Effects of prasterone on bone mineral density in women with active systemic lupus erythematosus receiving chronic glucocorticoid therapy.
J Rheumatol
; 35(8): 1567-75, 2008 Aug.
Article
em En
| MEDLINE
| ID: mdl-18634158
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. (ClinicalTrials.gov Identifiers NCT00053560 and NCT00082511).
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Osteoporose
/
Desidroepiandrosterona
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Conservadores da Densidade Óssea
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Glucocorticoides
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Lúpus Eritematoso Sistêmico
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Female
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Humans
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Middle aged
Idioma:
En
Revista:
J Rheumatol
Ano de publicação:
2008
Tipo de documento:
Article