Popular osteoporosis drugs are coming under scrutiny. Bisphosphonate drugs such as Actonel, Boniva, Fosamax and Reclast are supposed to build strong bones and prevent fractures.
But an odd thing has happened. Over the last few years, evidence has been building that these drugs may increase the risk of an unusual type of fracture (Journal of the American Medical Association, Oct. 6, 2010).
The FDA has just issued a safety announcement warning about “atypical fractures of the thigh.” These femur fractures can occur without a fall, collision or trauma. Just walking may bring on this uncommon break.
Readers of this column have been reporting this kind of broken bone for some time: “I had been on Fosamax for seven years when I started having leg pain. The doctors I saw could not find anything wrong. Then one morning in the steam room at the gym my left femur just snapped in half. It was a weird break and I had to have a rod put in.
“Less than six months later, I was rushing around my son’s kitchen getting my grandkids’ breakfast and my right femur broke, making me fall. It broke in the same place as the left and now I have rods in both legs.”
Another reader has a similar story: “I began taking Actonel in December of 2004. In October 2008, I was walking down the hall in my home. I heard a loud pop in my right femur, and down I went. I was rushed to the hospital and went into surgery the next day. A long rod was inserted.
In February 2010, I began to have pain in my left femur every step I took. The doctor had it x-rayed and I have a hairline fracture in my left femur. I’ve had to stay off my leg or use a walker until the fracture heals. I am off Fosamax, and the doctor says I shouldn’t take Actonel or Reclast either.”
These unexpected fractures are not common, and researchers don’t know how often they happen. Nor does anyone know if they will become more frequent in the future, as the number of people taking bisphosphonates for many years increases. They are not the only concern about such drugs, however.
The FDA is reviewing data that may link bisphosphonates to a higher risk for esophageal cancer. In addition, an irregular heart rhythm called atrial fibrillation has been linked to injected bisphosphonates (Journal of Clinical Oncology, online Oct. 12, 2010). Whether atrial fib might also occur with oral medicine remains controversial.
In March 2008, the FDA alerted prescribers that severe bone, joint or muscle pain can occur in patients taking bisphosphonate drugs such as Fosamax (alendronate sodium), Actonel, Reclast and Boniva. Some doctors were not aware that the drugs themselves could be the source of such debilitating pain.
A bisphosphonate drug might still be the best choice for a person with osteoporosis, but she should know about other options. We have prepared a Guide to Osteoporosis outlining the pros and cons of the various osteoporosis prescriptions and non-drug approaches.

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  1. s. m. campbell
    Reply

    Is it safe or prudent to have a DEXA scan if you had spinal fusion with rods a couple of years ago?

  2. DD
    Reply

    I had my first reclast at 40 due to early menopause. It made me really sick for a week and then I was fine. I will see how well it works this summer. I was in my 30’s when I found out I had osteoporosis. Good luck! DD

  3. Joanna M
    Reply

    Hi Joan
    would you tell me please how many mg of magnesium you are taking?
    Thanks Joanna

  4. K,W,
    Reply

    I have a family history of osteoporosis. I have been taking weekly bisphonates (Fosamex) for about 10 years (61 years old). I take calcium and vitamin D. I’ve been told my vitamin D levels are fine. I exercise daily. After initial improvement in my bone density, my scans have shown a decline in bone density over the last several years. My sister who is on Actonal has had similar problems and was recently switched to annual injections. I have had some ongoing doubts about bisphonates but haven’t known what I can do. Recently, I have read some very positive reports about Strontium as a safe effective treatment for osteoporosis. Would the People’s Pharmacy comment on this treatment option?
    PEOPLE’S PHARMACY RESPONSE: STRONTIUM RANELATE IS PRESCRIBED IN EUROPE, BUT IT HAS NOT BEEN APPROVED IN THE U.S. WE DON’T HAVE DATA TO SHOW HOW THE OTC STRONTIUM WOULD COMPARE.

  5. Joan S
    Reply

    I was diagnosed with severe osteoporosis of the spine, femur, and osteopenia of the hip in 1999 at age 65. I took Fosamax for 5 yrs and continued to lose bone. I stopped the drug and started taking 680 mg of strontium per day, plus 4000 units of Vit D, and magnesium, along with weight bearing walking. I just had my 4th Dexascan and my spine, femur are in the osteopenia stage, and my hip is only -1.2. There was an increase of 16.1% in BMD since the last Dexascan. No side effects to worry about plus it is cheaper than the drugs.

