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The Journal of Clinical Endocrinology & Metabolism Vol. 88, No. 11 5212-5220
Copyright © 2003 by The Endocrine Society

Efficacy and Safety of Human Parathyroid Hormone-(1–84) in Increasing Bone Mineral Density in Postmenopausal Osteoporosis

Anthony B. Hodsman, David A. Hanley, Mark P. Ettinger, Michael A. Bolognese, John Fox, Anna J. Metcalfe and Robert Lindsay

Department of Medicine, Lawson Health Research Institute, University of Western Ontario (A.B.H.), London, Ontario, Canada N6A 4V2; Department of Medicine, University of Calgary (D.A.H.), Calgary, Alberta, Canada T2N 4N1; Regional Osteoporosis Center of South Florida and Radiant Research (M.P.E.), Stuart, Florida 34996; Bethesda Health Research (M.A.B.), Bethesda, Maryland 20817; NPS Pharmaceuticals, Inc. (J.F., A.J.M.), Salt Lake City, Utah 84108; and Regional Bone Center, Helen Hayes Hospital (R.L.), West Haverstraw, New York 10993

Address all correspondence and requests for reprints to: Anthony B. Hodsman, M.D., Department of Medicine, St. Joseph’s Health Center, Room F-215, 268 Grosvenor Street, London, Ontario, Canada N6A 4V2. E-mail: anthony.hodsman{at}sjhc.london.on.ca.

Daily sc injections of N-terminal analogs of PTH increase bone mass and decrease fractures in osteoporotic women. We investigated the efficacy and safety of human PTH-(1–84) (full-length PTH) in the treatment of postmenopausal osteoporosis in a double-blind, placebo-controlled study. The women (n = 50–53/group) self-administered PTH (50, 75, or 100 µg) or placebo by daily sc injection for 12 months. PTH treatment induced time- and dose-related increases in lumbar spine bone mineral density (BMD). The 100-µg dose increased BMD significantly at 3 months (+2.0%) and 12 months (+7.8%). BMD underestimated the anabolic effect of PTH in lumbar spine (bone mineral content, +10.0%) because bone area increased significantly (+2.0%). A nonsignificant decrease (-0.9%) in total hip BMD occurred during the first 6 months with the 100-µg dose, but this trend reversed (+1.6%) during the second 6 months. Bone turnover markers increased during the first half of the study and were maintained at elevated levels during the second 6 months. Protocol compliance was excellent (95–98%), and treatment was generally safe and well tolerated. Dose-related incidences of transient hypercalcemia occurred, but only one patient (100-µg group) was withdrawn because of repeated hypercalcemia. Thus, full-length PTH was efficacious and safe over 12 months.

Abbreviations: AE, Adverse event; BMC, bone mineral content; BMD, bone mineral density; CV, coefficient of variation; DXA, dual energy x-ray absorptiometry; ITT, intention to treat; NTx, N-terminal collagen telopeptide; QCT, quantitative computed tomography.




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