Effect of Parathyroid Hormone (1-34) on Fractures and Bone Mineral Density in Postmenopausal Women with Osteoporosis

作者：Robert M. Neer, Claude D. Arnaud, José Zanchetta, Richard L. Prince, Gregory Gaich, Jean‐Yves Reginster, Anthony B. Hodsman, Erik Fink Eriksen, Sophia Ish‐Shalom, Harry K. Genant, Ouhong Wang, Dan Mellström, Erik S. Oefjord, Ewa Marcinowska-Suchowierska, Jorma Salmi, Henk Mulder, Johan Halse, Andrzej Sawicki, Bruce Mitlak · 发表于：New England Journal of Medicine · 年份：2001 · DOI：10.1056/nejm200105103441904 · 被引用次数：4593 · 研究领域：Parathyroid Disorders and Treatments、Bone health and osteoporosis research、Bone health and treatments

BACKGROUND: Once-daily injections of parathyroid hormone or its amino-terminal fragments increase bone formation and bone mass without causing hypercalcemia, but their effects on fractures are unknown. METHODS: We randomly assigned 1637 postmenopausal women with prior vertebral fractures to receive 20 or 40 microg of parathyroid hormone (1-34) or placebo, administered subcutaneously by the women daily. We obtained vertebral radiographs at base line and at the end of the study (median duration of observation, 21 months) and performed serial measurements of bone mass by dual-energy x-ray absorptiometry. RESULTS: New vertebral fractures occurred in 14 percent of the women in the placebo group and in 5 percent and 4 percent, respectively, of the women in the 20-microg and 40-microg parathyroid hormone groups; the respective relative risks of fracture in the 20-microg and 40-microg groups, as compared with the placebo group, were 0.35 and 0.31 (95 percent confidence intervals, 0.22 to 0.55 and 0.19 to 0.50). New nonvertebral fragility fractures occurred in 6 percent of the women in the placebo group and in 3 percent of those in each parathyroid hormone group (relative risk, 0.47 and 0.46, respectively [95 percent confidence intervals, 0.25 to 0.88 and 0.25 to 0.861). As compared with placebo, the 20-microg and 40-microg doses of parathyroid hormone increased bone mineral density by 9 and 13 more percentage points in the lumbar spine and by 3 and 6 more percentage points in the fem...