  6. T.oguz
    Reply

    I am just 30 years old, and because of the cushing’s and pregnancy I have severe osteoporosis. I had compression fractures on my spine. I haven’t started my osteoporosis treatment yet, but I was wondering if anybody got reclast at young age and experienced any weird side effects. And does it really work???

  7. J DROZDA
    Reply

    I took Actonel for 5 years. At 56 I am active, take calcium citrate with D and Magnesium. I also do wt. bearing exercise 3 times per week. I fell on concrete. I just slipped. My pelvis has 3 breaks due to the fall. My DR. said the breaks were so bad that I looked like I was in a car crash.
    My bone density has improved to osteo-penia just taking my calcium supplements. I have been off all bone medications for 5 years. I know actonel caused my severe pelvic breaks. FDA needs to come clean. I will never take them again.

  8. AH
    Reply

    I just was diagnosed with osteonpenia. I refused to take Evista that my former doctor prescribed. I googled and found out that strontium, along with calcium, vitamin D, vitamin k2, and magnesium can help build bone naturally. It also said don’t take calcium and strontium at the same time since they compete with each other. It said it is best to take it 3 hours after the last meal. I am planning to start this regimen January 1, 2011.

  9. J P
    Reply

    I took Boniva for six months and then found my stomach could no longer handle any kind of nsaid, like ibuprofen, so I quit. That problem has gone away. However, shortly after I started using it I started experiencing shoulder pain from an unknown source that several doctors have been unable to diagnose.
    I have had x-rays, an mri and a ct scan done to help diagnose it to no avail. I have been going to physical therapy off and on for two years now to manage the pain and now must do 50 minutes of exercises specifically for this pain three times per week – forever. The exercises do not alleviate the pain, only subdue it. I blame the bisphosphonate.
    It makes me ill to see Sally Field inviting others to have problems similar to mine or those of the other people who have made comments. I no longer trust new drugs. If you think drug companies actually care about your health, think again. They exist only to make money!

  10. Rocket Scientist
    Reply

    Zero gravity causes astronauts to lose bone density. I know that NASA uses weight-bearing exercise as one preventative measure. That’s why I carry weights in a backpack an hour a day. I see that NASA is also experimenting with vibration. Go to http://www.nasa.gov and search.

  11. RS
    Reply

    Two highly hormone-responsive breast cancer diagnoses (the 2nd–a recurrence–occurred while taking tamoxifen), so I had to be put into menopause prematurely (via monthly Zoladex injections for a year and then finally via an oophorectomy) so I could take Arimidex (oh, joy).
    Between the chemo, menopause & Arimidex–thus depleting my body of just about every last drop of estrogen–I knew my bones would be problematic eventually, but I just got the results from my 2nd bone density scan that my bones have thinned a lot. I am only 41 and just 2 years ago at the start of my chemo when I had a baseline bone density test, my bones were “normal.”
    I have been taking Vitamin D3 in doses high enough to maintain good D levels (around 50 ng/mL, though I’d like to be higher… and insisting on getting my levels monitored to ensure that) along with Calcium and Magnesium and I have been eating healthily and exercising regularly with a focus on weight-baring exercises. I had really hoped it wouldn’t be a problem for several *years* at the earliest.
    My onc. now wants me to start on bisphosphonates (Fosamax or of the injectible versions). I DO NOT want to take them!
    They are deceptive… they DO NOT build bone but rather slow bone resorption in an effort to offset the slowed bone building that defines osteoporosis with the net result of the “appearance” of greater bone density in the scans but in reality resulting in a weaker bone “structure”… certainly not “stronger bones” as the marketing campaign goes.
    But what do I do? I thought I was doing the right things, but the cancer meds that deprive my body of estrogen to a level beyond normal menopause are doing my my bones in. Obviously I’ve considered stopping the Arimidex, but with one recurrence under my belt already, I’d feel like I’m playing Russian roulette with my cancer. I don’t know what to do at this point… and I am still reeling from the bone density results I got two days ago. I am looking for natural alternatives, behavior modifications, etc… anything that might help.
    PEOPLE’S PHARMACY RESPONSE: TALK THIS OVER WITH YOUR DOCTOR. WE ARE SENDING OUR GUIDE TO OSTEOPOROSIS SO YOU WILL BE INFORMED ABOUT EVISTA, CALCITONIN, AND OTHER NON-BISPHOSPHONATE OPTIONS.

