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Previous Volume 339:292-299 July 30, 1998 Number 5 Next

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ABSTRACT

Background Osteoporosis is a common complication of long-term glucocorticoid therapy for which there is no well-proved preventive or restorative treatment.

Methods We carried out two 48-week, randomized, placebo-controlled studies of two doses of alendronate in 477 men and women, 17 to 83 years of age, who were receiving glucocorticoid therapy. The primary end point was the difference in the mean percent change in lumbar-spine bone density from base line to week 48 between the groups. Secondary outcomes included changes in bone density of the hip, biochemical markers of bone turnover, and the incidence of new vertebral fractures.

Results The mean (±SE) bone density of the lumbar spine increased by 2.1±0.3 percent and 2.9±0.3 percent, respectively, in the groups that received 5 and 10 mg of alendronate per day (P<0.001) and decreased by 0.4±0.3 percent in the placebo group. The femoral-neck bone density increased by 1.2±0.4 percent and 1.0±0.4 percent in the respective alendronate groups (P<0.01) and decreased by 1.2±0.4 percent in the placebo group (P<0.01). The bone density of the trochanter and total body also increased significantly in the patients treated with alendronate. There were proportionally fewer new vertebral fractures in the alendronate groups (overall incidence, 2.3 percent) than in the placebo group (3.7 percent) (relative risk, 0.6; 95 percent confidence interval, 0.1 to 4.4). Markers of bone turnover decreased significantly in the alendronate groups (P<0.001). There were no differences in serious adverse effects among the three groups, but there was a small increase in nonserious upper gastrointestinal effects in the group receiving 10 mg of alendronate.

Conclusions Alendronate increases bone density in patients receiving glucocorticoid therapy.

Source Information

From the Division of Rheumatology, Department of Internal Medicine, and the Department of Preventive Medicine and Environmental Health, University of Iowa College of Medicine, Iowa City (K.G.S.); the Bone Research Center, West Reading, Pa. (R.E.); Northwestern University, Chicago (T.J.S.); the Centre Hospitalier Universitaire de Quebec, Sainte-Foy, Que., Canada (J.P.B.); Servicio de Endocrinologia, Hospital 12 de Octubre, Madrid (F.H.); University Hospital, Ghent, Belgium (S.G.); Osteoporosecentret Kommunchopitalet, Copenhagen, Denmark (G.T.); Beilison Medical Center, Petach-Tikva, Israel (U.A.L.); Hôpital Edouard Herriot, Lyons, France (P.D.D.); and Merck Research Laboratories, Rahway, N.J. (M.-P.M., M.C., A.G.D.). Other authors were Nancy Lane, M.D. (University of California at San Francisco, San Francisco); Ricardo Correa-Rotter, M.D. (Instituto Nacional de la Nutricion, Salvador Zubiran, Mexico); Melissa Yanover, M.D. (Western Nephrology and Metabolic Bone Disease, Lakewood, Colo.); Rene Westhovens, M.D. (Universitair Ziekenhuisen Leuven, Pellenberg, Belgium); Sol Epstein, M.D. (Albert Einstein Medical Center, Philadelphia); Jonathan D. Adachi, M.D. (St. Joseph's Hospital, McMaster University, Hamilton, Ont., Canada); Patrice Poubelle, M.D., D.Sc. (Centre Hospitalier Universitaire de Quebec, Sainte-Foy, Que., Canada); Jose Melo-Gomes, M.D. (Hospital Militar Principal, Unidade de Reumatologia, Lisbon, Portugal); and Jose A. Rodriguez-Portales, M.D. (Universidad Catolica de Chile, Santiago, Chile).Presented in part at the National Scientific Meeting of the American College of Rheumatology, Washington, D.C., November 8–12, 1997.

Address reprint requests to Dr. Saag at the Division of Rheumatology, Department of Internal Medicine, University of Iowa Hospitals and Clinics, 200 Hawkins Dr., Iowa City, IA 52242-1081.

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