Daily Oral Pamidronate in Women and Men With Osteoporosis: A 3‐Year Randomized Placebo‐Controlled Clinical Trial With a 2‐Year Open Extension

The efficacy and safety of oral pamidronate was examined in a double‐blind, placebo‐controlled trial in women and men with established osteoporosis. Seventy‐eight postmenopausal women and 23 men with at least one prevalent vertebral fracture were randomized separately to 150 mg/day of pamidronate or placebo for 3 years followed by 150 mg/day of pamidronate for an additional 2 years. In addition, all patients received 400 U/day of cholecalciferol and 500 mg/day of elemental calcium. Pamidronate increased significantly bone mineral density of the lumbar spine (LS‐BMD) and of the femoral neck (FN‐BMD). The total increase in BMD of the spine after 5 years of treatment was 14.3%. Lateral spine radiographs were obtained at baseline and after 3 years of treatment. Fractures of previously normal vertebrae occurred in 15 of 45 patients treated with placebo (33.3%) and in 5 of 46 patients treated with pamidronate (11%). The relative risk was 0.33 (95% CI, 0.14‐0.77). Treatment was well tolerated and there was no difference in gastrointestinal toxicity between pamidronate and placebo‐treated patients. One hundred fifty milligrams daily of pamidronate is an effective and safe treatment of women and men with established osteoporosis.