  12. TB
    Reply

    I cannot find information on how to get off weekly Actonel after 8 years of taking it. I don’t want to wait till it is pulled off the market. Help, please.

  13. BY
    Reply

    Have been taking bisphosphonates for 13 years. Mostly Fosamax, but Boniva for about 2 years. In July I started having pain in my left thigh. Had an MRI, some x-rays and was scheduled to start physical therapy for muscle relief, when I had a small fall… or my left femur broke and I fell. This was a month ago. During the surgery several attempts were made to install rods, with additional breakage of the femur.
    Now have a plate, cadaver bone, etc in the leg. Stopped fosamax following surgery. Am taking calcium, vitamin D, magnesium. I am 67, live in Fl, was walking a mile or two daily, plus involved in outdoor sports. Not over weight, a non-smoker, who does not drink alcohol. Very boring. And now wondering how long to get this stuff out of my system and what else to do in the meantime. Yeah, where do we go now?

  14. AY
    Reply

    I was diagnosed with Osteoporosis last year and my doctor prescribed Actonel. I took the once monthly dosage and I have experienced bone ache and stomach pains. Over the past two months, my stomach pains became so bad that I was admitted to hospital for an endoscopy, colonoscopy, ultrasound and CT scan. Finally, when no cause could be found, I was given a PillCam which took pictures of my insides for 8 hours.
    This showed that my small intestine was ulcerated and the cause of this was ACTONEL. After this was diagnosed, I now have suspicions about my appendectomy which occurred last year after I had been taking the dreaded medication for only a few months.
    Could that too have been caused by ACTONEL? I believe that this medication is a problem and obviously I have discontinued taking it. My recent bone density scan has revealed that although my spine has improved slightly, my femurs are both worse and my doctor wants me to have injections, which I am reluctant to do. I have been taking calcium and vitamin D supplements and much walking and weight bearing exercises. I am 53 – where do I go now???

  15. Rx
    Reply

    I used Fosamax for less than a year. I had six years of horrible dental surgeries and was extremely ill. My surgeon said he found necrosis of the jawbone. I had to have a tooth extracted (emergency) – I was sent for an implant and the first thing the specialist did was test me for Fosamax (which was STILL in my blood – he was puzzled that my levels were so high, since I didn’t take it long and it had been a while since I quit). Because of that, no implant.
    I had to get a very complicated bridge which considerably altered my bite. I am still trying to figure out why everything went so wrong and what caused the serious problems I am dealing with today. I am sure some are attributable to the meds I was given. I don’t think the doctors are educated much about side effects! I’ve been doing my own research.
    I also have an area of what feels like thickened bone in my lower jaw.
    I think bio-identical hormones, nutrition and exercise are the answer, not these horrible drugs! I am so glad I stopped the Fosamax when I did. I wish I had never taken it at all…. I wonder, does that nice Sally Field really know about the product she is pushing?

  16. Linda
    Reply

    I would like to know if anyone has reported having extra bone grow after taking fosomax or boniva . After taking these drugs I began to have pain in my left knee, I had a MRI done and it showed I had extra bone growing on it, so I had it removed. My doctor said the meds had nothing to do with it so I continued to take them for a year. My dentist found extra bone growing in my mouth so I quit taking them and will always believe the meds is what caused this problem. Now I have jaw pain to contend with, I know part of this is from TMJ, but I wonder if the meds made it worst. My doctor still tells me Boniva and Fosomax won’t grow bone but if it can thicken bone why can’t it grow bone also?

