience a fragility, or low-impact, fracture.[ii] Unfortunately, there is still a disconnect that these fractures, such as those in the wrist or ankle, could be a warning sign for the disease. As a result, many patients go undiagnosed and untreated.

That’s why if your patients are women over 50, it’s important to prioritize bone health. Early identification and treatment of low bone density is the most effective approach in order to help patients avoid future painful fractures.

Testing for osteoporosis

A dual-energy X-ray absorptiometry scan, commonly referred to as a DXA scan, is a widely available, reliable bone density test. The test requires no special preparation and typically takes only 5 to 10 minutes.

For the results of the test, patients receive a T-score, which shows how much higher or lower their bone density is than that of a healthy young person, when bones are at their strongest. In general, the lower the bone density, the greater the potential risk of fracture.

Many women wait to obtain a bone density test until they are 65. However, if patients have clinical risk factors for bone loss or have experienced fractures, earlier testing is important.

Many women enter menopause with low bone mass already. Further, for some subsets of women, there is a risk for rapid bone loss of 10-20% over just five years.[iii]

For that reason, in my practice, I typically recommend a bone density test for anyone 50 and older with clinical risk factors. This is especially true for those who have already experienced a fracture.[iv]

The results of a DXA scan, combined with other risk factors including, but not limited to,

  • family history,
  • fracture history,
  • smoking,
  • excess alcohol,

will help assess future fracture risk and determine the need for potential treatment.

Understanding osteoporosis treatment options

Lifestyle changes, such as calcium, vitamin D, and fall protection, may be effective for some patients. However, when fracture risk is high, medications are needed.

Fortunately, there is a strong arsenal of treatment options. But, it is important to remember that what’s right for one person may not be right for another.

Prescription osteoporosis treatments come in several forms, including

  • pills,
  • injections,
  • infusions.

They can be broken into two categories: antiresorptive and anabolic agents.

  • Antiresorptive treatments

Antiresorptive treatments include the following:

      • bisphosphonates,
      • RANKL inhibitors,
      • calcitonin,
      • hormone therapies.

These types of medications help slow down the process of bone loss in order to preserve bone strength to reduce the risk of fracture.

  • Anabolic treatments

Anabolic treatments include drugs such as PTH analogs and sclerostin inhibitors that do more than just maintain the bone that you already have. They help build new bone to reduce the risk of fracture.

Since studies have shown that postmenopausal women who have had a low-impact fracture are 6 times more likely to have another fracture within 1 year[v]. These bone builders, therefore, are an important option to help reduce the risk of fracture or subsequent fractures in this high-risk population.

Patients must play a role in their treatment decisions

It’s critical that patients play a role in their treatment decisions. This means that they must be fully educated on all their options, including the benefit-risk profile.

As a first step, I encourage my patients to visit the websites of the companies that make the treatments. And, I advise them to look at the information in an objective way. Patients should also always talk to their doctor to make sure they are balancing the risk and the reward.

As adults age, the impact of fractures can become more serious, increasing the risk of loss of independence and even dying prematurely. In fact, hip fractures have a 20% 1-year mortality in women (higher in men). And they cause 1 out of 5 patients to need care in a nursing home. They are the most serious type of fracture caused by osteoporosis and 75% of all hip fractures happen in women.[vi],[vii] Another recent study found that older adults who suffer a fragility hip fracture have an increased risk for death that lasts for more than 10 years after the fracture.[viii]

Related content: What Happened When I Fell and Broke My Shoulder

All of these statistics reiterate the importance of being an empowered patient if they’ve been diagnosed with postmenopausal osteoporosis. They need to talk with their doctor about their bone health to fully understand their options. And they must choose a treatment where the benefits outweigh the risks. 

Empowerment and Collaboration

The disconnect between osteoporosis and related fractures and subsequent treatment gap is alarming. However, there is a tremendous opportunity before us. By empowering more women to obtain bone density tests before a fracture occurs, even when they otherwise have no symptoms, we can ensure they take the necessary steps to protect bones by seeking treatment earlier.

I encourage my fellow physicians to engage in open dialogue with patients. Talking will help them fully understand all of the available postmenopausal osteoporosis treatment options. This means including both antiresorptives, which slow down bone loss, and anabolic medications that are designed to help boost the natural process that builds new bone. 

With a concerted effort and greater collaboration between patients, primary care providers and specialists who more regularly treat postmenopausal women, such as rheumatologists and endocrinologists, we can help many more patients make effective treatment decisions earlier and reduce their fracture risk.

References


[i] National Osteoporosis Foundation – What Women Need to Know. Available at: https://www.nof.org/preventing-fractures/general-facts/what-women-need-to-know/. Accessed 05/26/2020.

[ii] National Osteoporosis Foundation. What is osteoporosis and what causes it? https://www.nof.org/patients/what-is-osteoporosis/. Accessed 05/21/2020.

[iii] Finkelstein J., et al. Bone mineral density changes during the menopause transition in a multiethnic cohort of women. J Clin Endocrinol Metab. 2008 Mar; 93(3): 861–868. Free access available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2266953/. Accessed 05/21/2020.

[iv] National Osteoporosis Foundation. Bone Density Exam/Testing. https://www.nof.org/patients/diagnosis-information/bone-density-examtesting/. Accessed 06/01/2020.

