Proton pump inhibitors (PPI) Does Not Affect Bone Homeostasis in Healthy Postmenopausal Women
Proton pump inhibitors (PPIs) have been widely used for decades to treat acid-related diseases. PPIs exhibit a well-established safety profile and reduce gastric acid more effectively than histamine-2 receptor antagonists or antacids.
However, observational studies suggest that long-term PPI therapy is associated with osteoporotic fractures, hypomagnesaemia, and vitamin B12 deficiency. A large body of epidemiological data has detected an association between PPI use and fracture risk. The clinical importance of this association is unclear. Recent population-based epidemiological studies have generated conflicting results about a relationship between chronic PPI therapy and fracture risk.
Although a plausible mechanism explaining a causal relationship between PPI use and fracture has not been definitively established.
Study evaluated the effects of PPIs on bone homeostasis in postmenopausal women, a population with the highest prevalence of osteoporosis and related fractures.
Although some studies have detected an association between PPI use and fractures in postmenopausal women, prospective studies have found no differences in BMD between PPI users and nonusers.
Authors undertook this prospective, double-blind, randomized, placebo-controlled trial to evaluate the effects of PPIs on bone homeostasis in healthy postmenopausal women.
Overall, study result found no evidence of bone loss among healthy postmenopausal women who received esomeprazole or dexlansoprazole for 26 weeks compared with those who received placebo. Their findings indicate that the treatment with a PPI has no clinically meaningful effects on bone homeostasis.
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Background & Aims
Epidemiological studies have associated proton pump inhibitor (PPI) therapy with osteoporotic fractures, but it is not clear if PPIs directly cause osteoporosis. Authors evaluated the effect of dexlansoprazole and esomeprazole on bone turnover, bone mineral density (BMD), true fractional calcium absorption (TFCA), serum and urine levels of minerals, and levels of parathyroid hormone (PTH) in healthy postmenopausal women.
Methods
Authors performed a prospective, multicenter, double-blind study of 115 healthy, postmenopausal women (45 to 75 years of age) from November 4, 2010, through August 7, 2014. Women were randomly assigned to groups given dexlansoprazole (60 mg), esomeprazole (40 mg), or placebo daily for 26 weeks. Authors measured plasma levels of procollagen type 1 N-terminal propeptide (P1NP) and C-terminal telopeptide of type 1 collagen (CTX) at 0 (baseline), 13, and 26 weeks. Primary outcomes were percent change in P1NP and CTX between weeks 0 and 26. Authors also measured changes in serum and urine levels of mineral, BMD, PTH (all subjects), and TFCA (n = 30).
Results
Between baseline and week 26, there were no significant within-group differences in markers of bone turnover; there was a nonsignificant increase in CTX levels in the dexlansoprazole group (0.12 ng/mL). The esomeprazole and dexlansoprazole groups had significantly increased levels of P1NP (18.2% and 19.2%, respectively) and CTX (22.0% and 27.4%, respectively) at week 26 compared with the placebo group, although these values remained within normal ranges. There were no statistically significant differences between groups in serum or urine levels of minerals, BMD, or PTH at week 26. PPI therapy did not reduce TFCA.
Conclusions
In a prospective study of postmenopausal women, authors found significant increases in markers of bone turnover in women given PPI therapy compared with women given placebo, but levels remained within the normal reference range. Authors found no significant differences among groups in changes in BMD, PTH, serum or urine levels of minerals, or TFCA. Their findings indicate that 26 weeks of treatment with a PPI has no clinically meaningful effects on bone homeostasis.
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