Table of Contents
An increasing number of my patients with low to moderate fracture risk have been prescribed a bisphosphonate. To help readers of this blog, I have prepared this post with my recommended bisphosphonates osteoporosis guidelines.
Bisphosphonates Osteoporosis Guidelines
I am a Physiotherapist and I treat many patients with osteoporosis. My preferred modality is safe and effective osteoporosis physiotherapy treatment for the individual. However, most of my patients have taken or are prescribed an osteoporosis medication such as a bisphosphonate, Prolia or Forteo.
I am not philosophically against the use of pharmaceutical intervention. In many cases, it is the appropriate course for individuals who are at an elevated risk of fracture. However, I believe that all health care professionals who treat this population be familiar with these medications.
In this post, I will address several questions and topics related to bisphosphonate use:
- What Are Bisphosphonates
- Use of Bisphosphonates
- When to Stop Bisphosphonates • Bisphosphonate Drug Holiday
- Long Term Bisphosphonate Use
- Bisphosphonate Femur Fracture
- Alternatives to Bisphosphonates
What Are Bisphosphonates
Let’s start with a definition of bisphosphonates.
Bisphosphonates arrest the loss of bone density. They bind to the surface of bone and reduce the effects of bone loss caused by osteoclasts (cells that erode bone). Osteoblasts (cells that build bone) can be more effective when it comes to creating bone.
How do they work? An abstract on PubMed explains in more technical detail:
At the tissue level, they decrease the rate of bone resorption and turnover, increase bone mineral density, and maintain or improve structural and material properties of bone and thereby reduce the risk of fractures.
Popular brand name bisphosphonates include: Fosamax, Actonel, Boniva and Reclast and are also referred to as alendronate, risedronate, ibandronate and zoledronate.
Use of Bisphosphonates
The Endocrine Society issued its recommendations about bisphosphonate use in March of 2019. They recommend the following:
- We recommend initial treatment with bisphosphonates for postmenopausal women at high risk of fractures.
- Reassess fracture risk after 3 to 5 years of treatment. This applies to postmenopausal women with osteoporosis who are taking bisphosphonates. Women who remain at high risk of fractures should continue therapy, whereas those who are at low-to-moderate risk of fractures should be considered for a “bisphosphonate holiday.”
A bisphosphonate holiday is a temporary discontinuation of bisphosphonate for up to 5 years. This period may be longer depending on the bone mineral density and clinical circumstances of the individual patient.
These recommendations clearly indicate that individuals at a high risk of fracture start a bisphosphonate treatment program.
FDA Review
The US Federal Drug Administration initiated a review of the long term use of bisphosphonates and raised concerns associated with their use. They noticed an elevated risk of atypical femur fractures and esophageal cancer.
Why are people with low to moderate fracture risk prescribed an osteoporosis medication?
This question has become increasingly confusing and frustrating for people with low bone density. In a recent article in the New York Times on bisphosphonates even the physicians who are quoted disagree on appropriate bisphosphonate use.
FRAX Assessment
The World Health Organization has developed a tool called FRAX to assist individuals in determining their fracture risk. This is a good starting point and you should consult this tool to determine your fracture risk.
Pharmacist Kent MacLeod recommends that patients and their physicians use the online FRAX to determine fracture risk.
- In the US, bisphosphonates should be considered for an individual whose 10 hip year fracture risk is above 3% or their major fracture risk is above 20%.
- In Canada, bisphosphonates should be considered when an individual’s major fracture risk is above 20%. For individuals whose fracture risk is moderate (10 to 20%) pharmaceutical intervention may be considered dependent upon additional risk factors.
The decision has become more complicated now that studies are showing an increased risk of femoral shaft fractures for people who take bisphosphonates for an extended period of time.
In addition, the FDA recently announced an updated warning on kidney impairment associated with the use of Reclast.
Bisphosphonates or Prolia
In a recent interview I had with one of Canada’s leading Osteoporosis Specialists, Dr. Jonathan Adachi, I asked him why many physicians are switching patients from bisphosphonate treatment to Prolia.
He indicated that a physician should make the switch when “patients have side effects to the bisphosphonate, when there are declines in bone mineral density (BMD) or when patients sustain a fracture on bisphosphonates.”
Exercise Recommendations for Osteoporosis
Exercise is an essential ingredient to bone health. If you have osteoporosis, therapeutic exercise needs to be part of your osteoporosis treatment program.
But what exercises should you do and which ones should you avoid? What exercises build bone and which ones reduce your chance of a fracture? Is Yoga good for your bones? Who should you trust when it comes to exercises for osteoporosis?
