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Effects of Prasterone on Bone Mineral Density in Women with Active Systemic Lupus Erythematosus Receiving Chronic Glucocorticoid Therapy JORGE SÁNCHEZ-GUERRERO, HILDA E. FRAGOSO-LOYO, C. MICHAEL NEUWELT, DANIEL J. WALLACE, ELLEN M. GINZLER, YVONNE R.S. SHERRER, HARRIS H. MCILWAIN, PAMELA G. FREEMAN, CYNTHIA ARANOW, MICHELLE A. PETRI, ATUL A. DEODHAR, ELLEN BLANTON, SUSAN MANZI, ARTHUR KAVANAUGH, JEFFREY R. LISSE, ROSALIND RAMSEY-GOLDMAN, JAMES D. MCKAY, ALAN J. KIVITZ, PHILIP J. MEASE, ANNE E. WINKLER, LESLIE E. KAHL, ALBERT H. LEE, RICHARD A. FURIE, C. VIBEKE STRAND, LILLIAN LOU, MUMTAZ AHMED, BETTY QUARLES, and KENNETH E. SCHWARTZ
ABSTRACT. Methods. 155 patients with SLE received 200 mg/day prasterone or placebo for 6 months in a double-blind phase. Subsequently, 114 patients were re-randomized to receive 200 or 100 mg/day prasterone for 12 months in an open-label phase. Primary efficacy endpoints were changes in BMD at the lumbar spine (L-spine) from baseline to Month 6 and maintenance of BMD from Month 6 to 18 for patients who received prasterone during the double-blind phase. Results. In the double-blind phase, there was a trend for a small gain in BMD at the L-spine for patients who received 200 mg/day prasterone for 6 months versus a loss in the placebo group (mean ± SD, 0.003 ± 0.035 vs –0.005 ± 0.053 g/cm2, respectively; p = 0.293 between groups). In the open-label phase, there was dose-dependent increase in BMD at the L-spine at Month 18 between patients who received 200 versus 100 mg/day prasterone (p = 0.021). For patients who received 200 mg/day prasterone for 18 months, the L-spine BMD gain was 1.083 ± 0.512% (p = 0.042). There was no overall change in BMD at the total hip over 18 months with 200 mg/day prasterone treatment. The safety profile reflected the weak androgenic properties of prasterone. Conclusion. This study suggests prasterone 200 mg/day may offer mild protection against bone loss in women with SLE receiving glucocorticoids. (ClinicalTrials.gov Identifiers NCT00053560 and NCT00082511) (First Release July 15 2008; J Rheumatol 2008;35:1567–75) Key Indexing Terms:
DEHYDROEPIANDROSTERONE
From the Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, México, D.F., México; University of California, San Francisco, CA; Cedars-Sinai Medical Center/David Geffen School of Medicine at UCLA, Los Angeles, CA; State University of New York Downstate Medical Center, Brooklyn, NY; The Arthritis Center, Fort Lauderdale, FL; Tampa Medical Group, PA, Tampa, FL; Rheumatology Associates of Central Florida, Orlando, FL; The Feinstein Institute for Medical Research, Manhasset, NY; Johns Hopkins University School of Medicine, Baltimore, MD; Oregon Health and Science University, Portland, OR; Desert Oasis Health Care, Palm Springs, CA; University of Pittsburgh, Pittsburgh, PA; University of California, San Diego, CA; University of Arizona Arthritis Center, Tucson, AZ; Northwestern University Feinberg School of Medicine, Chicago, IL; Oklahoma Center for Arthritis Therapy, Tulsa, OK; Altoona Arthritis & Osteoporosis Center, Duncansville, PA; Seattle Rheumatology Associates, Seattle, WA; St Johns Physicians & Clinics, Springfield, MO; Washington University School of Medicine, St. Louis, MO; NDC Medical Center, Norfolk, VA; North Shore LIJ Health System, Lake Success, NY; Stanford University School of Medicine, Stanford, CA; Genelabs Technologies, Inc., Redwood City, CA, USA. Funded by a grant from Genelabs Technologies, Inc. Dr. Strand has acted as a consultant to Genelabs Technologies. J. Sánchez-Guerrero, MD; H.E. Fragoso-Loyo, MD, Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; C.M. Neuwelt, MD, University of California; D.J. Wallace, MD, Cedars-Sinai Medical Center/David Geffen School of Medicine at UCLA; E.M. Ginzler, MD, MPH, State University of New York Downstate Medical Center; Y.R. S. Sherrer, MD, The Arthritis Center, Fort Lauderdale, FL; H.H. McIlwain, MD, Tampa Medical Group, PA, Tampa, FL; P.G. Freeman, MD, Rheumatology Associates of Central Florida; C. Aranow, MD, The Feinstein Institute for Medical Research; M.A. Petri, MD, MPH, Johns Hopkins University School of Medicine; A.A. Deodhar, MD, Oregon Health and Science University; E. Blanton, MD, Desert Oasis Health Care; S. Manzi, MD, MPH, University of Pittsburgh; A. Kavanaugh, MD, University of California, San Diego; J.R. Lisse, MD, University of Arizona Arthritis Center; R. Ramsey-Goldman, MD, DrPH, Northwestern University Feinberg School of Medicine; J.D. McKay, DO, Oklahoma Center for Arthritis Therapy; A.J. Kivitz, MD, Altoona Arthritis & Osteoporosis Center; P.J. Mease, MD, Seattle Rheumatology Associates; A.E. Winkler, MD, PhD, St Johns Physicians & Clinics; L.E. Kahl, MD, Washington University School of Medicine; A.H. Lee, MD, NDC Medical Center; R.A. Furie, MD, North Shore LIJ Health System; C.V. Strand, MD, Stanford University School of Medicine; L. Lou, PhD; M. Ahmed, MD, PhD; B. Quarles, BS, formerly with Genelabs Technologies; K.E. Schwartz, MD, Genelabs Technologies, Inc. Address reprints to Dr. J. Sánchez-Guerrero, Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición, S.Z. Vasco de Quiroga 15, Col. Sección XVI, Deleg. Tlalpan, 14000 México, D.F. E-mail: jsanchezguerrero7@gmail.com Accepted for publication March 31, 2008. |