[v] Simonelli C, et al. Evaluation and Management of Osteoporosis Following Hospitalization for Low-Impact Fracture. J Gen Intern Med. 2003 Jan;18(1)17-22. Free access available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1494813/. Accessed 05/21/2020.

[vi] Leibson CL, et.al. Mortality, disability, and nursing home use for persons with and without hip fracture: a population-based study. J Am Geriatr Soc. 2002;50(10):1644‐1650. Accessed 06/01/2020.

[vii] Hyassat, D., et.al. Prevalence and risk factors of osteoporosis among Jordanian postmenopausal women attending the National Center for Diabetes, Endocrinology and Genetics in Jordan. BioRes Open Access. 2017; 6(1): 85–93. Free access available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5515108. Accessed 06/01/2020.

[viii] Tran T., et. al. Persistence of excess mortality following individual nonhip fractures: a relative survival analysis. J Clinical Endo Metabolism. 2018 Sep; 103(9): 3205–3214. Free access available at: https://academic.oup.com/jcem/article/103/9/3Bone 205/4996518. Accessed 05/21/2020.

Who knew that a trip to the airport, one that I had done many times, would end up so badly. Here is what happened in August 2016 when I fell and broke my shoulder.

I was in a hurry to get to the gate for my flight to Tuscon. I was flying to an important meeting where I was going to have the chance to interview a former Surgeon General. The traffic from Marin to SFO was obnoxious, and the TSA line very slow.

I was wearing a heavy backpack. Optimistic about getting some work done on the plane, I had filled it with medical journals and my laptop. I was also pulling my wheelie.

I was walking my usual fast pace when the ball of my left foot struck the floor first—it had been happening a lot lately—and I stumbled. As I tried to get my balance, the backpack slid up towards my head and propelled me forward and down—hard.

I took the brunt of the fall on my right shoulder, but the worst pain was in the middle of my upper arm. I couldn’t use it to help me get up off the floor.

After the fall

A kind passerby got down on the floor next to me and said, with confidence, “I am certified in first aid. Can I help?” Grateful, I directed her to take my left arm and gently pull me into a sitting position.

By now, I am the center of attention, surrounded by airport police, passengers, and a United Airlines representative who told me, in no uncertain terms, that I would not be getting on my flight to Tucson. This was after I asked him to please take me to the gate in a wheelchair. Although he kindly booked me on a later flight, just in case the injury turned out to be something minor, he had already called for an ambulance.

So that was how I ended up as a patient in the ER I used to work in. The emergency physician on duty was one of the few people I still knew at Kaiser South San Francisco.

He sewed up a small laceration in my right eyebrow and arranged for the x-ray. The radiologist, an old friend from my running days, gave me the bad news. I had a displaced fracture of the greater tuberosity of the humerus plus a non-displaced surgical neck fracture.

I was definitely not going to Tucson.

broke my shoulder

My Xrays showed a proximal humerus 2-part fracture. I am definitely not going to Tucson. (Photo source: author)

Why a fall is not just a fall

There are so many interesting and important questions raised by my fall that I want to share with you because I learned that a fall is not just a fall and a broken shoulder is not just a broken shoulder. Bear with me as I take you through some of my thinking.

First of all, there’s the question: Why did I fall? The folks at the airport and the clinicians in the ER asked all the right questions to make sure it wasn’t something that needed an urgent evaluation. Did I have chest pain, dizziness, palpitations? No. Did I trip on something—an uneven tile or an object on the floor? No.

I am very clear about why I fell. I tripped over my own left foot. Once I explained that people lost interest in why I fell and concentrated on the result of my fall—the proximal humeral fractures. But, we will come back to the why later on because it is one of the most important questions that can be asked about a fall.

Managing the pain of my broken shoulder

The next question was, what did I need for pain? I opted for 1 gram of IV acetaminophen. It worked like a charm and left my head clear, so I could sort out the other issues.

One of the most urgent was notifying my client that I would not be at their meeting in Tucson the next morning. I also had to figure out the best way to get home without having my husband schlepp an hour to retrieve me.

An obviously important issue to address: What’s the treatment? After all, you can’t put a shoulder in a cast.

I was given a sling and a follow-up appointment in Orthopedics for a week hence. I opted for NSAIDs for pain because I don’t like nausea and foggy head that accompany opioids. It turns out that was all I needed.

Getting discharged from the ER was smooth and easy

The discharge from the ER was amazing. My friend, the ER doc, gave me a white and blue pocket folder filled with all the information I would need until I could see the bone doc. In it were several sheets of paper that described upper extremity fractures. It also outlined the home care and follow-up instructions and explained when to seek urgent medical advice.

I also found instructions on how to take the pain medication together with a note telling me that I could pick up my prescription at any pharmacy. It was already entered into the system-wide EHR. (Eat your hearts out, all you people getting care outside of an integrated delivery system.)

I tucked the paper copies of my X-rays in the folder and paid my $5 (no kidding) copay. And then I said my thank yous to the staff who had treated me so kindly and professionally.

