FDA Review Advises Caution In Using Bone-Building Drugs.
FDA Review Advises Caution In Using Bone-Building Drugs.
The New York Times (5/10, Parker-Pope) "Well" blog reports, "In an unusual move that may prompt millions of women to rethink their use of popular bone-building drugs, the Food and Drug Administration published an analysis that suggested caution against long-term use of the drugs, but fell short of issuing specific recommendations." The FDA analysis, published in the New England Journal of Medicine, "offered little specific guidance about long-term use, saying that the decision to continue or stop treatment should be based on an individual assessment of risks, benefits and preferences discussed between a patient and her doctor." The FDA review did indicate that "women at low risk for fracture or with a bone density near normal may be good candidates to stop therapy after three to five years, but older patients at higher fracture risk and bone density 'in the osteoporotic range' may benefit from continued therapy." Bloomberg News (5/10, Pollack) also covers this story.
New Cautions About Long-Term Use of Bone Drugs
http://well.blogs.nytimes.com/2012/05/09/new-cautions-about-long-term-use-of-bone-drugs/
Comments
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I can't get any of those links to work. Here's the New England Journal of Medicine link, if it works.
Bisphosphonates for Osteoporosis - Where Do We Go from Here?
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This doesn't suprise me because I recently read about how these drugs build bone when monitored by scans but haven't been shown to decrease fractures. I would think using these drugs to prevent BC reoccurence is where the "individual assessment of risks, benefits and preferences" comes into play.
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Maybe now I get why after 2 years of Zometa I had three vertebrae fracture over a period of three months. How frustrating and scary.
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If you read John Abramson, MD's book, Overdosed America, he devotes a chapter to bone building drugs. Basically, what he says is that the bone building drugs merely coat the bones rather than build bone from within. It's like white washing the walls. It doesn't improve the integrity of the structure. What the new study is suggesting is that we need to carefully decide what population of women should use these drugs and for how long. If you read Dr. Abramson's book.. He explains that the majority of women will NOT get a fracture in their lifetime regardless of whether or not they choose to use this class of drugs. The study's downfall is that they stopped short of making a recommendation leaving doctors in a quandary.
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Chickadee... That must be awfully painful. I am recovering from a broken foot...I can only imagine!!
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The bisphosphonates cause the bone to rebuild in a distinct pattern, not the woven pattern of normal bone rebuilding. Fractures that are due to the bisphosphonates are caused when the bone breaks along a line of the abnormal bone growth architecture. Normal bone rebuilding in a woven pattern is less likely to fracture.
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Kitty is right, that is exactly how my endocrinologist described it. The original bone is built on amazing strut systems, the bios can't build that type of complex bone.
I am currently on Fosamax for my spine osteoporosis. I dunno what to say, I'm pretty sure these drugs are bunk, but I don't want to be on Prolia in two years if it keeps going like this. I've added 500 mg of calcium, but it constipates me so badly that I have to take a lot of magnesium to counteract it, and that is supposed to be problematic.
I go to the gym, try to eat better, and take the bios for a couple of years, 'tis all I can do for now...
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LtotheK, are you taking calcium carbonate, or calcium citrate? I've found that even just a couple of Tums (calcium carbonate) can block me up, but calcium citrate (e.g., Citracal) doesn't do that.
YMMV, of course, but you might try switching if you're on the carbonate version.
What the article says is pretty much what my med onco and my osteoporosis doc (endocrinologist) have been telling me all along. The mechanism of action of bisphosphonates, and the pathophysiology of the SE's they cause, are poorly understood. Their use should be reserved for only those people at high risk of fractures, or who've already had a fracture due to poor bone density. That's their party line.
otter
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Here is what Dr. Abramson has to say in Chapter 13 of Overdosed America....Notice there are TWO types of bone....Notice which type the biophosphate drugs target AND how:
In 1995, Fosamax, the brand name for alendronate, was the first of the new generation of drugs approved by the FDA for the treatment of osteoporosis. Fosamax works by attaching itself to the surface of bone, interposed between the osteoclasts and the bone the osteoclasts are trying to absorb. Randomized clinical trials of Fosamax published in medical journals show dramatic reductions in the relative risk of hip fracture for women with osteoporosis. In a study published in JAMA in 1998, for example, women with an average age of 68 and a T score of - 2.5 or less who took Fosamax for four years were 56 percent less likely to suffer a hip fracture than women in the control group.
This sounds like very good news for women with osteoporosis, but how many hip fractures were really prevented? With no drug therapy at all, women with osteoporosis had a 99.5 percent chance of making it through each year without a hip fracture -- pretty good odds. With drug therapy, their odds improved to 99.8 percent. In other words, taking the drugs decreased their risk of hip fracture from 0.5 percent per year to 0.2 percent per year. This tiny decrease in absolute risk translates into the study's reported 56 percent reduction in relative risk. The bottom line is that 81 women with osteoporosis have to take Fosamax for 4.2 years, at a cost of more than $300,000, to prevent one hip fracture. (This benefit does not include a reduction of less serious fractures, including wrist and vertebral fractures. Most vertebral fractures cause no symptoms.)
