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Efficacy and tolerability of bazedoxifene in Mexican girls with osteoporosis: a subgroup evaluation of a randomized section Three trial.
Menopause. 2016 Jul;23(7):771-7
Authors: Palacios S, Williams R, Mirkin S, Pan Ok, Arias L, Komm BS
Summary
OBJECTIVE: Bazedoxifene (BZA) is a selective estrogen receptor modulator that reduces fracture danger and bone turnover in postmenopausal girls with osteoporosis. This evaluation evaluated BZA’s results on bone mineral density (BMD) and bone turnover in Mexican girls with osteoporosis from the worldwide pivotal trial (Examine Evaluating Bazedoxifene Acetate in Osteoporosis in Postmenopausal Girls).
METHODS: On this Three-year, section Three, randomized, double-blind trial, wholesome postmenopausal girls with osteoporosis (N?=?7,492) acquired BZA 20 or 40?mg/d, raloxifene 60?mg/d, or placebo. The subanalyses of Mexican girls assessed serum concentrations of osteocalcin and collagen kind 1 C-telopeptide, BMD, and tolerability with BZA 20?mg/d versus placebo.
RESULTS: Within the Mexican subgroup (BZA, n?=?39; placebo, n?=?37) at month 12, BZA 20?mg/d produced vital (P?<?Zero.001) share decreases from baseline in osteocalcin (-40.5 vs -18.5) and C-telopeptide (-45.7 vs -29.four). For BZA versus placebo, share change in BMD from baseline to month 36 was Three.Three versus Zero.64 for lumbar backbone, -Zero.18 versus -1.eight for complete hip, Zero.21 versus -2.6 for femoral neck, and -Zero.55 versus -1.four for femoral trochanter; variations weren’t statistically vital. Outcomes had been similar to the general research inhabitants wherein variations had been statistically vital. Frequent opposed occasions (?20%) included arthralgia, again ache, gastritis, headache, influenza, and ache; none led to check withdrawal.
CONCLUSIONS: In Mexican girls with osteoporosis, BZA was properly tolerated and appears to supply BMD adjustments similar to the worldwide section Three inhabitants, though variations versus placebo weren’t statistically vital on this smaller subgroup.
PMID: 27116464 [PubMed – indexed for MEDLINE]