A great resource on exercise and osteoporosis is my free, seven day email course called Exercise Recommendations for Osteoporosis. After you provide your email address, you will receive seven consecutive online educational videos on bone health — one lesson each day. You can look at the videos at anytime and as often as you like.
I cover important topics related to osteoporosis exercise including:
- Can exercise reverse osteoporosis?
- Stop the stoop — how to avoid kyphosis and rounded shoulders.
- Key components of an osteoporosis exercise program.
- Key principles of bone building.
- Exercises you should avoid if you have osteoporosis.
- Yoga and osteoporosis — should you practice yoga if you have osteoporosis?
- Core strength and osteoporosis — why is core strength important if you have osteoporosis?
Enter your email address and I will start you on this free course. I do not SPAM or share your email address (or any information) with third parties. You can unsubscribe from my mail list at any time.
When to Stop Bisphosphonates and Take a Drug Holiday
In 2013 the Journal Therapeutic Advances in Musculoskeletal Disease published a study (1) on bisphosphonate drug holiday. The study was by Diab and Watts, Bisphosphonate Drug Holiday.
The authors state that “it is difficult to find evidence to support the need for a drug holiday or to establish the effectiveness of treatment after restarting therapy.”
However, the authors do believe that “there is logic to support the following clinical scenarios.” The scenarios that Diab and Watts refer to in their bisphosphonate drug holiday study reflect the degree of risk of a fracture. Diab and Watts identify four risk levels and provide guidance for each risk level as it relates to the questions of when to stop bisphosphonates use.
Low Risk Fracture
Bisphosphonate treatment is not needed. Bisphosphonate treatment should be discontinued and not resumed until the patient meets treatment guidelines.
Mild Risk of Fracture
Use bisphosphonates for a 3 to 5 year period and then stop. The bisphosphonate drug holiday can continue until there has been a “significant loss” of bone mineral density.
Moderate Risk of Fracture
Use bisphosphonates for a 5 to 10 year period. At that point “offer a bisphosphonate drug holiday of 3 to 5 years or until there is significant loss of bone mineral density or the patient has a fracture, whichever comes first.”
High Risk of Fracture
Diab and Watts recommend “treat with bisphosphonate for 10 years, offer a ‘drug holiday’ of 1 to 2 years, until there is significant loss of bone mineral density or the patient has a fracture, whichever comes first.”
Long Term Bisphosphonate Use
What about long term bisphosphonate use and what about the possible implications?
On May 9, 2012 the U.S Food and Drug Administration (FDA) published an analysis on bisphosphonates longterm use in post-menopausal women.
According to the FDA, while bisphosphonate therapy has demonstrated “efficacy in preventing fractures in registration trials lasting 3 to 4 years … data on safety have raised concern regarding the optimal duration of use for achieving and maintaining protection against fractures”.
These safety concerns include increased risk of femoral shaft fractures, esophageal cancer and osteonecrosis of the jaw.
Long Term Bisphosphonate Use • Findings and Recommendation
The findings of this analysis were presented to a joint meeting of two FDA committees. The committees jointly decided that the data from the analysis “did not support a regulatory restriction on the duration of drug use”.
However, the joint committees did recommend that the labeling on bisphosphonate drugs be updated. Bisphophonate drugs now contain an “Important Limitation of Use” definition that states:
The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis.
What is the FDA Saying?
This recommendation can appear to fall short in terms of specifics. The recommendations probably reflect the fact that the study data reviewed by the FDA was, at times, inconsistent and incomplete.
In addition, the behaviour of bisphosphonate is quite complex and can vary from person to person and from brand to brand. Since bisphosphonates are absorbed into the bone during the treatment phase, they can persist for years – even after cessation of treatment. Further, there have been no long terms studies of the effects of bisphosphonates after cessation.
Basically, the FDA researchers state that more work and study has to be done. Individuals should consult, on a regular basis, with their health provider on what is right for them.
This regular evaluation should include an individual assessment of the risks and benefits of bisphosphonate therapy and patient preference. A good source for your health provider to use in evaluating your fracture risk is the online FRAX tool developed by the World Health Organization and the International Osteoporosis Foundation.
Clearly, the FDA and researchers are grappling with this complex issue.
Bisphosphonates Osteoporosis Guidelines • FDA
The New England Journal of Medicine published another article to accompany the FDA review. This article was written by a group of physicians at a number of medical institutes across the United States.
In the article, the physicians review the data and shed more light on the results. They state the following:
- Vertebral Fractures (i.e., fractures of the spine): Although evidence is limited regarding the risk of fracture with the continuation of bisphosphonate therapy beyond 3 to 5 years, data from randomized controlled trials generally suggest that the risk of vertebral fracture is reduced.
