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Original Article
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Volume 344:1434-1441 May 10, 2001 Number 19
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Effect of Parathyroid Hormone (1-34) on Fractures and Bone Mineral Density in Postmenopausal Women with Osteoporosis
Robert M. Neer, Claude D. Arnaud, Jose R. Zanchetta, Richard Prince, Gregory A. Gaich, Jean-Yves Reginster, Anthony B. Hodsman, Erik F. Eriksen, Sophia Ish-Shalom, Harry K. Genant, Ouhong Wang, Bruce H. Mitlak, Dan Mellstrom, Erik S. Oefjord, Ewa Marcinowska-Suchowierska, Jorma Salmi, Henk Mulder, Johan Halse, and Andrzej Z. Sawicki

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ABSTRACT

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 µg 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-µg and 40-µg parathyroid hormone groups; the respective relative risks of fracture in the 20-µg and 40-µg 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 0.86]). As compared with placebo, the 20-µg and 40-µg 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 femoral neck; the 40-µg dose decreased bone mineral density at the shaft of the radius by 2 more percentage points. Both doses increased total-body bone mineral by 2 to 4 more percentage points than did placebo. Parathyroid hormone had only minor side effects (occasional nausea and headache).

Conclusions Treatment of postmenopausal osteoporosis with parathyroid hormone (1-34) decreases the risk of vertebral and nonvertebral fractures; increases vertebral, femoral, and total-body bone mineral density; and is well tolerated. The 40-µg dose increased bone mineral density more than the 20-µg dose but had similar effects on the risk of fracture and was more likely to have side effects.


Source Information

From Massachusetts General Hospital and Harvard Medical School, Boston (R.M.N.); the University of California, San Francisco (C.D.A., H.K.G.); Fundación de Investigaciones Metabólicas, Buenos Aires, Argentina (J.R.Z.); the University of Western Australia and Sir Charles Gairdner Hospital, Perth, Australia (R.P.); Eli Lilly, Indianapolis (G.A.G., O.W., B.H.M.); Polycliniques Universitaires L. Brull, Liege, Belgium (J.-Y.R.); St. Joseph's Health Center, London, Ont., Canada (A.B.H.); Aarhus Amtssygehus, Aarhus, Denmark (E.F.E.); and Rambam Medical Center, Haifa, Israel (S.I.-S.).

Other authors were Dan Mellström, Department of Geriatrics, University of Göteborg, Göteborg, Sweden; Erik S. Oefjord, Bergen Osteoporosesenter, Paradis, Norway; Ewa Marcinowska-Suchowierska, Klinika Chorob Wewnetrznych, Warsaw, Poland; Jorma Salmi, Koskiklinikka, Tampere, Finland; Henk Mulder, Medisch Onderzoekscentrum Gcp, De Bilt, the Netherlands; Johan Halse, Betanien Med Lab, Oslo, Norway; and Andrzej Z. Sawicki, Warszawskie Centrum Osteoporozy, Warsaw, Poland.

Address reprint requests to Dr. Mitlak at Eli Lilly, Inc., Lilly Corporate Center, Indianapolis, IN 46285-2680, or at b.mitlak{at}lilly.com.

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