The effect of clodronate on bone mineral density and serum osteocalcin in postmenopausal women with osteopenia - a prospective, randomized, placebo-controlled study.

Background. The efficacy of bisphosphonates in treatment of established osteoporosis has been well-documented; less data have been published on their efficacy in the prophylaxis of postmenopausal bone loss in women with osteopenia. The aim of study was to evaluate the effect of clodronate on bone loss in early postmenopausal women with vertebral osteopenia. Materials and methods. Forty five women aged 52.3+/-3.8 yr with a lumbar spine (Spine) t-score between -1 and -2.5 SD received clodronate 400 mg/day or placebo for 12 months. Bone mineral density (BMD) was measured by DXA in Spine and femoral neck (Femur). Serum osteocalcin (OC) was assessed by RIA. BMD and OC were measured at the baseline, after 1 year of treatment and after further 1 and 2 years of follow-up. Results. BMD slightly decreased in clodronate group: Spine by 0.2% after 1 year (N.S.), 0.5% after 2 years (N.S.) and 0.9% after 3 years (P<0.05 vs. placebo group); Femur by 0.2%, 0.9% and 1.3% (N.S.). OC did not change in placebo group but significantly decreased in clodronate group (15.2%; P<0.05). Conclusions. Clodronate 400 mg daily given postmenopausal women with osteopenia is effective in decreasing OC but an effect on BMD is just detectable and its clinical significance is unclear.