Osteoporotic postmenopausal women at higher risk for fracture who took Actonel/Optinate (risedronate sodium) 5 mg daily had a 62 per cent reduction of new vertebral fractures and a 90 per cent reduction of multiple new vertebral fractures at one year, when compared to the control group. The results, published in the February issue of the Journal of Clinical Endocrinology and Metabolism, demonstrate a clinically significant benefit for high risk patients taking Actonel/Optinate within the first year of therapy.
Postmenopausal women, who no longer naturally produce estrogen, are at risk for developing osteoporosis—a skeletal disorder characterized by reduced bone strength. This reduced bone strength predisposes these women to an increased risk of fracture. Approximately 40 per cent of women will suffer an osteoporotic fracture in their lifetimes. Studies show that among postmenopausal women who have suffered a bone fracture, one in five will suffer another fracture within one year, potentially leading to more fractures, called a fracture cascade.
“The ultimate goal of osteoporosis treatment is to prevent fractures. Providing rapid fracture protection is critical to a patient group that, if untreated, is likely to fracture soon,” said Nelson Watts, MD, lead author and Director UC Bone Health Center, University of Cincinnati, Ohio. “In this analysis, significant reductions in fracture risk were seen at one year with Actonel and underscore the importance of early identification and treatment of patients at high risk for fracture.”
The pooled analysis of data from two randomized, double-blind studies (VERT-Multinational and VERT-North America) assessed the risk of women with postmenopausal osteoporosis (PMO) with at least one confirmed vertebral fracture and at higher risk of sustaining new and multiple vertebral fractures. A post hoc statistical comparison was performed based on 3,684 PMO women treated with Actonel/Optinate (risedronate sodium) 2.5 or 5 mg/d. All women received 1,000 mg/d calcium and up to 500 IU/d of vitamin D. In the overall population, the risk of new vertebral fractures was reduced by 62percent (P<0.001) and the risk of multiple new vertebral fractures was reduced by 90 per cent (P<0.001) with Actonel/Optinate 5 mg/d at one year versus the control group.
The subgroup analysis of the high risk patients [PMO women =70 years of age, PMO women with low BMD at the femoral neck (FN-BMD) (T-scores of = -2.5 Standard Deviation), PMO women with = 2 prevalent vertebral fractures (the median number of prevalent fractures within the patient group)] demonstrated consistent efficacy results at one year of therapy with Actonel/Optinate.
The significant reduction in risk of new and multiple vertebral fractures with Actonel/Optinate is consistent with previously reported clinical results observed in PMO women with and without existing fractures.
Actonel/Optinate (risedronate sodium tablets) is a bisphosphonate marketed by the Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals and Aventis) currently approved in 82 countries worldwide. Actonel 35 mg Once a Week and Actonel 5 mg daily are indicated for the treatment of osteoporosis in postmenopausal women. Actonel 5 mg is also indicated for the prevention of osteoporosis in postmenopausal women and the management of glucocorticoid-induced osteoporosis (GIO)