The Effects of Parathyroid Hormone and Alendronate Alone or in Combination in Postmenopausal Osteoporosis
Dennis M. Black, Ph.D., Susan L. Greenspan, M.D., Kristine E. Ensrud, M.D., M.P.H., Lisa Palermo, M.A., Joan A. McGowan, Ph.D., Thomas F. Lang, Ph.D., Patrick Garnero, Ph.D., Mary L. Bouxsein, Ph.D., John P. Bilezikian, M.D., Clifford J. Rosen, M.D., for the PaTH Study Investigators
Background Parathyroid hormone increases bone strength primarilyby stimulating bone formation, whereas antiresorptive drugsreduce bone resorption. We conducted a randomized, double-blindclinical study of parathyroid hormone and alendronate to testthe hypothesis that the concurrent administration of the twoagents would increase bone density more than the use of eitherone alone.
Methods A total of 238 postmenopausal women (who were not usingbisphosphonates) with low bone mineral density at the hip orspine (a T score of less than –2.5, or a T score of lessthan –2.0 with an additional risk factor for osteoporosis)were randomly assigned to daily treatment with parathyroid hormone(1–84) (100 µg; 119 women), alendronate (10 mg;60 women), or both (59 women) and were followed for 12 months.Bone mineral density at the spine and hip was assessed by dual-energyx-ray absorptiometry and quantitative computed tomography. Markersof bone turnover were measured in fasting blood samples.
Results The bone mineral density at the spine increased in allthe treatment groups, and there was no significant differencein the increase between the parathyroid hormone group and thecombination-therapy group. The volumetric density of the trabecularbone at the spine increased substantially in all groups, butthe increase in the parathyroid hormone group was about twicethat found in either of the other groups. Bone formation increasedmarkedly in the parathyroid hormone group but not in the combination-therapygroup. Bone resorption decreased in the combination-therapygroup and the alendronate group.
Conclusions There was no evidence of synergy between parathyroidhormone and alendronate. Changes in the volumetric density oftrabecular bone, the cortical volume at the hip, and levelsof markers of bone turnover suggest that the concurrent useof alendronate may reduce the anabolic effects of parathyroidhormone. Longer-term studies of fractures are needed to determinewhether and how antiresorptive drugs can be optimally used inconjunction with parathyroid hormone therapy.
Source Information
From the Departments of Epidemiology and Biostatistics (D.M.B., L.P.) and Radiology (T.F.L.), University of California, San Francisco, San Francisco; the University of Pittsburgh Medical Center, Pittsburgh (S.L.G.); the Departments of Medicine and Epidemiology, Minneapolis Veterans Affairs Medical Center and University of Minnesota, Minneapolis (K.E.E.); the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Md. (J.A.M.); Synarc, Lyons, France (P.G.); the Department of Orthopedic Surgery, Beth Israel Deaconess Medical Center, Boston (M.L.B.); the Department of Medicine, College of Physicians and Surgeons, Columbia University, New York (J.P.B.); the Maine Center for Osteoporosis Research, St. Joseph Hospital, Bangor (C.J.R.); and the Jackson Laboratory, Bar Harbor, Me. (C.J.R.). This article was published at www.nejm.org on September 20, 2003.
Address reprint requests to Dr. Black at the University of California, San Francisco, Coordinating Center, 74 New Montgomery St., Suite 600, San Francisco, CA 94105, or at dblack{at}psg.ucsf.edu.
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