- Nonvertebral Fractures (i.e., fractures of the wrist, ribs, hip, etc): The consistent evidence of a statistically significant reduction in nonvertebral fractures with the continuation of bisphosphonates is lacking.
Further, this team provides guidance regarding continued use of bisphosphonates. The caveat is that these recommendations could change as more research is published.
- Patients with low bone mineral density at the femoral neck (T score below −2.5) after 3 to 5 years of treatment are at the highest risk for vertebral fractures and therefore appear to benefit most from continuation of bisphosphonates.
- Patients with an existing vertebral fracture who have a somewhat higher (although not higher than −2.0) T score for bone mineral density may also benefit from continued therapy.
- Patients with a femoral neck T score above −2.0 have a low risk of vertebral fracture and are unlikely to benefit from continued treatment.
As you can see, these physicians recommend that patients with osteoporosis and a high fracture risk should continue bisphosphonate therapy. Those with low or moderate risk of fracture will probably not see material benefit from continued use of this therapy.
Long Term Bisphosphonate Use • Recommendation
Since each individual’s medical profile is unique, I strongly encourage you to discuss this issue with your physician. Hopefully, articles like this one make you a more informed patient.
As a general rule, if you are at a high risk of fracture, continued use of bisphosphonates is probably the prudent path.
If you are at low or moderate risk of fracture, you need to weigh the risks associated with long term use of this drug (as defined earlier in this article). Research is showing that there is no evidence that bisphoshonates cause a significant reduction in nonvertebral fractures.
A well designed osteoporosis exercise program is something that everyone should be following.
Conclusion
Expect to hear more about this debate in the coming years as researchers spend more resources examining the long term effects of this drug. Clearly, people within the FDA and researchers in the field have concerns with the continued long term use of this drug and its effectiveness when it comes to reducing fracture risk. The problem today is that there is not enough data to provide definitive guidance or change the FDA’s regulatory position with regard to this drug.
FDA Review in More Detail
The FDA article goes into a lot of detail as to what the study involved. For those of you not interested in reviewing the article but still interested in the mechanics of the study, here is a brief summary.
The FDA examined the long term effects of three bisphosphonates: Fosamax, Reclast and Actonel. One study group took the bisphosphonate and the other took a placebo. The FDA studied the effect of the various bisphosphonates on changes in the bone density in the femoral neck and the lumbar spine. They also looked the effect on vertebral fractures.
The FDA found that continued use of bisphosphonate therapy beyond five years lead to “maintenance of bone mineral density in the femoral neck and further increases in bone mineral density at the lumbar spine”.
However, the FDA review found that the “data raise[s] the question of whether continued bisphosphonate therapy imparts additional fracture-prevention benefit, relative to cessation of therapy after 5 years.” It was this finding that caused the FDA to issue the label change mentioned above.
Exercise Recommendations for Osteoporosis
Exercise is an essential ingredient to bone health. If you have osteoporosis, therapeutic exercise needs to be part of your osteoporosis treatment program.
But what exercises should you do and which ones should you avoid? What exercises build bone and which ones reduce your chance of a fracture? Is Yoga good for your bones? Who should you trust when it comes to exercises for osteoporosis?
A great resource on exercise and osteoporosis is my free, seven day email course called Exercise Recommendations for Osteoporosis. After you provide your email address, you will receive seven consecutive online educational videos on bone health — one lesson each day. You can look at the videos at anytime and as often as you like.
I cover important topics related to osteoporosis exercise including:
- Can exercise reverse osteoporosis?
- Stop the stoop — how to avoid kyphosis and rounded shoulders.
- Key components of an osteoporosis exercise program.
- Key principles of bone building.
- Exercises you should avoid if you have osteoporosis.
- Yoga and osteoporosis — should you practice yoga if you have osteoporosis?
- Core strength and osteoporosis — why is core strength important if you have osteoporosis?
Enter your email address and I will start you on this free course. I do not SPAM or share your email address (or any information) with third parties. You can unsubscribe from my mail list at any time.
Bisphosphonate Femur Fracture
Can you experience a femur fracture as a result of bisphosphonate treatment?
A study was just recently released in the Journal of the American Medical Association (JAMA) on prolonged bisphosphonate therapy and the increased risk of femoral shaft fractures in older women. Treatment for five years or longer was associated with an increased risk of femoral shaft fracture.
In the following video, I discuss this study and its implications for you. The study can be found at the JAMA website.
Atypical Fracture Bisphosphonate
Today, I’d like to talk about a recent study that was published in JAMA, the Journal of the American Medical Association. They spoke about unusual fractures related to bisphosphonate use.
