Alendronate is one of the most popular anti-resorptive drugs and widely used to treat osteoporotic patients in the world. In Japan, alendronate oral jelly (ALN-J) as a new formulation was launched in 2013. Dissolution test and bioequivalence study were performed between ALN-J and alendronate oral weekly tablet (ALN-T), and bioequivalence of both drugs was approved. Dosage and administration of ALN-J is the same as ALN-T. Moreover, ALN-J has special features of easy swallowing and obvious distinguishability compared with ALN-T. However, little is known about clinical evidence such as BMD, bone turnover marker, safety and adherence in the treatment with ALN-J. We conducted the present study to verify the efficacy and safety of ALN-J in the treatment of osteoporosis. A number of 32 patients were enrolled in the present study, and age, history of prevalent fractures, BMD, bone turnover marker and others were investigated. Baseline characteristics of the patients were as follows; mean (S.D.) of age (years) was 78.25 (6.58); radius BMD (g/cm2), 0.45 (0.07); TRACP5b (mU/dl), 497.42 (160.92); P1NP (μg/l), 64.90 (25.66) respectively. After treatment, mean change in TRACP5b decreased by 36.7% and P1NP decreased by 43.7% for 3 months. The effect of ALN-J for change in bone turnover marker was confirmed in the treatment of osteoporosis in brief duration.
17 May 2014 - 20 May 2014