Background During recent years an increasing amount of generic alendronate formulations has become available. Although expected to have the same tolerability and efficacy, head-to head comparison of generic and brand alendronate was never performed.
Objectives Therefore, the objective of our study was to compare tolerability and efficacy of generic (GAln) and brand alendronate (BAln).
Methods A randomized double-blinded single-centre cross-over study in postmenopausal women with osteoporosis using GAln and BAln in a cross-over setting, each for a period of 12 weeks with visits at baseline, week 4, 12, 16 and 24. Tolerance was evaluated by the Gastro-Intestinal Symptom Rating Scale (GSRS) and by self-reported side effects. Efficacy was assessed by bone turnover markers (CTX and PINP).
Results 37 women (age; 65,4±6,4 years) were enrolled. Abdominal pain score at wk4 and wk16 was higher after GAln compared to BAln (B: 0,24; CI: 0,07- 0,4). After wk4 upper gastro-intestinal side effects (B: 0,20; CI: 0,03-0,33) and dyspepsia (B: 0,15; CI:0,02-0,28), were more reported after GAln. After adjustments for tolerance, BAln demonstrated a lower level of CTX than GAln at wk4 (B: 121,3;CI:51,98-190,5), but not at wk12 (B: 53,6; CI:-3,71-111). PINP was lower for women who received BAln at wk12 (B: 8,93;CI: 0,35-17,5).
Conclusions In postmenopausal women with osteoporosis, generic alendronate caused significantly more gastro-intestinal side-effects during the first weeks of treatment. Markers of bone resorption and formation were significantly higher at week 4 and 12 with generic alendronate. Generic alendronate may not have the same tolerability and efficacy as branded alendronate.
Disclosure of Interest None Declared