ADD_THIS_TEXT
 

I took a Lyft home, whining to the driver about how I was missing a great meeting in Tucson. Even more important, I complained, I was going to miss the upcoming family trip rafting the Middle Fork of the Salmon that I had been looking forward to for months.

Follow-up for my broken shoulder

broken shoulder

My bruised arm looked like something from another world. Who knew a trip and fall could end up looking like this?

I got plugged into Kaiser’s orthopedic department and had regular x-rays to ensure healing was going ok. Of course, I spent hours on PubMed and other sites on the internet trying to determine what was the best treatment for my particular fractures.

My fellow internists won’t be surprised to hear that the Orthopedic literature is a mess. Most of the papers I read insisted surgery was the treatment of choice, but I was being treated conservatively with a sling and physical therapy (PT).

So, I made an appointment with the shoulder specialist at my Kaiser medical center to review the literature—yes, you can do that. He described several studies. One was from the UK that I had already read. The researchers found that outcomes were the same for people treated with surgery and those treated with a sling. 

This was the case even if there was displacement of the greater tuberosity like I had. Further, he pointed out, the top of my humeral head had a good shape. Also, there was plenty of room between it and the acromion, so impingement syndrome was unlikely.

I was lucky. Even before I started PT, my shoulder range of motion started to improve. With PT, I went to 80% of the way to normal shoulder function within 2-3 months. I continued doing my PT exercises at home for about a year and a half. My functional range of motion is now about 95 to 100% normal.

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Many questions about my fall and fracture remain

I have only scratched the surface of issues related to falls and fractures in this post. Many questions remain:

  1. The humerus is a big bone. Why did mine break after a simple fall from a standing position? Had my long-standing osteopenia progressed to osteoporosis? If I have osteoporosis, what is the best treatment? And what are its side effects?
  2. Why did I trip? Did I have a foot drop or some other gait abnormality? Or was it just a problem with my shoes, my clumsiness, or my inattention? Equally important, what can I do to prevent falling in the future—a huge source of morbidity for women (and men) “of a certain age.”
  3. How can I get back the full and normal function of my right arm? Believe it or not, I was so good at holding it still by my side that I had to consciously remember to use it once it was freed from the sling.
  4. How do I overcome my newly acquired fear of falling and mental images of falling when I go up and down stairs or walk with my big old black lab? Is this a form of PTSD? What’s the best way to renormalize my disturbed sleep?

It is important to explore all of these aspects of falls and fractures because I think all too often clinicians, friends, and family members,—and even patients—think that a fall is just a fall. But in many cases, as I have learned, a fall may be so much more.

If you would like to add to this list of issues to explore, please pass them along either as a comment on this post or as an email to [email protected]

Learning and supporting each other

I am also hoping to hear more from readers about their experiences with osteoporotic fractures. I am pleased that the comment section of this post has become an important resource for people (mostly women) who have fallen and broken their shoulders.

In addition to telling their fracture stories, women have been offering answers to the following questions:

  • Did anyone ask if you had low bone density (osteopenia or osteoporosis)? Were you offered screening for the condition?
  • Were you evaluated for underlying or contributing reasons for the fall (e.g., balance problems, vision problems, safety issues in the home)?
  • Did you experience significant emotional sequelae (e.g., fear of falling, depression, insomnia) after the fall/fracture? Did any of your health professionals ask about or offer help with these symptoms? 

Please join in by leaving your responses in the comment section below. Or, send me an email via [email protected]

Related content:
Do You Know Your Risk of Fragility Fractures?
Why are So Many People Taking Their Chances with Osteoporosis?
Drugs, Falls, and Fractures: Missed Opportunities in Osteoporosis
Early Testing for Osteoporosis Gives Voice to a Silent Disease


Originally published in August 2016, it was updated by the author for republication today.

Polycystic ovary syndrome (PCOS) is common but, unfortunately, it often goes undiagnosed. According to the PCOS Awareness Association, 9-18% of women worldwide have the condition. However, an estimated 50 percent of the 10 million women living with PCOS are undiagnosed. One-third of women who receive a diagnosis report that it was delayed by ~ 2 years.

This article takes a deep dive into the condition as detailed in the table of contents. It also includes a discussion of some new and exciting PCOS research about the role of genetics and the gut microbiome that could, in time, lead to better diagnosis and improved treatment,

What is PCOS?  

PCOS is a common endocrine condition. That means it is related to hormones. It primarily affects women of reproductive age, most often between the ages of 18 to 35. It has both physical and emotional effects on the woman with the condition.  

PCOS is the leading cause of infertility that is based on ovulation dysfunction. The exact cause of the disorder is unknown but recent research suggests links to genetics (it runs in families). It is also linked to the status of the gut microbiome.

Women with PCOS often have higher than normal levels of male hormones (androgens). Elevated androgens interfere with ovulation (release of eggs from the follicles).

Chronic anovulation may result in cystic follicles in the ovaries – thus, the name polycystic ovary syndrome. The assumption is that the cystic follicles develop because the eggs do not mature normally and are not expelled at the time of ovulation.

What are the consequences of PCOS?