As a person with osteoporosis, or low bone density, if you’re on a bisphosphonate, you might be a little bit concerned about this study.
First of all, I’d like to take you into the anatomy of where these fractures are occurring.
Anatomy of Fracture
We’re going to zoom right in to the bones of the lower leg, specifically the thighbone or femur. Most typical osteoporotic fractures occur in the neck of the femur.
Typical Osteoporotic Fracture
The typical osteoporotic fracture occurs in that part of the femur because that’s the part of the femur that has more trabecular bone. The study showed that these unusual fractures were in the region of the femur below the intertrochanteric area, or also referred to as the shaft of the femur.
What’s concerning is that the shaft of the femur has a lot more cortical bone, which is usually known as really good, hard bone.
People who are on bisphosphonates for over five years, have an effect not just on the trabecular bone, but also on the cortical bone.
Effect of Bisphosphonates
If you are at all concerned, you should definitely talk to your doctor before you discontinue your medication.
Chances are your doctor might recommend that you continue your bisphosphonate if you are already at a high fracture risk, and you haven’t been taking a bisphosphonate for five years.
If you are at a moderate fracture risk or a low-moderate fracture risk, you should definitely have a discussion with your doctor as to whether or not a bisphosphonate is the best approach for you.
Whether you are at a low, moderate, or high fracture risk, we know that exercise helps build quality of bone.
But exercise is going to help you recover from a fracture as well, so you really should consider starting an exercise program.
Exercise, Safe Daily Activities, Nutrition and Vitamin D
The choice to take a bisphosphonate prescription (or any other osteoporosis medication) is yours. However, you should always follow a prescribed exercise program for osteoporosis.
All individuals, regardless of fracture risk, should:
- Follow a prescribed osteoporosis exercise plan that not only includes weight bearing for bone building but also includes balance, posture, strength and flexibility exercises that reduce the chance of a fall.
- Practice perfect posture and modify how they do their household chores (known as their activities of daily living), exercise routine, yoga practice, and pilates moves that can increase their risk of fracture.
- Determine whether you are getting adequate Vitamin D.
- Follow a proper nutrition program for your bone health.
Prolia Injections
Dr Adachi indicated that many physicians are shifting their patients from bisphosphonates to Prolia. However, Prolia is not without its challenges as discussed in my post, How Long Can You Take Prolia.
References
- Diab, Dima and Watts, Nelson, Bisphosphonate Drug Holiday, Therapeutic Advances in Musculoskeletal Disease, 2013 Jun.
Conclusion
These bisphosphonates osteoporosis guidelines have covered a wide range of questions my clients have about bisphosphonate use including
- when to stop bisphosphonates.
- the implications of long term bisphosphonate use.
- bisphosphonate femoral fracture.
- alternatives to bisphosphonates.
Osteoporosis Guidelines
For more information, check out my Osteoporosis Guidelines.
Comments
September 8, 2011 at 11:33am
Elizabeth Stewart
Thank you so much for this update on bisphosphonates. I'm so confused about this treatment. I live in the UK and because I have refused the offer of this drug, they won't do another DEXA to see if my bone density has improved with my exercise and diet "prescription". I'm only 52 and although I have a poor spinal T score (I also have stomach problems), I don't feel this drug is right for me at this time. And I'm being made to feel guilty for my choices! Thanks for addressing these issues as I never feel I get enough information from the medical community here. In the future, will you be looking into the benefits of different types of calcium (Whole food calcium in particular), K2, and or strontium? Thanks again Margaret for keeping us informed.
September 12, 2011 at 7:29am
Margaret Martin replies
Hi Elizabeth, Your right to have a DEXA should not be dependent on your choice intervention. The recommendation is to wait 2 - 3 years between DEXA scans because of the slow rate of turnover that our bones have. I have been hearing from several women who are being "made to feel guilty" for their choices. You know your body best of all and along with your health practitioner should be encouraged to make the best decision for you. Many doctors are educated about osteoporosis from the pharmaceutical companies and so it is the option they go to. Most doctors have little or no training in exercise and nutrition. We will have future blogs on strontium and K2. Thank you for the suggestion. Be well.
September 9, 2011 at 12:44pm
Ruth Layberry
I was prescribed Actonel, but after 3 months I knew this was not for me. I had terrible acid
reflux for three days after taking the meds. I told my doctor that I was going off this medicine and was going to up my exercise level ( following your workouts) plus a three day a week regime weight lifting. I also make sure I am taking vit. D.
Thanks for this timely areticle, Margaret.
