FDA Review Advises Caution In Using Bone-Building Drugs.

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  • Anonymous
    Anonymous Member Posts: 1,376
    edited August 2012

    cp418,

    thanks again for your WATCHFUL playing it forward for all of us.  This is so frightening.  Coming so quickly after learning the STATINS can push people into Type 2 Diabetes.  I've had 2 friends taking stains because of their family medical histories, and BOTH of them were having problems with high fasting blood glucose tests.  It really makes it so difficult to make wise choices about our health, esp. those of us taking AI's and watching bone density levels changing.

    THANK YOU AGAIN, cp418.

  • lago
    lago Member Posts: 17,186
    edited May 2012

    My onc doesn't treat osteopenia. I was diagnosed with slight osteopenia before chemo. We added calcium. I already increased my D. Stopped drinking diet soda. I did lose a tiny bit (.1%)more being tested 9 months after chemo (5 months after starting ALs and also in chemopause). My mom was diagnosed with it. I'm small boned and Caucasian so I do have risk factors. I do ex ercise.

    I am in no rush to get on this until there is a problem. The issue I see is when you are on it for a long time without a break. I had read a theory that  these drugs build up your bone and eventually your system stops doing it on their own because the drug is doing it IF you are on it for a long time. The way these drug builds up your bone isn't the same.

    Since I'm on the ESD (AI) my bones will continue to be monitored. I will do what even I need to do as far as exercise, food, supplements to keep away from this drug. I will NOT take it for osteopenia!

  • LtotheK
    LtotheK Member Posts: 2,095
    edited May 2012

    Very much like breast cancer, we have to weigh the small possibility of severe side effects against the possibility of fracture.  I know from fracturing my ankle that a spine fracture would change my life.  Recovery takes a long time for me, and the body is never the same afterwards.  My risk of fracture is not nothing.  My chance of jaw necrosis is a mere fraction of that risk.  But I still wondering if these drugs actually do what they are meant to.

    VR is completely right, but from my perspective, I am mightily tired of "individualized treatment" which is often a stand-in for "take a shot, the jury is out".  In my case, it was often "go with your gut" because they just don't have enough study.  It was my "choice" to wear a lymphedema sleeve flying, there isn't enough study to say for sure it's right for my risk.  It was my "choice" to do chemo after a world-famous oncologist told me they just don't know what the right protocol is for young women (half of the outcomes for post-meno women are exactly the reverse in women under 40).  It was my "choice" to take a biophosphonate because there seem to be few other options for a 40 yr old in menopause.

    There is a big difference between a drug actually being good for a part of the population and a lack of information as to whether it truly does what it is intended.  I've noted over the years that if large, well-publicized studies are pointing fingers at a drug, there's a good chance it'll go out of favor shortly. Edited to add:  it is fairly well established these drugs are not appropriate for osteopenia.  The problem seems to be for those of us with osteoporosis (mine is in the spine, not in the hip and wrist).

    With that, I think I'm going to play around on my rebounder a little more frequently.

  • doxie
    doxie Member Posts: 1,455
    edited May 2012

    voraciousreader, Thanks for the tip on a Gnant Zometa study.  I'll look into this.  I'm not worried about the jaw SE since it's so rare, more the quality of bone these drugs build.  

    I know the orals are different than the infusions, but haven't researched deeply into this.  Keeping my bone density steady (actually a normal decline considered medically acceptable - why should any decline be acceptable?) when not on AIs is not the same as when on them.  I've just started so won't know until the next DEXA scan if AIs will deplete my bones.  The lay scientist in me wants to see evidence of a need.  

     So if someone is very good with bone building exercise, Vit D/Calcium/Mag intake, no smoking/limited drinking/etc, then do bisphosphonates cause the worst of the SEs vs someone who almost entirely relies on these drugs for their bone health?  Anyone stumble upon research addressing this?  

  • LtotheK
    LtotheK Member Posts: 2,095
    edited May 2012

    VR, I think I've seen study on this, but I'd need to dig. 

    Exercise is wonderful, but studies do seem to indicate you need 4x a week of weight training to make a dent.  As it turns out, walking is not a great bone builder.  Running, yes.  Yoga, elliptical and swimming not so much. Well, heck.  I do the latter, the former make my knees hurt.

    My personal take:  what it takes to get the right kind of exercise is a lot for a working girl.  4x a week--ha!  I get to the gym frequently, but I'm not doing weight training that often.  And even if I did, I really wonder if it would have an effect on osteoporosis to reverse it.

    By the way, the studies on caffeine consumption seem to indicate it's not a big risk factor.  And the sugar/alkaline diet link is widely debunked.  Limiting alcohol makes good sense.

    The rebounder is supposed to be good. 

