Effect of calcitriol on bone mineral density in premenopausal Chinese women taking chronic steroid therapy. A randomized, double blind, placebo controlled study.

Abstract

To study the effect of chronic steroid therapy on bone mineral density (BMD) in premenopausal women with normal menstrual cycles and its treatment. A double blind placebo controlled study to evaluate 81 premenopausal women with systemic lupus erythematosus (SLE), aged 31.1 +/- 6 years, taking chronic steroid therapy, with a mean cumulative prednisone dose of 28 +/- 16.2 g. They were randomly allocated to 3 groups: Group 1: 0.5 microg calcitriol and 1200 mg calcium daily; Group 2: 1,200 mg calcium and placebo calcitriol; and Group 3: both placebo calcitriol and placebo calcium. Baseline T score at the lumbar spine was > -1 in 56.8% and < -2.5 in 3.7% of the patients. At the end of 2 years, patients in the calcitriol group exhibited a significant increase of 2.1 +/- 2.4% in BMD at the lumbar spine compared to baseline value (p < 0.05). This change was not significantly different from the respective change in either calcium or placebo group (0.4 +/- 2.9% and 0.3 +/- 3.5%, respectively). No significant changes were observed in any treatment group in BMD at the hip or radius. Alkaline phosphatase increased both in the placebo (baseline: 57.5 +/- 17.5 IU/I; year 2: 60.9 +/- 15.3 IU/A) and the calcium group (baseline: 53.6 +/- 16.6 IU/I; year 2: 59.0 +/- 22.8 IU/1), but this increase reached statistical significance only in the calcium group, while the same variable remained stable in the calcitriol group (baseline: 53.9 +/- 14.1 IU/I; year 2: 54.6 +/- 12.3 IU/I). Premenopausal women with SLE taking prolonged steroid therapy had lower BMD but showed no significant bone loss over the 2 year study period. The beneficial effect of calcitriol treatment in these premenopausal women was small, at least when it was instituted late in the course of steroid therapy.