Not only does PCOS impact infertility but women with the diagnosis are at greater risk for other serious health conditions, such as:

  • Metabolic syndrome  which is characterized by the following:
    • central obesity
    • high blood pressure
    • high blood sugar 
    • excess body fat around the waist 
    • abnormal blood lipids
  • Diabetes
  • Cardiovascular disease
  • Depression
  • Anxiety

Early diagnosis is important for women who want to have children. It is also important to help prevent or control these other, often serious, conditions.

There is currently no cure for PCOS but there are treatments to improve both quality of life and the potential for pregnancy.

What are the symptoms of PCOS?

PCOS is characterized by a variety of symptoms, including:

  • irregular or absent menstrual periods
  • infertility
  • pelvic pain
  • weight gain/obesity
  • excessive growth of central body hair (hirsutism)
  • acne
  • anxiety and depression
  • fatigue
  • sleep apnea
  • headaches

This may be one explanation for why the condition is often challenging to diagnose.

Related content: Women’s Health: The Pressing Need to Think Holistically

How is PCOS diagnosed?

There is no test to definitely diagnose PCOS. The absence of a targeted diagnostic test likely contributes to delay in diagnosis.

If PCOS is suspected, your doctor is most likely to begin by asking about your medical history, including menstrual periods and changes in weight. He/she will also do a physical exam, including a pelvic exam and obtain blood work.

  • General physical exam

Your doctor will measure your blood pressure, weight/body mass index, and waist size. She will also look for excess hair growth on your face, chest or back, and acne, or skin discoloration. She may also look for hair loss or signs of other health conditions such as an enlarged thyroid gland or insulin resistance.

  • Pelvic exam

You will also have a pelvic exam in order to identify any growths, masses or other abnormalities in your reproductive organs.

  • Transvaginal ultrasound

A transvaginal ultrasound exam will be performed to see if your ovaries are swollen, enlarged or if there are cysts. The thickness of the uterine wall will also be examined.

The test involves a transponder – a wand-like device – that uses sound waves and produces images on a computer screen.

  • Blood tests

Blood tests will be obtained to look at hormone levels. There may be other reasons for having excess androgens or an abnormal period, for example, a thyroid problem. Blood tests may also be used to look at glucose intolerance and high cholesterol (a sign of metabolic syndrome).

Diagnostic criteria for PCOS

A diagnosis of PCOS is considered when at least 2 out the 3 following findings are present:

  • Increased numbers of cysts (antral follicles) in the ovaries (polycystic ovaries) detected by ultrasound (more than a total of 24 antral follicles in both ovaries)
  • Elevated levels of testosterone or clinical findings, such as central obesity (‘belly fat”), excess body hair (hirsutism) or acne
  • Irregular or no menstrual periods 

Once you receive a diagnosis of PCOS your doctor may suggest, based on your clinical situation, additional screening tests for depression and anxiety and for obstructive sleep apnea. There will also be periodic tests to check your blood pressure, glucose tolerance, and cholesterol and triglyceride levels.

The additional test results will be used to determine your risk for developing hypertension, diabetes and heart disease and to prevent or control these conditions.  

What treatment is available for PCOS if I want to get pregnant?

While there is no cure for PCOS, lifestyle changes, medications, and other types of treatments can improve the condition and help to avoid the development of associated conditions, such as metabolic syndrome. 

  • Lifestyle changes

According to Dara Godfrey, R.D., registered dietician and nutritionist for Reproductive Medicine Associates of New York, a healthy diet and exercise are highly recommended and can make a difference. You can help treat PCOS symptoms, improve fertility, and prevent the development of associated conditions by losing weight if you are overweight or obese.

Losing even a modest amount, just 5% of body weight, can make menstrual cycles more regular, restore ovulation and thus, improve fertility. Godfrey advises patients to exercise daily, limit carbs, avoid added sugars, and eat more plant-based foods.

  • Additional options to improve the chance of getting pregnant  

    • Medication

If other causes for infertility are ruled out for both partners, your doctor may prescribe a fertility drug such as clomiphene (Clomid)  or Letrozole, and sometimes metformin, to help you ovulate.

If medication doesn’t work, IVF may be an option. IVF has both higher rates of pregnancy and a smaller risk of multiple births than a fertility drug alone.

  • Egg Freezing

With early diagnosis, women can consider the option of freezing their eggs if fertility is compromised.

  • Surgery

A surgical procedure may be considered but usually only if the other options fail.

One type of surgery involves using a laser or electrosurgery for ovarian drilling to create several holes in the ovaries. This is done to damage a small amount of ovarian tissue.

This small injury results in a change in hormone levels that leads to ovulation in about 2/3 of women so treated. About half of these, or 1/3 of all women treated, will get pregnant. About 1/3 will continue to have regular cycles while the others will return to having irregular cycles.

As with any condition of this type, a full discussion with your doctor can help with selecting the treatment that may be most effective for your individual case.

Treatments for other findings related to androgen excess?

Your doctor can help you address the additional symptoms below. Treatments may vary based on your unique situation including whether and how other symptoms are being treated.

For example, birth control pills are often used to regulate menstrual bleeding and are also the main medical treatment for hirsutism. However, birth control pills that contain only progesterone can sometimes make acne worse while those with both progesterone and estrogen can improve acne. And, for some, birth control pills can make depression worse.

Is there any new research on PCOS?

