Teriparatide and the risk of nonvertebral fractures in women with postmenopausal osteoporosis
Abstract
PURPOSE: In the Fracture Prevention Trial, the risks of any nonvertebral fracture (relative risk [RR] 0.65, P=0.04) and any fragility nonvertebral fracture (RR 0.47, P=0.02) were significantly reduced in the teriparatide 20 μg/day (teriparatide) versus placebo group. The purpose of this analysis was to examine the efficacy of teriparatide versus placebo on a variety of other nonvertebral fracture outcomes.
MATERIALS AND METHODS: The Fracture Prevention Trial was a double-blind trial of postmenopausal women with osteoporosis and vertebral fractures randomly assigned to teriparatide (N=541) or placebo (N=544) administered by daily self-injection for a median of 19 months and a median follow-up of 21 months. All patients received calcium and vitamin D supplementation. Reports of nonvertebral fractures were collected from patients at each visit and confirmed by review of a radiograph or written radiology report. Nonvertebral fractures were recorded for the following sites: distal radius/wrist, humerus, rib/clavicle, hip, ankle, distal foot, pelvis, or other. Pathological fractures and fractures of the face, skull, metacarpals, fingers and toes were excluded. Fractures were classified by investigators as fragility or traumatic fractures. The three endpoints considered were six nonvertebral sites (nonvert-6), a set of common nonvertebral fractures described in a Food and Drug Administration Guidance document for the treatment and prevention of postmenopausal osteoporosis (FDA),…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 544 participants or records.
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