Bisphosphonates and osteoporosis treatment in Italy.

A treatment against osteoporosis can be considered efficacious only when its beneficial effects on bone remodeling, bone mass, and osteoporotic fracture incidence are proven. As for any treatment, proven efficacy must be combined with proven safety. This review analyzes published data on efficacy and safety of alendronate, clodronate and etidronate, the bisphosphonates currently marketed in Italy for osteoporosis treatment. Different studies have shown that alendronate, clodronate and etidronate reduce bone turnover, and increase bone mineral density in postmenopausal osteoporotic patients. Prospective, double blind, multicenter studies reported a reduction in osteoporotic fracture incidence for alendronate and etidronate. Fracture incidence reduction by clodronate, on the other hand, was shown only in an open label study. Finally, a reduction in fracture incidence by etidronate was shown in a large retrospective postmarketing study. Postmarketing surveillance evidenced that osteomalacia, a suspected side effect of etidronate treatment, does not occur at the currently used dose regimens. Postmarketing surveillance of alendronate has recently raised some concern regarding possible severe esophageal damage during alendronate treatment, especially when the drug is not taken according to the manufacturer's instructions.