Efficacy, Side Effects, Safety and Effects on Bone Turnover Markers of once a Week Sandoz Alendronate Sodium Trihydrate 70 mg
Abstract
This open trial study was carried out to evaluate safety, side effects and efficacy of once a week alendronate sodium trihydrate (Sandoz, Pyrmant, Australia) for inhibiting bone resorption and bone turnover in 35 postmenopausal osteoporotic patients. Serum beta crosslaps was used to evaluate bone resorption, Serum N-MID osteocalcin to estimate overall bone turnover, and serum P1NP to estimate bone formation. The patients received the drug every week for 12 weeks. They were examined and evaluated for pain, side effects and bone turnover markers at 6 weeks and 12 weeks after the first dose. Eleven patients had mild side effects, with only one requiring ceasing participation in the trial. At the 12 week follow up, 85.3%, had normal serum beta crosslap and all patients had normal serum N-MID osteocalcin. Low serum P1NP was found in 6 patients. All patients had significantly improved pain. The trial drug normalizes bone turnover markers in acceptable numbers of patients during the trial.
Abstract | Reference
