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Randomized Trial of Once-Weekly Parathyroid Hormone (1-84) on Bone Mineral Density and Remodeling

San Francisco Coordinating Center (D.M.B., L.P.) and Departments of Epidemiology and Biostatistics (D.M.B., L.P.) and Radiology (D.C.N., S.M.), University of California, San Francisco (UCSF), San Francisco, California 94107; Department of Orthopedics (M.L.B., E.R.), Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts 02215; The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (J.A.M.), National Institutes of Health, Bethesda, Maryland 20894; and Maine Center for Osteoporosis Research (C.J.R.), St. Joseph Hospital, Bangor, Maine 04401

Address all correspondence and requests for reprints to: Dennis M. Black, Ph.D., University of California, San Francisco, Department of Epidemiology and Biostatistics, 185 Berry Street, Suite 5700, San Francisco, CA 94107. E-mail: dblack{at}psg.ucsf.edu.

Context: Daily PTH administration increases bone mineral density (BMD) and reduces fracture risk. However, cost and compliance significantly limit clinical use.

Objective: Our objective was to determine whether less frequent PTH administration increases lumbar spine BMD.

Participants, Design, and Setting: Fifty postmenopausal women ages 45–70 yr with femoral neck BMD T-score between –1.0 and –2.0 participated in a double-blind, randomized, placebo-controlled trial at St. Joseph Hospital, Bangor, ME.

Intervention: Subjects received sc injections of daily PTH(1-84) (100 µg) or placebo for 1 month, followed by weekly injections (PTH or placebo) for 11 months.

Outcomes: Change in lumbar spine dual-energy x-ray absorptiometry areal BMD (primary) was assessed. Secondary outcomes included volumetric BMD at spine and hip by quantitative computed tomography, trabecular bone microarchitecture by magnetic resonance imaging of distal radius, and biochemical bone turnover markers.

Results: At 12 months, lumbar spine areal BMD increased 2.1% in PTH-treated women compared with placebo (P = 0.03). Vertebral trabecular volumetric BMD increased 3.8% in PTH-treated women compared with placebo group (P = 0.08). PTH-treated women also had higher distal radial trabecular bone volume, number, and thickness compared with placebo-treated women (P < 0.04). After 1 month of daily PTH, N-terminal propeptide of type I collagen (P1NP) was markedly increased compared with placebo (P < 0 .0001), and a difference persisted, although lessened, throughout the study. Bone resorption indices were unchanged in PTH-treated women and were reduced in the placebo group.

Conclusion: Once-weekly PTH after 1 month of daily treatment increases spine BMD, radial trabecular bone, and bone formation markers in postmenopausal women. These results suggest that less frequent alternatives to daily PTH dosing for 2 yr could be effective. Additional studies are required to define the optimal frequency of PTH administration.