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
Background Once-daily injections of parathyroid hormone or itsamino-terminal fragments increase bone formation and bone masswithout causing hypercalcemia, but their effects on fracturesare unknown.
Methods We randomly assigned 1637 postmenopausal women withprior vertebral fractures to receive 20 or 40 µg of parathyroidhormone (1-34) or placebo, administered subcutaneously by thewomen daily. We obtained vertebral radiographs at base lineand at the end of the study (median duration of observation,21 months) and performed serial measurements of bone mass bydual-energy x-ray absorptiometry.
Results New vertebral fractures occurred in 14 percent of thewomen in the placebo group and in 5 percent and 4 percent, respectively,of the women in the 20-µg and 40-µg parathyroidhormone groups; the respective relative risks of fracture inthe 20-µg and 40-µg groups, as compared with theplacebo 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 fracturesoccurred in 6 percent of the women in the placebo group andin 3 percent of those in each parathyroid hormone group (relativerisk, 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, the20-µg and 40-µg doses of parathyroid hormone increasedbone mineral density by 9 and 13 more percentage points in thelumbar spine and by 3 and 6 more percentage points in the femoralneck; the 40-µg dose decreased bone mineral density atthe shaft of the radius by 2 more percentage points. Both dosesincreased total-body bone mineral by 2 to 4 more percentagepoints than did placebo. Parathyroid hormone had only minorside effects (occasional nausea and headache).
Conclusions Treatment of postmenopausal osteoporosis with parathyroidhormone (1-34) decreases the risk of vertebral and nonvertebralfractures; increases vertebral, femoral, and total-body bonemineral density; and is well tolerated. The 40-µg doseincreased bone mineral density more than the 20-µg dosebut had similar effects on the risk of fracture and was morelikely 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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