Research has uncovered new information about PCOS and the diversity of gut bacteria and genetic differences. Additionally, the results of a large survey of PCOS patients may also help improve education and support of the condition. Let’s examine each of these more closely:

  • The role of the gut microbiome in PCOS:

A 2018 study published in The Journal of Clinical Endocrinology & Metabolism found that women with PCOS have less diverse populations of gut bacteria compared to women without the disorder. The researchers compared 73 women diagnosed with PCOS to 48 who did not have the disorder and 42 women who had polycystic ovaries but not the other features of PCOS.

They found that women with PCOS had the least diverse gut bacteria whereas those without PCOS had the most diverse. Women with polycystic ovaries but not the other PCOS features tended to have more diverse gut bacteria than women with PCOS, but less diversity than women without the condition.

The lead author of the study, Varykina Thackray, Ph.D. Associate Professor, UC San Diego School of Medicine, Department of Reproductive Medicine spoke to the Endocrine Society, the professional group and publisher of The Journal of Clinical Endocrinology & Metabolism, noting the research “suggests testosterone and other androgen hormones may help shape the gut microbiome, and these changes may influence the development of PCOS and the impact it has on a women’s quality of life.”

Additional research is needed:

According to Thackray, additional research is needed to determine whether specific gut bacterial species contribute to the development of PCOS and whether the microbiome offers a potential guide for treatment. 

“If testosterone drives the microbial composition of the gut, a compelling next step would be to determine if treatment of PCOS with testosterone blockers or oral contraceptives results in the recovery of the gut microbiome. 

It would also be important to figure out whether the gut microbiome of women diagnosed with PCOS using the criteria of polycystic ovaries and irregular or no menstrual periods is distinct from the gut microbiome of women diagnosed with the other subtypes of PCOS that require elevated testosterone.”

Follow-up study: co-housing PCOS and non-PCOS mice

A follow-up study by Thackray and her team presented at the annual meeting of The Endocrine Society reported intriguing results that show that “altering the gut microbiome via prebiotic or probiotic therapies may be a potential treatment option for PCOS.”

The researchers co-housed PCOS mice with non-PCOS, placebo-treated mice. This exposed the mice to each other’s gut microbiome leading to changes in the gut bacteria. The study found that the PCOS mice showed the following improvements, amongst other changes:

      • developed regular periods and ovulation
      • lower testosterone levels
      • lower insulin levels 
      • less insulin resistance
      • decreased weight

As with the earlier study, Thackray concluded in remarks to The Endocrine Society that “additional research is needed to understand how specific gut bacteria contribute to PCOS and whether the gut microbiome offers potential avenues for treating the condition.” 

The latest study: obese teens have more unhealthy gut bacteria

A study published in the January 23, 2020 issue of the Journal of Clinical Endocrinology & Metabolism found that obese teens with PCOS have more “unhealthy” gut bacteria compared to obese teens without PCOS. 

According to one author, Melanie Cree Green, M.D., Ph.D., of Children’s Hospital Colorado in Aurora, Colorado:

“The unhealthy bacteria related to higher testosterone concentrations and markers of metabolic complications.”

Lower bacterial diversity was strongly associated with higher testosterone concentrations. However, further work is needed to determine if microbiota changes are reflective of, or influencing, hormonal metabolism.

  • Genetic markers for PCOS

A 2019 study published in The Journal of Clinical Endocrinology & Metabolism found that a rare genetic variation helps “drive testosterone production in the ovaries.” 

According to lead author Andrea Dunaif, M.D, Chief of the Endocrinology, Diabetes and Bone Disease Division at the Icahn School of Medicine at Mount Sinai, this genetic variation could serve a marker for early PCOS detection. The same study also showed, for the first time, genetic evidence of “a causal link between PCOS and depression.”

She added “Because physicians don’t know what causes PCOS, they will treat your symptoms. Through genetics, we’re starting to understand the condition and may have specific therapies in the not-so-distant future.”

  • Research: patient-centered care 

Beyond new clinical research to advance early diagnosis and treatment, significant progress is needed to improve PCOS patient-centered care. This includes better education and more support based on patient surveys.

    • Delays in diagnosis

The largest study to date to examine the length of time for PCOS diagnosis discovered “major gaps” in education and support. The 2017 study was conducted by the Perelman School of Medicine at the University of Pennsylvania and published in the Journal of Clinical Endocrinology & Metabolism.

The study surveyed 1,385 women from 48 different countries diagnosed with PCOS to learn more about their diagnosis experience and what information they received about the condition. Here are some of their findings:

      • More than one-third (33.6 percent) of women reported it took more than two years before receiving a diagnosis
      • Nearly half (47.1 percent) saw three or more health professionals before receiving a diagnosis
      • Only 15.6 percent of women said they were satisfied with the information they received

It should come as no surprise that “studies have shown that the longer it takes for the condition to be diagnosed, the greater the patient dissatisfaction,” according to senior author Anuja Dokras, MD, Ph.D., a Professor of Obstetrics and Gynecology and director of the Penn Polycystic Ovary Syndrome Program.

She adds “These new results are concerning for both women who are, or may be, affected by PCOS, and health care providers.”

