Alendronate/colecalciferol.

Abstract

Alendronate/colecalciferol 70 mg/2800 IU, a once-weekly tablet containing the bisphosphonate alendronate and colecalciferol (the precursor of the biologically active form of vitamin D), has been approved for the treatment of osteoporosis in women and for increasing bone mass in men with osteoporosis. The mean oral bioavailability of alendronate or colecalciferol is similar when administered alone or as one once-weekly tablet containing alendronate/colecalciferol 70 mg/2800 IU. In a 15-week, randomized, double-blind, multicenter study in patients with osteoporosis, the proportion of patients with serum 25-hydroxyvitamin D3 levels <15 ng/mL was significantly lower with alendronate/colecalciferol than with alendronate alone. Markers of bone turnover were not significantly different in recipients of alendronate/colecalciferol or alendronate alone. Alendronate is generally well tolerated in men and women with osteoporosis, with adverse events being mainly transient and associated with the upper gastrointestinal tract. The treatment-related adverse event profile of once-weekly alendronate/colecalciferol 70 mg/2800 IU was similar to that of once-weekly alendronate in the 15-week, double-blind study in patients with osteoporosis.