Sánchez-guerrero J et al. - This study suggests prasterone 200 mg/day may offer mild protection against bone loss in women with systemic lupus erythematosus (SLE) receiving glucocorticoids. Methods
Study to assess prevention of BMD loss and durability of the response during treatment with prasterone in women with SLE receiving chronic glucocorticoids
155 pts with SLE received 200 mg/day prasterone or placebo for 6 mos in a double-blind phase
Subsequently, 114 pts were re-randomized to receive 200 or 100 mg/day prasterone for 12 mos in an open-label phase
Primary efficacy endpoints were changes in BMD at the lumbar spine from baseline to Month 6 and maintenance of BMD from Month 6 to 18 for pts 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 pts who received 200 mg/day prasterone for 6 mos vs a loss in the placebo group
In the open-label phase, there was dose-dependent increase in BMD at the L-spine at Month 18 between pts who received 200 vs 100 mg/day prasterone
For pts who received 200 mg/day prasterone for 18 mos, the L-spine BMD gain was 1.083 ± 0.512%
There was no overall change in BMD at the total hip over 18 mos with 200 mg/day prasterone treatment
The safety profile reflected the weak androgenic properties of prasterone
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