Men's Osteoporosis Support GroupNew osteoporosis drug; twice-monthly risedronate; male atherosclerosis and osteoporosis; fracture rates comparing persistence and adherence with oral bisphosphonates, and PPIs and fracture risk IDrugs. 2009 Dec;12(12):799-809. Odanacatib, a cathepsin K inhibitor for the treatment of osteoporosis and other skeletal disorders associated with excessive bone remodeling. Lewiecki EM. PMID: 19943223. This is just a heads up on a potential new osteoporosis medication that is currently in clinical trials, Odanacatib (MK-0822, MK-822). They are currently recruiting for Phase III clinical trials that will also test for fracture risk reduction. Only time will tell how effective an osteoporosis treatment this will be and what, if any, risks are associated with its use. For now the author notes, "In a phase II clinical trial, weekly doses of odanacatib increased bone mineral density (BMD) and reduced bone turnover markers in postmenopausal women with low BMD. No tolerability concerns or evidence of skeletal toxicity were reported." J Clin Densitom. 2009 Nov 24. [Epub ahead of print]. Risedronate on 2 Consecutive Days a Month Reduced Vertebral Fracture Risk at 1Year Compared With Historical Placebo. Watts NB, Brown JP, Cline G. PMID: 19942469. This study used historical controls who had taken risedronate 5 mg/day to compare fracture results for people taking 75 mg risedronate (Actonel) on two consecutive days per month, each for a total of one year's duration. The results showed, "At 12mo, vertebral fractures occurred in 5.1% and 1.0% of the placebo and 5-mg risedronate historical patients, respectively. In the risedronate 5mg/d and 75mg 2CDM groups, fracture incidence was 1.5% and 1.1%, respectively." Thus authors concluded, "Based on comparisons with the historical control group, risedronate 75mg 2CDM appears as effective as the 5-mg/d dose in reducing the risk of new vertebral fractures in the first year of treatment." Editor's comments: This is an interesting article for a couple of reasons. It is the first instance I've seen of using historical controls and it shows similar effectiveness when taking either 5 mg/day of risedronate or two consecutive 75-mg doses. Assuming safety and untoward reactions are similar, it would obviously be less of a problem to take the two doses per month. This is especially so since the medication must be taken on an empty stomach and the individual must remain upright, and not eat for at least one-half hour, and longer, preferably. There is also another Update showing risedronate 150 mg/month was as effective as the 5-mg/day dosing. So presumably the 75-mg/twice monthly dose in the Watts and others article above was used before it was known that a single dose had equal effectiveness. Note that the Actonel website shows that a single pill is available for the 5-mg/day, 35-mg/week, 75-mg/twice monthly, and 150-mg/month dosages. Presumably alendronate (Fosamax) would be equally effective with once-monthly dosing, but it is not available in anything greater than a 70-mg dose (used for once-weekly dosing) and has not be confirmed effective in clinical trials. Osteoporos Int. 2009 Nov 21. [Epub ahead of print]. Low bone mineral density is not associated with angiographically determined coronary atherosclerosis in men. Beer S. PMID: 19936870. The study participants had a mean age of 64, and included a total of 623 consecutive men undergoing coronary angiography to detect coronary artery disease (CAD), narrowing of the coronary artery lumen. A total of 272 of the men had either osteopenia or osteoporosis. But multivariate logistic regression analysis showed that neither osteopenia nor osteoporosis was associated with an increased prevalence of CAD. In summary, this study showed that, although men undergoing coronary angiography have a prevalence of low bone mineral density (BMD), their low BMD is not associated with angiographically determined coronary atherosclerosis. Editor's comments. So my interpretation of this study is that about one-third of the men undergoing coronary angiography will have osteopenia and 10% will have osteoporosis, probably not caused whatsoever by the CAD, more likely related to their age and other factors. Likewise, men with osteoporosis are not at increased risk of CAD because of their low bone density. Patient Prefer Adherence. 2009 Nov 3;3:25-30. Influence on persistence and adherence with oral bisphosphonates on fracture rates in osteoporosis. Höer A and others. PMID: 19936142. In this study there were 4451 patients in the database with osteoporosis who were compared regarding how persistent they were in taking their medications, as well, their adherence was analyzed. Persistence was defined as the duration of continuous therapy; adherence was measured in terms of the medication possession ratio (MPR). The fracture risk reduction at 180 days for persistent patients compared to non-persistent was 29%; at 360 days it was 45%. Those who had good adherence (MPR >/= 0.8) reduced fracture risk by 39%. The authors concluded, "In patients with osteoporosis-related fractures, good persistence and adherence to oral bisphosphonates reduced fracture risk significantly." Editor's comments. This study confirms what has been shown in another Update, that persistently taking your osteoporosis medication reduces your risk of fractures. Gastroenterology. 2009 Nov 17. [Epub ahead of print], Proton Pump Inhibitor Use is not Associated with Osteoporosis or Accelerated Bone Mineral Density Loss. Targownik LE. PMID: 19931262. This study used a large Canadian database of people taking proton pump inhibitor (PPI) medications to see if there was a correlation between taking PPIs and osteoporosis. The results showed, "PPI use was not associated either with having osteoporosis at either the hip (OR 0.84 [95% CI 0.55-1.34]) or the lumbar spine (OR 0.79 [95 % CI: 0.59-1.06]) for PPI use exceeding 1500 doses over the previous 5 years. In the longitudinal study there was also no significant decrease in BMD at either site attributable to PPI use." The authors concluded, "PPI use does not appear to be associated with either the presence of osteoporosis or accelerated BMD loss. The association between PPI use and hip fracture is likely related to factors independent of osteoporosis." Editor's comments: These results conflict with those noted in a previous Update which found the use of PPIs for 7 or more years is associated with significantly increased risk of an osteoporosis-related fracture. Another Update discussed a study in postmenopausal women using omeprazole (a PPI). Those authors concluded, "Omeprazole use is associated with an increased risk of vertebral fractures in postmenopausal women. Further studies are required to determine the mechanism of the association between the underlying gastric disease, omeprazole use, and risk of osteoporotic fractures." The two studies discussed in the Updates reported only on increased fracture incidence, whereas the Targownik study reported on changes in BMD, which would be expected to decrease if the PPI was a significant fracture risk factor. However, they found no decrease in BMD or increased fracture risk. Bottom line: more research is needed, perhaps with a prospective study, to come to a definitive conclusion regarding the risks of taking PPIs. Thinking logically on the subject, we aren't taking PPIs because it has been normal to get acid reflux throughout all of human history. It is likely associated with the modern human diet which is totally different from the one humans evolved eating for about 99% of their existence. It is most likely related to the quantity and type of foods eaten and to the highly processed nature of modern foods, completely different from what prehistoric humans ate. These changes are self-evident by just checking U.S. obesity rates since 1985 (quickly scroll down the page to see the maps changing yearly), which have increased dramatically in the last 25 years, and which I suspect correspond to increasing intake of PPIs, although I don't know a study to verify that conclusion. Thus I would expect to find that people who are overweight and taking PPIs, and who lose weight by modifying the quantity and/or quality of what they eat, will reduce or eliminate their need for PPIs. I know that was definitely the case for me when I changed to a nutrient-dense, low-fat, low-sugar, starch-based diet. And I've read many testimonials from other people who did the same with equal results regarding stopping acid reflux and/or PPI use. So discuss this with your physician if you want to attempt to stop PPIs.
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