The Efficacy and Tolerability of Risedronate Once a week for the Treatment of Postmenopausal Osteoporosis

Abstract

This study evaluated the efficacy and tolerability of risedronate once a week (35 mg and 50 mg) compared with risedronate 5 mg once daily in women with osteoporosis. We conducted a randomized, double-blind, active-controlled, 2-year study; the primary efficacy assessment was performed after 1 year. Subjects were women aged 50 years or older who had been postmenopausal for at least 5 years, with either a bone mineral density (BMD) T-score of -2.5 or lower (lumbar spine or proximal femur) or a T-score lower than -2 and at least one prevalent vertebral fracture. Subjects received risedronate 5 mg once daily, 35 mg once a week or 50 mg once a week. All subjects also received 1 g daily of elemental calcium supplementation and supplemental vitamin D if the baseline serum levels were low. The primary efficacy measure was percent change in lumbar spine BMD at 12 months. A total of 1,456 women were randomized and received medication; 1,209 (83%) women completed 12 months. The mean percent change (SE) in lumbar spine BMD after 12 months was 4.0% (0.2%) in the 5 mg daily group, 3.9% (0.2%) in the 35 mg group, and 4.2% (0.2%) in the 50 mg group; each once-a-week treatment was determined to be as effective as the daily treatment. Outcomes of the secondary efficacy measurements and safety assessments were also similar in all 3 groups after 12 months. Risedronate 35 mg and 50 mg once a week provide the same efficacy and safety as the daily 5 mg regimen; therefore, the lower dose, 35 mg once a week, is considered optimal for women with postmenopausal osteoporosis who desire a once-a-week regimen.

Canadian Consensus Conference on Osteoporosis, 2006 Update

“…Once weekly alendronate (70 mg) and risedronate (35 mg) have been found to be equivalent to daily dosing at the lumbar spine, hip, and total body BMD. [113][114][115] Increasing age and the presence of non-vertebral fractures have been found to be independent predictors of adherence in postmenopausal women. 116 To minimize the risk for esophagitis, patients must take bisphosphonates on an empty stomach with a full glass of water, then remain upright and avoid food, beverage, and other medications for 30 minutes.…”

Bone mineral density measurements in post-menopausal women: When and which areas should be measured?

“…The increased risk of fracture in these menopausal women with widespread bone pain emphasises the need for regular BMD measurements. Brown et al (2002) stated that after the start of osteoporosis treatment, annual BMD measurements are necessary, whereas according to Lewiecki (2008), the measurements are necessary at intervals of one or two years. Bonnick (2005) recommended that no more than 20 months should pass between measurements, which are absolutely necessary once a year.…”

Osteoporosis inducida por glucocorticoides

“…Dado su mecanismo de acción, se podría considerar también efectivo en pacientes tratados con glucocorticoides 7 . Lo mismo sucedería con el risedronato en comprimido semanal de 35 mg 46 , disponible en el mercado muy recientemente. La ventaja fundamental sería una mayor adherencia de los pacientes al tratamiento frente a los regímenes diarios, más aún en estos pacientes multimedicados.…”