[. . . ]
What about using these drugs to prevent osteoporosis? Fosamax and Actonel were approved by the FDA to treat women with osteopenia based on studies that showed that they significantly increase the bone density of these women. It is important to remember, however, that bone density is only a surrogate end point; the real reason for taking these drugs is to reduce fractures, and hip fractures in particular. The study of Fosamax published in JAMA in 1998 (mentioned earlier) also included women with osteopenia. Did Fosamax reduce their risk of fracture? The results show that the risk of hip fractures actually went up 84 percent with Fosamax treatment.* The risk of wrist fractures increased by about 50 percent (that figure may be statistically significant -- but this can't be determined from the data as presented in the article).
How can it be that drugs approved for the prevention and treatment of osteoporosis succeed in increasing bone density but have such limited impact on reducing hip fractures? The answer can only inspire awe at Mother Nature's elegance. There are two types of bone. Eighty percent of the body's bone is made up of the hard and dense outer layer called cortical bone. In some areas of the body, bones also have an internal structure of trabecular bone, which works like an organic three-dimensional geodesic dome, providing additional strength in the areas of the skeleton most vulnerable to fracture, such as the hips, wrists, and spine.
The lacelike structure of trabecular bone creates a much greater surface area than the densely packed cortical bone and therefore allows the former to be more metabolically active when the body needs calcium. Its greater metabolic activity also makes trabecular bone more vulnerable than cortical bone to the changed balance between osteoclast and osteoblast activity. As a result, when bone mass starts to decline in women, trabecular bone is lost more quickly than is cortical bone. Once the architecture of these internal struts is lost, there is no structure left onto which calcium can be added. (See Figure 13-1.) The new bone, formed as a result of taking the osteoporosis drugs, is then formed primarily on the outer part of the bone, the cortical bone. This increases the score on the bone density test but does not necessarily contribute proportionately to fracture resistance." -
Thanks for the calc carb tip, otter! did not know!
Wow, this is so articulate. So where does that leave us osteo-challenged ladies??
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LtotheK....Where does it leave us osteo-challenged ladies, including me who is presently recovering from a broken foot.....hmmmm....I'm not sure! I think though, that Dr. Abramson nails it when he talks about the beauty of Mother Nature. There aren't many things that man can artificially create that can rise to the level of Mother Nature. If you read the entire chapter in his book, you will then be able to appreciate what he's talking about. Bone density machines pretty much measure the outer part of bone. The bone density meds, coat the outer bone (white washing) which according to Dr. Abramson, "...increases the score on the bone density test but does not necessarily contribute proportionately to fracture resistance."
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That book sounds interesting, VR. I was recently told I had some osteopenia in my hips. I asked my onc about doing Zometa, etc... and he didn't think it was necessary...wanted me to increase calcium, calcium rich foods and weight bearing exercise. Says we'll scan again in 2 years. I have to say I tend to feel more comfortable with that approach than throwing more drugs in me. And it sounds like it's better to try to build bone yourself than have the drug do it for you. Crazy, huh?
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Thank you all who posted with such clarifying explanations!
I have osteopenia, and several years ago, my PCP wanted me on Fosamax. After reviewing the side effects, I absolutely refused. I concentrated instead on taking in plenty of calcium, in the way of both food and supplements.
After my BC dx, I had another bone scan. It was pretty much the same as it was several years ago - in other words, I hadn't lost any more bone density, nor had I progressed to osteoporosis.
In the fall, I'll start Arimidex. My MO mentioned that she might also put me on one of those "bone building" drugs, and now I am even more determined to say no.
I will instead concentrate on better nutrition, supplements, and now that I'm losing weight, increased and more regular weight-bearing exercises.
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Just want to add to the mix that I am doing Zometa infusions every 6 months for 3 years as prevention of recurrence of BC per the Gnant study. Not happy at all because I worry that while I might be reducing my chances of BC recurrence, I might be increasing my chances of making my bones more brittle. Recovering from my latest broken bone after 3 Zometa infusions gives me pause...
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VR ~ I asked my MO about taking Zometa for recurrence...and he said the current studies are conflicting. Have you seen that?
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Susan. I am very aware of the data. Following the last San Antonio meeting where Dr. Gnant presented his latest follow-up, it seems for my age category, it appears received the most benefit. I went even further than most.... I emailed Dr. Gnant and he was kind enough to respond. He further explained his findings. Not all age categories are seeing the same benefit. If you have questions, you should revisit the data with your doctor and see if your age group fits the criteria.
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Interesting. I will revisit with my dr. I seem to recall that because I am pre-meno, it wasn't proven to be of benefit to me. I will do some more research, thanks.
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I was pre-meno when I started but did ovarian suppression and was 53 at diagnosis. Younger women did not show benefit. Older women like me received the most benefit.