    • Better support for women with PCOS

In the same study, women surveyed were also asked how to best support those with PCOS:

      • More than 90 percent said providing broadly available educational materials would be helpful
      • 70 percent expressed an interest in support and presentations at patient workshops

Study authors believe “greater community and clinician awareness about the full range of PCOS features is needed internationally to enable early diagnosis.” 

Dokras observed that the women with PCOS were most concerned about their trouble losing weight, irregular menstrual cycles, and infertility. She said:

“Health care providers have an obligation to provide these patients with better support and information at the time of diagnosis to help them understand and manage their condition.”

    • Earlier diagnosis is important to women with PCOS

This study documented struggles and delays in PCOS diagnosis and reveals a significant missed opportunity to improve treatment and quality of life for these patients. Study authors suggest an earlier diagnosis will allow providers to more proactively intervene and treat symptoms such as obesity, acne, excess body hair, anxiety, and depression more effectively.

For other PCOS factors, the timing of diagnosis and treatment is critical, particularly for those who want to have children and women at the highest risk for serious conditions including diabetes, hypertension, and heart disease.

To improve, the study authors call for:

      • Development of international evidence-based guidelines
      • Co-designed consumer and health professional resources
      • International dissemination to improve diagnosis experience, education, management, and health outcomes

For the past few years, health care providers and patients have heralded the age of “patient empowerment.” The value of knowing more improves self-care management and more effective shared medical decision making. This is certainly true today for those dealing with infertility. 

Related Content:  5 Things Not to Do When Delivering Bad News to Patients

The bottom line

There is vast room for improvement for PCOS, a condition that affects so many women across the globe and impacts fertility. It can have a devastating effect on health status and quality of life. The good news is that there is promising news from recent clinical research that may aid diagnosis, treatment, and patient-centered care.

Still, what women are currently experiencing, particularly as it relates to diagnosis, is simply unacceptable. We need to do better.

A number of organizations are trying to fill in some of the gaps by offering support groups and up-to-date information while advocating for progress. You can start by checking out the FAQ index and PCOS glossary from the PCOS Awareness Association. Additional support and resources are available from The PCOS Challenge, the National PCOS Association. Good, evidence-based information can also be found at www.reproductivefacts.org.

Other stories in Women’s Health: Health Conditions That Can Lead to a Hysterectomy

Watch this space. It can only get better.

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I was offered my choice of bisphosphonates after breaking my shoulder and ending up with a diagnosis of osteoporosis. I initially opted for Reclast, a drug that only requires one dose a year albeit by IV infusion. I made an appointment to get the drug several weeks later. I wanted to have time to research my options.

After reading as much as I could during that time, I made an appointment with my bone health specialist to discuss the treatment. We spent 45 minutes discussing the osteoporosis literature. Despite being a physician, trained in endocrinology, and now pretty up-to-date on the treatment, I just could not bring myself to tell her that, yes, I would take the drug in any of its formulations. Why is that?

I am not anti-medication; I take a ton of them for various conditions that I blame on my mother’s side of the family as well as certain of my less than stellar habits. I also understand the seriousness of the disorder, not only because my broken bone hurt like hell, but also because I am aware of the dismal outcomes of people who fall and break their hips or fracture their vertebrae. This is definitely a serious condition.

I also know that I am probably not going to build stronger bones without some type of treatment. With the exception of taking calcium supplements, I was already doing all of the recommended lifestyle interventions. I started running in my late 20’s and have continued to do weight-bearing exercises until this day. I eat a healthy diet and I have never had to take any of the drugs known to weaken bones. I even took a selective estrogen receptor modifier (SERM) for more than 20 years. Although I was diagnosed with Vitamin D deficiency a few years ago, I have had D3 levels in the normal range since I started taking supplements.

So, my choice was taking bisphosphonates—the current drug of choice for osteoporosis—or taking my chances that I won’t get another fracture.

Related Content:  Early Testing for Osteoporosis Gives a Voice to a Silent Disease

A crisis in the treatment of osteoporosis

An editorial (August 2016) in the Journal of Bone and Mineral Research, titled “A Crises in the Treatment of Osteoporosis,” makes it clear that I am not alone in my ambivalence about the current treatment of choice. A study that looked at bisphosphonate use in 22,598 hip fracture patients to prevent additional fractures, found that the use of the drug decreased from a measly 15% in 2004 to an “abysmal” 3% by 2013.

The authors of the editorial are Sundeep Khosla, MD from Mayo Clinic and Elizabeth Shane from Columbia University (the former with no conflicts of interest, the latter with a history of research support from Lilly, Amgen, and Merck, the manufacturer of the most commonly prescribed bisphosphonate, Fosamax). They note that although bisphosphonates are the “most widely-used drugs today to prevent and treat osteoporosis,” serious side effects, such as osteonecrosis of the jaw, atrial fibrillation, and atypical femur fractures, have scared people away from these drugs even though they are rare.

Citing an analysis of three randomized clinical trials of bisphosphonates, the authors point out that it is the relative risk, not absolute risk that needs to be discussed with patients fearful of taking these drugs. Here is what they mean:

  • About 100 fractures (vertebral and nonvertebral) are prevented if 1000 women with osteoporosis are treated with a bisphosphonate for 3 years. The number needed to treat (NNT) is 10. The number needed to treat for statins is 56. The smaller the number, the better. An NNT of 1 means everyone improves with the treatment and no one in the control group gets better.
  • For the 100 fractures prevented by taking bisphosphonates, 0.02 to 1.25 atypical femur fractures occur. The number needed to harm is 800 to 43,300.