  • doxie
    doxie Member Posts: 1,455
    edited May 2012

    LtotheK, Into her late 70s my mom did very well keeping her bone health up with weight training 3 x /week, until she stopped gardening and other outside activity because of my father's health issues.  Her bone mass plummeted 30%.  Over the years she has been on almost every bisphosphonate possible except zometa and prolia, but none in the last year.  What was missing?  Certainly her daily dose of Vit D from the sun.  

    I jog/run, climb stairs, walk w poles, and have a rebounder for nasty weather.  I've held off on a return to kettle bells, a great weight lifting activity, until I'm fully healed from rads.  I have a really stressful job at times.  I've made a pact with myself that if I don't exercise and take better overall care of myself, then I have to move to a lower paying less stressful position.   

    Only time will tell if AIs put a stop to the joint jarring activities.  Give up morning coffee???? Can't imagine it.  Probably couldn't get my butt out of bed to exercise.  I have given up on having red wine at dinner.  

    This is a very complex issue.  Hope we can tease it out a bit here. 

  • LtotheK
    LtotheK Member Posts: 2,095
    edited May 2012

    Great info, Doxie!  My thanks to you.  You sound like a really smart and sane person, I love this bargain with yourself about the job. Certainly so very true from my vantage.  I work far too much in an interesting, but overtaxing job.

    Seems like the alcohol is a bigger issue than caffeine from what I'm reading.  Though it does look like a glass now and then isn't going to make a difference.  I certainly love wine!  That is a killer for me to cut entirely.

    The reviews also show that cortisol affects osteoblasts.  Well, bingo.  I've always been a type A, and am sure wreaked havoc in a million ways through excess cortisol (breast cancer, for instance).  I am trying very hard, but it seems they need to come up with a new form of meditation to manage this monkey mind...Sealed 

  • doxie
    doxie Member Posts: 1,455
    edited May 2012

    LtotheK, Thanks, but am I ever fooling you!!!  Exercise before bc was to keep my sanity at least on the edge of normal.  If cortisol contributes to the risk of bc, I was doomed.  I've had years of flooding.  So need to watch it for bone health also now?  When I rank the worst things that have happened in my life, bc comes in 5th.  Bc is at least something that gives us, maybe, more pause than those "normal" trials in our lives, and more supported opportunity to initiate changes for the better.  The medical support, research, networks of women w bc, friends, family have made it so much easier to navigate bc treatment and fears.  

  • voraciousreader
    voraciousreader Member Posts: 7,496
    edited May 2012

    Most of the information that I based my care on has been thus far, incomplete. I patiently wait for the results of the TailorX trial, SOFT Trial, Gnant's Zometa study as well as the Azure Trial. Bottom line for me is that I try to make the best decision possible based on the most available information. I often revisit my decisions based on trends as well.



    Once again, I wish to recommend Eric Topol, MD's new book, The Creative Destruction of Medicine. In his book he discusses that the time will come when population based clinical trials will be unnecessary. Instead, with the help of genetics, we will be able to guide our treatments more carefully. We are seeing glimpses of this type of treatment with the OncotypeDX test.

  • coraleliz
    coraleliz Member Posts: 1,523
    edited May 2012
    Diagnosing osteopenia can be complicated in those of us with slight builds. We may be coming back osteopenic when we aren't. http://findarticles.com/p/articles/mi_m0CYD/is_21_34/ai_61621161/  I've read better articles on this but can't find them right now. So for those of us who work out regulary & do all the right things both exerciswise & dietwise(staying lean & healthy), we may be showing osteopenic when really we aren't. Somewhere I saw that the DEXA scan isn't accurate for those under 127lbs(not sure how they arrived at that number). Both my MO & PCP have told me that it would be a good idea for me to have this scan but neither one has ordered(dealt with my insurance) it for me & I haven't pushed. But if I want to go on a biphosphate to perhaps decrease my risk of BC reoccurance, I'm pretty sure I'll show up osteopenic. Family history-but maybe some weren't-we're all thin.......
  • purple32
    purple32 Member Posts: 3,188
    edited July 2012

    Joy said :

    When I said no, she said I worry too much about rare complications, but it's far more than ..."

    I dont blame you Joy. Your dr. is not worried because presumably YOUR DR. is not taking it!  I took the actonel and then saw on TV it caused sudden femur breaks and there was a class action against it.  My jawbone is thinning and  my bone density has gotten much worse over the yrs.  I have had 3 breaks .

    I am very much interested in the strontium.  Can you tell me more ?  I am currently researching it.

    THX

  • LtotheK
    LtotheK Member Posts: 2,095
    edited July 2012

    Hi Purple,  there are lots of great discussions on strontium here, you can do a search for it.  I think it's an interesting possibility, though in my research, some studies indicate it builds the outside of the bone, not the struts that create real strength within the bone.  Just my take: real, natural alternatives are hard to come by, and usually work in combination (calcium, lots of exercise, cutting alcohol, etc.)

