PREVENTION OF EARLY POSTMENOPAUSAL BONE LOSS WITH CYCLICAL ETIDRONATETHERAPY (A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY AND 1-YEAR FOLLOW-UP)

The objective of the study was to evaluate the effects of cyclical the rapy with etidronate and calcium on spinal and femoral bone loss in th e early post menopausal period. Fifty-four women, 53 +/- 2.8 yr old (m ean +/- SD) and 2.3 +/- 1.3 yr post menopause received oral doses of e ither 400 mg/day etidronate for 2 weeks followed by 500 mg/day element al calcium for 11 weeks, or placebo for 14 days followed by calcium fo r II weeks, repeated over a total of 24 months. A statistically signif icant increase in spinal bone mineral density (BMD) was observed after 6 months in the etidronate group. At 2 yr, the mean treatment differe nces in spinal and femoral neck BMD were +2.93% (P < 0.02) and 2.02% ( P < 0.03), respectively. Serum osteocalcin and urinary crosslaps/creat inine excretion were decreased signficantly by etidronate. Etidronate was well tolerated with a safety profile similar to that of placebo. T hirty-seven women participated in a l-yr open-label follow-up study. T welve months after treatment withdrawal, spinal BMD in the former etid ronate group decreased by 1.43% and serum osteocalcin and urinary cros sLaps returned to pretreatment values. In conclusion, cyclical etidron ate is an effective therapy for the prevention of both trabecular and cortical bone loss in the early menopause and has a good safety profil e.