  17. RKM, MD
    Reply

    Bisphosphonates have their problems, but they remain among the best solution for osteoporosis – especially in early post menopause.
    Better solutions are being developed, such as recently approved Denosumab which does not remain in bone for many years if a complication develops. However, the challenge is to develop a drug which can, in a reasonable manner, increase new bone formation, not just inhibit bone turnover.
    One problem that is often overlooked is that it is important to obtain a normal level of vitamin D. Taking bisphonates without adequate vitamin D is all too common and only exaggerates the problem of inhibiting bone turnover without the needed stimulus for new bone formation.
    Additionally: whoever attempted to fix that fracture used a screw that was too long, and positioned it much to high. It should be in the lower half of the femoral head! When this fails because the screw cuts out of the upper femoral head, it cannot be blamed on bisphosphonates!

  18. Bob R
    Reply

    In December 2007 my wife had been having pain in her right hip. Then on the 20th she walked into the bank lobby, turned right, and the right femur broke a couple inches below her hip replacement prosthesis. Three surgeries were required to repair it. She had been taking Fosomax for 10 to 12 years. Now her doctor has her taking Reclast.

  19. Rocket Scientist
    Reply

    Funny – my orthopedist says he knows little about the bone-density drugs. The drug companies have pushed them through the gynecologists, a specialty that has nothing to do with bones but sees the most women. I feel I was tricked into thinking I would eventually have a problem so I would have the scans and buy the drugs. I was on Fosamax for more than 10 years. Now, I carry weights in a backpack to naturally build my bone density.

  20. Carmen S.
    Reply

    The article on bisphosphonate drugs and bone fractures is most interesting. I have a different, although bone related question.
    50 years ago I was injured roller skating. Over time my left hip lost its ability to rotate in the socket. My parents sought medical treatment, but it was not diagnosed properly until too much damage had been done to the socket. Hip replacement was not recommended because of my young age. Today I have no right hip, as it is completely fused into my pelvis (at about a 30 degree angle) and reads as one solid bone. I walk, but limp.
    Mobility is a problem and my lower back is often sore. I am afraid of falling as the left leg acts like a lever and catapults me forward. If I fracture my right leg, I would have a terrible fall and not be able to move at all. My question is: Are there any known “hip replacement” surgeries performed that actually make a new hip socket in the pelvis? Remember the ligaments and muscles on that side have not been fully used in 50+ years. My doctor is reluctant to perform the surgery. I know this is not a common issue, but any guidance you can provide of where to look would be appreciated.

  21. BW
    Reply

    I had to fall to break my right femur. (In the hospital parking lot on wet leaves as I was
    leaving my workout.) I had been on Fosomax for several years. My doc took me off it
    in the summer of 2009… I fell in November.
    I had read about “millions of women” breaking a femur or two after taking this apparently safe medication. I guess NOT.

  22. REK
    Reply

    Good article about the SE of bisphosphonates but no mention was given
    to the possible problem with the jaw bones.

  23. anna m.
    Reply

    I have never liked taking medication as I feared that sometimes side effects could be most harmful. Twice now I have experienced effects that made me pause to say the least.
    I was prescribed Arimidex after breast cancer and the joint pain was awful so I simply stopped taking the drug and the pain subsided considerably. Then several years later, I began to have pain in my legs–of a nature that seemed to stem from joint, muscle, and maybe nerve origins. I began taking Osteo Bi-Flex twice a day about a year ago, and things improved. Recently, I have had unexplained pains in my left leg which has often left me limping and just by chance I forgot to take the Osteo Bi-Flex for a couple of days.
    The pain disappeared, so I kind of naturally ascribed it to the lack of that medication in my system. So far, so good. Maybe the pain was caused by a build up in the system. Anyway, I now make an anti-inflammatory drink from fresh thyme, ginger, lemon and honey and feel much better. The pain has subsided a great deal and I instinctively feel that simple, natural remedies are probably best of all. That plus living a healthy life, enjoying the beauties of nature and laughing often!

  24. Al
    Reply

    The same thing also happened to my wife. She had been on Fosomax for about 8-10 years and then switched to Boniva and was on it for several years. One day she slipped and broke her left femur. A year later the same thing happened and she broke her right femur. She now has steel rods in both legs.

  25. Suzanne K
    Reply

    I have been experiencing “pins and needle” type tingling in my joints every night for several years. I only sense it when I am sleeping and my joints feel very hot. Could this be due to the Fosomax I have been on for about 10 years? I recently stopped taking it (3 months ago) because my stomach was so irritated and I thought maybe Fosomax was the problem.

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