Sincerely, Ruth
February 15, 2016 at 8:43am
Joni colclasure
Hi, Margaret, I just recently got diagnosed with moderate to severe osteoporosis with a high risk of spinal fracture. My doctor prescribed fosomax. I took my first pill and that evening my calves got all balled up and were cramping, I had a pain in my groin and my knuckle on my right hand next to my pinkie was swollen and hurt like I had broke it. Needless to say I have not taken any other pill. I don't know what to do now. I researched all those types of medications and they all had horrible side effects. I'm only 57 so however I decide to treat this will be my new lifestyle I adopt which will be for many, many years. God willing... I have been looking for real foods and other supplements to treat my osteoporosis as well as exercise that is safe. At the present time I am taking a calcium 600 + vitamin D3 combination chewable, one in the morning one at night. The only other medication I take is synthroid which I have been on for 30 years.
February 15, 2016 at 3:43pm
Joni colclasure
I'm looking for more natural way to build my bone density back and didn't know if you knew of success of building bone back without the medications that my doctor offered me such as fosomax, etc.....
March 10, 2018 at 3:54pm
Maria
Margaret, as a 51 year old small frame, white female recently diagnosed with osteoporosis (high risk), I am truly overwhelmed. I have not even hit menopause, and I'm on a thyroid drug known to cause bone loss. Looking back, I have been fairly active in my life although I never made calcium a priority in my life (even with knowledge of my mother's history of osteoporosis and fractures). My doctor has recommended Boniva, but I"m not convinced this drug or Prolia is right for me given that I'm only 51! Thank goodness I've not had any fractures to date. Also, thank goodness for your books and blogs!. Since discovering them, I am focused daily on my diet, my posture exercises, balance and flexibility, and strength and cardiovascular exercises. I am also focused on the mechanics of how I move throughout the day. With the expertise you have provided, I am hopeful I can improve my bone density or at least mitigate further loss. I am also going to find a physiotherapist near me to help monitor my exercise plan. Thank you for your wonderful books and your attention to osteoporosis.
March 10, 2018 at 4:59pm
Margaret Martin replies
Maria, you are not alone in how you are feeling about your diagnosis. You figure you're doing all the right things and a left hook comes out from no where. I love how you have channeled your energy into taking care of yourself and so glad that my books and blogs can be of service.
The good news is that you have not yet hit menopause. By this I mean that armed with the information you now have on building bone it is much easier to do so when you have hormones on your side. If you know you are in perimenopause or when you hit menopause you could discuss HRT with your gynecologist as an option for you.
Thank you for taking the time to comment and for your kind words. Be strong.
August 19, 2018 at 4:38pm
Pam Jofs
Hi Margaret,
Your information is incredibly helpful. I am a healthcare professional and diagnosed when I was in my 40's with osteopenia which has now turned to high risk osteoporosis at age 59. I'm really confused as my latest DEXA scan says "FRAX not reported because some T-score at or below -2.5. What do they mean by that, do you have any idea? Also, my spine went from -2.4 to -3.1 in 15 months. Is that at all possible? I do have smoldering myeloma but my oncologist does not believe that my low levels of myeloma markers are contributing as I'm the perfect setup for OP. Strong family history including my mother and both grandmothers, I'm 5 ft 2 inches, 105 pounds and light skinned caucasian. I am wondering if a more rigorous exercise regimen (I power walk 5-6 days a week for 30 minutes) and adding Vitamin K to my diet would work as I take D3, Magnesium glycinate and eat calcium rich foods in abundance. I am so torn as I am pondering over such a drastic change to my spine. My hip went from -2.4--2.7. Thank you for taking the time to read this and I intend reading your books and more. Pam
August 23, 2018 at 4:15pm
Richard Martin replies
Hi Pam: Thanks for contacting us. There are too many questions in your post for Margaret to address. You can setup a phone or online consultation where these questions can get the attention that they deserve: http://melioguide.com/services/phone-or-online-consultation/
August 12, 2020 at 1:42am
Dafna
Hi Margaret,
Thank you for doing such a great work in simplifying this complex information for people who have Osteoporosis.
I personally was prescribed bisphosphonates, and decided not to take it because of the possible side effects.
In my case, the diagnosis was based mainly on Bone Turnover Markers which indicated a high turnover (CTX).
What is your opinion about these markers compared to FRAX?
April 23, 2021 at 7:17am
Shirley
I just being told I got thin bones and I got to have oral bisphosphonate tablets I really don’t understand theses tablets what I got to take can you help me if someone had them and how do you feel now
April 23, 2021 at 8:26am
Richard Martin replies
Hi Shirley. You should discuss your medications and their implications with your physician.