  • luv_gardening
    luv_gardening Member Posts: 1,393
    edited July 2012

    Purple, all my strontium research is on my old computer.  It has limited studies, mostly for the strontium ranelate which is a pharmaceutical drug developed so they can extract money from patients, rather than give them strontium in cheaper natural forms.  It's taken up by the bones in place of calcium where repair is taking place, so it's best to exercise the hips and spine with weight bearing exercises to stress the bones before taking it.  I wonder whether the strontium is as strong as the calcium it's replacing and whether there might be long term SEs that haven't yet been discovered.  Since the problems with bisphosphonates are only surfacing now, it's always wise to remember that alternatives haven't been studied so intensively as Rx drugs. 

    Citrate also is important for bone strength but I don't know if the citrate in strontium citrate gets to our bones. 

    Citrate key in bone's nanostructure 

    Both bisphosphonates and strontium are taken up by the bone so they stay there for many years so if there are any problems they can't be removed.  So I only take a little.  Also when I have a bone scan the strontium will make it look like my density is greater due to the molecular weight of strontium.

    I eat some prunes each day although they too are controversial as they contain some growth factor (IGF-1) that may cause cancer to grow quicker and also contain boron which increases estrogen and testosterone if dietary magnesium is low. 

    No Bones About It: Eating Dried Plums Helps Prevent Fractures and Osteoporosis, Study Suggests 

    "Loss of bone volume accompanied by loss of trabecular connectivity is generally believed to be an irreversible process, but our observations suggest that dried plum improves trabecular microstructure of tibia after losses have already occurred."
    It's not all good news. Prunes may be a problem for people with cancer or even at risk of cancer.
     

    So maybe prunes can fill in the gaps where bisphosphonates and strontium might fail?

    Boron
    Boron, a trace mineral needed in only tiny amounts, was first discovered in 1910 as being required for plant development and health. In 1985 researchers discovered that humans also require boron. Some foods are good sources of boron, including pears, prunes, apples, raisins, and tomatoes. Studies have shown that 3 milligrams (mg) of boron daily reduces urinary excretion of calcium and magnesium, especially when dietary magnesium is low. Boron supplementation elevates the serum concentrations of 17 beta estradiol and testosterone, again only when dietary magnesium is low. This suggests that boron may promote bone health. However, there is no evidence that boron in bone health  supplements improves bone mineral density, decreases bone loss or decreases fractures.
     

    DNC: Bad News about Prunes 

    I hope that all makes sense as it's very late here. (I'm watching Wimbledon)

    General Disclaimer:  I have no medical or nutritional qualifications and this is not medical advice.  See your health professional for personalised advice.  (Of course they mostly know about standard of care so research everything thoroughly for yourself using reputable, relevant sources.)

  • luv_gardening
    luv_gardening Member Posts: 1,393
    edited July 2012

    Here's the Web MD page on strontium.  Strontium Treatment for Osteoporosis

    And this detailed article disputes the idea that natural strontium (not ranelate) only strengthens the outer part of the bone, not the inner structure.
    The Truth about Strontium Supplements, Side Effects, DEXA Results, Efficacy and More
    by Lara Pizzorno
     

    Strontium does NOT increase risk for fractures - quite the opposite

    If one is going to make a claim like "Several studies conclude that strontium causes the outer cortical bone to become thicker, actually reducing tensile strength. This increases the risk of fractures," it should be backed up with footnotes citing these studies, and they should be bona fide, peer-reviewed papers accessible on PubMed.

    Since no references were provided to substantiate this claim, I ran a search on PubMed for these "several studies" and could find nary a one. What I found were papers showing the exact opposite.

    ....

    Protein and pH ...the "citrate" form of natural strontium, specifically, should be the best.  The reason for this is that - unlike ranelic acid, a weird hydra-headed molecule never before seen by the human body - citrate actually helps make the body's pH more alkaline. This is very important because it helps prevent the low-grade metabolic acidosis - an overly acidic pH -that is caused by a diet too high in protein, is quite common in the U.S. and Canada, and causes bone loss. In fact, this is such an important health issue that Joe recently wrote an article about it, which was published in the British Journal of Nutrition in April 2010.[11]

    Data from US Third National Health and Nutrition Examination Survey (NHANES III) shows that the average American diet (i.e., the typical Western diet) is acid-producing and results in a state of chronic low-grade metabolic acidosis. This increases bone loss because an acid pH is a strong activator of osteoclasts, the cells that break down bone. In this case, the osteoclasts' activity is ramped up because when bone is broken down, calcium is released, and calcium restores a more alkaline pH.

    Taking strontium, specifically in the form of strontium citrate, will help you maintain a more alkaline pH.

    I haven't checked PubMed to see if this article is accurate so specific feedback quoting studies is most welcome.

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