To translate this, there is a very good chance patients will benefit from bisphosphonates and a very small chance that they will be harmed.

In addition to fear of the horrific, albeit rare side effects, there is the difficulty taking the drug in oral form. You have to take it on an empty stomach and not lay down or eat for at least a half hour. If you opt for the IV form, you have to get yourself to an infusion clinic to receive it, which is time-consuming and costly.

Stoking the fear

Fear is stoked in no small measure by the large number of stories on the Internet. Google “bisphosphonates” and you will almost certainly come across the prolific writings of Vivian Goldschmidt, Founder of The Save Institute (short for “Save Our Bones”). Her website proclaims the Institute provides

“…natural evidence-based solutions [for osteoporosis] that anyone can understand and implement”

The website is loaded with both testimonials, like this one,

“Been on your program one and a half years. my dexa was -4.9 a year ago, went back this year my dexa was -0.7. I am so happy with the exercises and the supplements.”

and “alerts” about bisphosphonates, like these:

  • ALERT: Bisphosphonates Double the Risk Of Esophageal Cancer

  • ALERT: Bisphosphonates Almost Double The Risk Of Vision Loss

  • Alert! Never-Published Study Uncovers How And Why Bisphosphonates Cause Atypical Fractures

The alerts are accompanied by comments from readers that describe horrible side effects all brought on by taking bisphosphonates.

I don’t mean to pick on Save our Bones but the internet is flooded with bad bisphosphonate stories.

What’s a patient to do?

I was lucky. I have access to a bone health expert and a PCP, both of whom have been willing to talk me through my bisphosphonate fears. Interestingly, what finally pushed me over to the “take them, you fool” side of the equation was a photo our Social Media Manager Steffie Harner found to accompany my own story on drugs and osteoporosis.

Elderly woman falling down (1500 x 1147) Adobe Stock

The woman in this photo conjured up visions of my much loved strong but shrinking, blue-haired granny. Although she didn’t fall and break her hip, she clearly had osteoporosis at the end of her life. This could have been her…or, it might be me.

Although I am an endocrinology-trained physician who has read the recent osteoporosis literature, it took a photo to really bring home to me what the consequences could be for me if I didn’t take the drug that my doctors and most osteoporosis experts recommend.

Patient decision-making in the era of empowered patients is complex and poorly understood. In the old days when doctors were gods, they (we) said it and you did it (or not).

However, in the internet era, the inputs into the decision-making process have grown exponentially. There is so much to see, read, and listen to. So, who would have guessed that my own informed decision would be so heavily influenced by my emotional response to a photo? This should give pause to all of us who pontificate about patient behavior.


10/1/16 Postscript: I took my first alendronate (generic Fosamax) pill almost a week ago and outside of the inconvenience of having to plan my morning around the dosing, I didn’t feel a thing. Everything’s good…so far.

2/11/2021 Postscript: So everything did not turn out to be fine after all. I took Fosamax for several months when I started noticing something was wrong with my vision. I had more floaters than usual and something just didn’t feel right. It took me another couple of months to get myself in to see an ophthalmologist.  To my horror, he found on OCT examination that I had huge lesions in both of my eyes. He immediately suspected a rare condition called chorioretinitis.

I was referred to a specialist in that type of disease who was part of my health plan. The treatment was high dose Prednisone (definitely not good for my osteoporosis) and Cellcept – an immunosuppressant that came with many pages of warnings. Despite exhortations from my PCP, I discontinued the Fosamax deciding that a broken bone was infinitely better than going blind.

I got a second opinion from a Stanford doctor who is renowned for his work on this type of problem. Together we decided that my eye disease could have been related to taking Fosamax. This was primarily because my eyes were fine on OCT before I started taking the drug and scarred afterward with all of the known causes of the condition being ruled out by extensive testing. Eventually, I was written up as a case report in the Journal of Opthalmology.

Now, we don’t know with a high degree of certainty that Fosamax caused the eye disease. The only way to prove it would be to take the drug again and see if my condition worsened. Of course, I am not going to do that. So, dear readers, it is hard to know what to tell you about taking Fosamax or related drugs. The one thing I can say with certainty though is that we need much better treatments for this common and sometimes debilitating disease.

The number of older people with fractures related to osteoporosis is huge. The National Osteoporosis Foundation (NOF) estimates that 1 of every 2 women and 1 of every 4 men 50 years or older will experience a fracture. Think about it. That’s 50% of women and 25% of men. Many of these fractures will occur as the result of a low trauma event, such as a fall from a standing height. They are considered fragility fractures because our big bones (hip, shoulder, and spine) are not supposed to break when we fall.

According to the NOF,

“the annual number of osteoporotic fractures that occur exceeds the incidence of heart attack, stroke, and breast cancer combined.”

Despite the magnitude of the problem, we have yet to take this disease as seriously as those other conditions. Perhaps, it is because we associate the condition with fragile little old ladies who gradually shrink and bend over. Most of us don’t think of it as a killer or a cause of major disability. But that is not correct.

