One Year of Alendronate after One Year of Parathyroid Hormone (184) for Osteoporosis
Dennis M. Black, Ph.D., John P. Bilezikian, M.D., Kristine E. Ensrud, M.D., M.P.H., Susan L. Greenspan, M.D., Lisa Palermo, M.A., Trisha Hue, M.A., Thomas F. Lang, Ph.D., Joan A. McGowan, Ph.D., Clifford J. Rosen, M.D., for the PaTH Study Investigators
Background Since the use of parathyroid hormone as a treatmentfor osteoporosis is limited to two years or less, the questionof whether antiresorptive therapy should follow parathyroidhormone therapy is important. We previously reported resultsafter the first year of this randomized trial comparing theuse of full-length parathyroid hormone (184) alone, alendronatealone, or both combined. In the continuation of this trial,we asked whether antiresorptive therapy is required to maintaingains in bone mineral density after one year of therapy withparathyroid hormone (184).
Methods In the data reported here, women who had received parathyroidhormone (184) monotherapy (100 µg daily) in year1 were randomly reassigned to one additional year with eitherplacebo (60 subjects) or alendronate (59 subjects). Subjectswho had received combination therapy in year 1 received alendronatein year 2; those who had received alendronate monotherapy inyear 1 continued with alendronate in year 2. Bone mineral densityat the spine and hip was assessed with the use of dual-energyx-ray absorptiometry and quantitative computed tomography (CT).
Results Over two years, alendronate therapy after parathyroidhormone therapy led to significant increases in bone mineraldensity in comparison with the results for placebo after parathyroidhormone therapy, a difference particularly evident for bonemineral density in trabecular bone at the spine on quantitativeCT (an increase of 31 percent in the parathyroid hormonealendronategroup as compared with 14 percent in the parathyroid hormoneplacebogroup). During year 2, subjects receiving placebo lost substantialbone mineral density.
Conclusions After one year of parathyroid hormone (184),densitometric gains appear to be maintained or increased withalendronate but lost if parathyroid hormone is not followedby an antiresorptive agent. These results have clinical implicationsfor therapeutic choices after the discontinuation of parathyroidhormone.
Source Information
From the Departments of Epidemiology and Biostatistics (D.M.B., L.P., T.H.) and Radiology (T.F.L.), University of California, San Francisco; the Department of Medicine, College of Physicians and Surgeons, Columbia University, New York (J.P.B.); the Departments of Medicine and Epidemiology, Minneapolis Veterans Affairs Medical Center and University of Minnesota, Minneapolis (K.E.E.); the University of Pittsburgh Medical Center, Pittsburgh (S.L.G.); the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health, Bethesda, Md. (J.A.M.); and the Maine Center for Osteoporosis Research, St. Joseph Hospital, Bangor (C.J.R.).
Address reprint requests to Dr. Black at the University of California, San Francisco, 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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