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Okay.. that's what I thought I remembered. I was 43 at diagnosis..45 now...and very pre-meno. I guess I'll just stick with weight bearing exercise and calcium.
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I wish you well.
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My endocrinologist used the FRAX tool (google it) to ascertain whether I should take bisphosphonates or not. Although I have osteoporosis of the spine (T -2.5) and less so at the hip (T -1.9),the advice was NOT to treat.My chances of a fracture in the next 10 years is estimated to be very low.
The endo said that the long-term side effects of bisphosphonates are not nice and that for a post menopausal woman,taking calcium supplements can also be problematic as there is research suggesting increased likelihood of atherosclerosis for post menopausal women. It is better to get your calcium form the diet.
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Hmmm. My MO is insisting that I have zometa infusions ea 6 months. I have multiple women in my family who have/had osteoporosis and severely diminished QOL at the end of their lives. Increasing Vit D helped keep my density stable in my last DEXA scan, even through chemo and much less exercise. This is the only thing I've disagreed on with my MO. I wanted to wait until there was a problem. He insisted we stay ahead of the problem. I'm post-meno so that may also be a consideration. Not sure what to do.
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Sam52 ~ what have you heard of the long-term side effects? I couldn't find much on long term except for the rare condition of jaw necrosis.
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My issue is similar to some here. My grandmother basically died of osteoporosis after multiple hip breaks. Although, she lived to 90, so from my vantage, not too shabby (especially after cancer at 40). I am going to talk very plainly to my endocrinologist about these drugs. I had a family likelihood, but I'm sure the chemo didn't help matters, and furthermore, Tamoxifen in young/pre-meno women seems to do what the AIs do to bone.
It's oh-so-complicated, hard to know what to do. I'm trying everything: calcium, exercise (could do more of it), and diet modification. I hear sugar and caffeine should be limited, too.
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To the "stay ahead of the problem" recommendation, that would make sense if these drugs worked. But it seems clearer and clearer based on the research they do not build bone with integrity. This information has become even more widely available in the two years since my diagnosis.
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Dr. Abramson's book was published in 2006... Two weeks before the Vioxx debacle. His first chapter is devoted to..... Vioxx. Why he chose to write about Vioxx first is interesting. He noticed within his family practice, patients were demanding Vioxx prescriptions. At the same time he was reading his medical journals carefully, very, very carefully and he had questions about the data.
The book is extremely enlightening. He explains statistics in an unforgettable way. The book is even more relevant to read now as it was when it was published. Much of what he questioned is now being answered... slowly, but we are getting answers... -
Wow, this is really interesting. I have broken my hip (a few months after starting Fosamax) and I also had 3 fractured vertebrae last year. Then, recently, I had jaw pain. So I quit Fosamax a few months ago even though I have severe osteoporosis. Taking calcium citrate with D and jogging daily.
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I have osteoporosis in my hips already so my MO won't put me on an AI unless I take a bisphosphonate. When I said no, she said I worry too much about rare complications, but it's far more than that for me. I see women on here who have ONJ and it's a dreadful thing. No one can guarantee they won't need a tooth out for ten years which is the half-life of these drugs. I just needed root canal therapy and another old capped tooth may not last many years. And the lowering of fractures just doesn't seem as likely as their research seems to show.
Why not fix my bones naturally? I take calcium/D, vitamin K2, a little strontium, but not a lot as it may be another band-aid. I use a "cheap" vibration platform that cost way too much, but cheaper than a year at the gym. I make sure the vibration is felt strongly in my hips by changing position. I also put weights on my ankles at bedtime and lay on the bed reading while lifting my legs in sets, on my back and sides. I got lazy for a few months when I was going through some depression, but now realise I can never drop the exercises again.
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Susan'sgarden....the side effects range from osteonecrosis of the jaw, to esophageal cancer (with oral bisphosphonates, esp Fosamax), and spontaneous fractures of the femur.
I also know of several people who had to stop Fosamax because of severe ulceration in the throat.
Over the 3 years I took Fosamax, my bone density declined from osteopenia to osteoporosis - however, this may well have been due in part to undiagnosed hyperparathyroid disease, which was surgically corrected 2 years ago. (Hyperparathyroidism and breast cancer seem to be correlated in some way).
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I just want to mention in regard to the Gnant study of Zometa (an infusion bisphosphonate) which was to give a total of 6 infusions over 3 years to prevent recurrence of breast cancer.....The sample population being studied has been followed now for 8 years since the COMPLETION of the 3 years of Zometa and NO PATIENT has gotten osteonecrosis of the jaw, which was indicated as the most common of the side effects. I had read somewhere that the folks who took Fosomex were more inclined to get the femur fractures.....
Again, I think it is worth reiterating that for SOME people, this class of medication is important. However, just like with screening, physicians need to figure out who is at low, medium and high risk and then create a plan that works for the INDIVIDUAL patient.
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