Second fractures are common, particularly, for individuals who sustain a hip or vertebral fracture. And, the disability after a fragility fracture can be significant. Up to 85% of older adults who have fallen experience a syndrome known as “fear of falling” that causes them to alter their gait and become less active. Hip fracture, in particular, is associated with a significant increase in the first year after the fracture.

So, it is pretty disturbing to read the results of a recent study, “Patterns of Prescription Drug Use Before and After Fragility Fracture” published in the August 22 online issue of JAMA Internal Medicine. It turns out that not only are we failing to reduce the overall use of drugs that are associated with fractures, but only a fraction of the number of people who are eligible for prescriptions for bone-strengthening drugs are actually getting them.

Drugs that increase the risk of fracture

The researchers, led by Jeffrey Munson MD from the Department of Medicine at Dartmouth, looked at 2007-2011 data from Medicare beneficiaries to determine whether their prescriptions for drugs known to increase fracture risk were changed after they sustained their fracture. Here is what they found:

  • Three-fourth of the 168,133 beneficiaries who survived a fragility fracture were using a risky drug at the time of the fracture
  • More than half of the patients were taking at least one drug that increases fall risk prior to their fracture; slightly less than half were taking at least 1 drug that decreases bone density
  • Although some of the drugs were stopped in a small number of people after the fracture, about the same number of risky new drugs were prescribed

Drugs that increase the risk of fracture fall into three categories:

1. Drugs that increase the risk of falls, such as opiates (used by 35% of the cohort), selective serotonin reuptake inhibitors (SSRIs) (by 26%), thiazide diuretics (by 23%), and nonbenzodiazipine sedative hypnotics (by 11%).

2. Drugs that decrease bone density, including proton pump inhibitors (used by 26% of the cohort), anticonvulsants (by 9%), and oral or inhaled glucocorticoids (by 17%).

3. Drugs that are associated with fractures, but the mechanism is unclear. These drugs included loop diuretics and antipsychotics.

A full list of drugs in the study found in the here.

Bone-strengthening drugs

The study also examined whether or not patients were prescribed the most common type of bone-strengthening drug, oral bisphosphonates, once the fracture had occurred. Consistent with other studies about the dismally low use of bisphosphonates after osteoporosis-related fractures, this study found that less than one-quarter of patients had filled a prescription for a bone-strengthening drug either before, or, more egregiously, after their fracture. It is important to note that the study design did not allow the capture of data on the use of IV bisphosphonates, but this probably didn’t dramatically affect the results because only 2.5% of the group were using this type of drug prior to their fracture.

Why aren’t we doing better?

There are a number of reasons why we may not be doing better when it comes to discontinuing drugs that increase the risk of fractures. It may be that the consequence of discontinuing the drug is worse than its continued use.

For example, people with intractable asthma may require glucocorticoids in order to control their symptoms. In other cases, the underlying condition itself may be the real culprit and not the drug—anti-Parkinsons disease drugs come to mind.

In other cases, it may be a matter of optimizing the dose of the drug—for example, diuretics—so that orthostatic hypotension, due to dehydration, does not contribute to falling propensity. But in other cases, such as opiates, substituting less risky drugs could be a key intervention that reduces the risk of fracture.

Similarly, there are many reasons why people with osteoporosis are not taking bisphosphonates. Doctors may not be prescribing them when they are needed or patients may be refusing them because of fear of the uncommon, but serious complications of jaw necrosis and spontaneous femur fractures that have been reported.

I believe that one of the biggest problems related to drugs, falls, and fractures is that no one “owns” osteoporosis management after a fracture. Primary care docs are pretty good about screening women (men, not so much) for low bone density. But some people with low bone density may slip into frank osteoporosis that isn’t discovered until after a fragility fracture occurs. That is what happened in my case.

Further, most people in the United States get their care in a non-integrated, non-system of healthcare. When they fall and sustain a fragility fracture, they almost always end up in an ER with a follow-up from an orthopedist. The ortho takes care of the fracture, but may or may not address the underlying bone pathology. No one thinks to ask WHY you fell or WHY you broke a big bone, like the hip or shoulder, after a fall.

Population health programs for osteoporosis

This is where population health programs for bone health come in. Not to diminish the role of the PCP, but bone health and treatment of osteoporosis is pretty complicated and the consequences of failure to diagnosis and properly treat are huge, not only because of the impact on the person’s life, but also because of the cost of care.

Because there is so much emotion around the current treatment options for osteoporosis, a specialist with a high degree of knowledge about the physiology and pathophysiology of bones and the pharmacology of the various bone-strengthening drugs can be quite valuable in helping a patient make the right choice for her (or him). I spent 45 minutes on the phone with the bone health specialist going over the recent literature before making my treatment decision. Let’s be frank here…what PCP would even have 45 minutes to spend with you to just talk about the science?

Conclusion

If we are going to make a dent in the tsunami of fragility fractures coming down the pike as the population ages, we are going to need to have programs that take the management of populations at risk for osteoporosis as seriously as heart failure, asthma, or diabetes. We must keep in mind that falls are not “just falls” and fragility fractures are not “just fractures.” They are painful, traumatic events that have the potential to alter a person’s life forever. We simply must do better.