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 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 & 8 others Leslie E. Kahl, Albert H. Lee, Richard A. Furie, C. Vibeke Strand, Lillian Lou, Mumtaz Ahmed, Betty Quarles, Kenneth E. Schwartz

Research output: Contribution to journalArticle

Abstract

Objective. To assess prevention of bone mineral density (BMD) loss and durability of the response during treatment with prasterone in women with systemic lupus erythematosus (SLE) receiving chronic glucocorticoids. 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/cm 2, 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.

Original languageEnglish (US)
Pages (from-to)1567-1575
Number of pages9
JournalJournal of Rheumatology
Volume35
Issue number8
StatePublished - Aug 2008

Fingerprint

Dehydroepiandrosterone
Systemic Lupus Erythematosus
Bone Density
Glucocorticoids
Spine
Therapeutics
Placebos
Hip
Maintenance
Safety
Bone and Bones

Keywords

  • Bone mineral density
  • Dehydroepiandrosterone
  • Osteoporosis
  • Prasterone
  • Systemic lupus erythematosus

ASJC Scopus subject areas

  • Rheumatology
  • Immunology

Cite this

Sánchez-Guerrero, J., Fragoso-Loyo, H. E., Neuwelt, C. M., Wallace, D. J., Ginzler, E. M., Sherrer, Y. R. S., ... Schwartz, K. E. (2008). Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy. Journal of Rheumatology, 35(8), 1567-1575.

Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy. / Sánchez-Guerrero, Jorge; Fragoso-Loyo, Hilda E.; Neuwelt, C. Michael; Wallace, Daniel J.; Ginzler, Ellen M.; Sherrer, Yvonne R S; McIlwain, Harris H.; Freeman, Pamela G.; Aranow, Cynthia; Petri, Michelle; Deodhar, Atul A.; Blanton, Ellen; Manzi, Susan; Kavanaugh, Arthur; Lisse, Jeffrey R.; Ramsey-Goldman, Rosalind; Mckay, James D.; Kivitz, Alan J.; Mease, Philip J.; Winkler, Anne E.; Kahl, Leslie E.; Lee, Albert H.; Furie, Richard A.; Strand, C. Vibeke; Lou, Lillian; Ahmed, Mumtaz; Quarles, Betty; Schwartz, Kenneth E.

In: Journal of Rheumatology, Vol. 35, No. 8, 08.2008, p. 1567-1575.

Research output: Contribution to journalArticle

Sánchez-Guerrero, J, Fragoso-Loyo, HE, Neuwelt, CM, Wallace, DJ, Ginzler, EM, Sherrer, YRS, McIlwain, HH, Freeman, PG, Aranow, C, Petri, M, Deodhar, AA, Blanton, E, Manzi, S, Kavanaugh, A, Lisse, JR, Ramsey-Goldman, R, Mckay, JD, Kivitz, AJ, Mease, PJ, Winkler, AE, Kahl, LE, Lee, AH, Furie, RA, Strand, CV, Lou, L, Ahmed, M, Quarles, B & Schwartz, KE 2008, 'Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy', Journal of Rheumatology, vol. 35, no. 8, pp. 1567-1575.
Sánchez-Guerrero J, Fragoso-Loyo HE, Neuwelt CM, Wallace DJ, Ginzler EM, Sherrer YRS et al. Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy. Journal of Rheumatology. 2008 Aug;35(8):1567-1575.
Sánchez-Guerrero, Jorge ; Fragoso-Loyo, Hilda E. ; Neuwelt, C. Michael ; Wallace, Daniel J. ; Ginzler, Ellen M. ; Sherrer, Yvonne R S ; McIlwain, Harris H. ; Freeman, Pamela G. ; Aranow, Cynthia ; Petri, Michelle ; Deodhar, Atul A. ; Blanton, Ellen ; Manzi, Susan ; Kavanaugh, Arthur ; Lisse, Jeffrey R. ; Ramsey-Goldman, Rosalind ; Mckay, James D. ; Kivitz, Alan J. ; Mease, Philip J. ; Winkler, Anne E. ; Kahl, Leslie E. ; Lee, Albert H. ; Furie, Richard A. ; Strand, C. Vibeke ; Lou, Lillian ; Ahmed, Mumtaz ; Quarles, Betty ; Schwartz, Kenneth E. / Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy. In: Journal of Rheumatology. 2008 ; Vol. 35, No. 8. pp. 1567-1575.
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abstract = "Objective. To assess prevention of bone mineral density (BMD) loss and durability of the response during treatment with prasterone in women with systemic lupus erythematosus (SLE) receiving chronic glucocorticoids. 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/cm 2, 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.",
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T1 - Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy

AU - Sánchez-Guerrero, Jorge

AU - Fragoso-Loyo, Hilda E.

AU - Neuwelt, C. Michael

AU - Wallace, Daniel J.

AU - Ginzler, Ellen M.

AU - Sherrer, Yvonne R S

AU - McIlwain, Harris H.

AU - Freeman, Pamela G.

AU - Aranow, Cynthia

AU - Petri, Michelle

AU - Deodhar, Atul A.

AU - Blanton, Ellen

AU - Manzi, Susan

AU - Kavanaugh, Arthur

AU - Lisse, Jeffrey R.

AU - Ramsey-Goldman, Rosalind

AU - Mckay, James D.

AU - Kivitz, Alan J.

AU - Mease, Philip J.

AU - Winkler, Anne E.

AU - Kahl, Leslie E.

AU - Lee, Albert H.

AU - Furie, Richard A.

AU - Strand, C. Vibeke

AU - Lou, Lillian

AU - Ahmed, Mumtaz

AU - Quarles, Betty

AU - Schwartz, Kenneth E.

PY - 2008/8

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N2 - Objective. To assess prevention of bone mineral density (BMD) loss and durability of the response during treatment with prasterone in women with systemic lupus erythematosus (SLE) receiving chronic glucocorticoids. 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/cm 2, 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.

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KW - Bone mineral density

KW - Dehydroepiandrosterone

KW - Osteoporosis

KW - Prasterone

KW - Systemic lupus erythematosus

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