Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax®) for osteoporosis treatment

Abstract

Introduction: Although the same efficacy and tolerability are anticipated due to both drugs containing the same active ingredients, comparative studies between brand and generic alendronate are limited. Accordingly, the objective of this study was to compare efficacy and safety between brand alendronate and a recently introduced generic alendronate drug.

Methods: A total of 140 postmenopausal women or men aged older than 50 years who met the indications for osteoporosis treatment were randomized to receive either generic (Bonmax®) or brand alendronate (Fosamax®) 70 mg/week over a 12-month period during the May 2014 to June 2015 study period. Endpoints included bone mineral density (BMD) changes at the lumbar spine, total hip, and femoral neck; percentage of patients with predefined levels of change in total hip and lumbar spine BMD at 12 months; and, changes in biochemical bone markers at 3, 6, and 12 months. Tolerability was evaluated by patient self-reporting of adverse experiences.

Results: At 12 months post-treatment, BMD significantly increased at all sites in both groups. There were no differences in BMD percentage changes or the number of patients with stable or increased BMD after 1 year between groups. No significant differences in the amount of biochemical bone marker reduction or incidence of adverse events were observed between groups.

Conclusions: Generic and brand alendronate produced similar gains in BMD and reduction in bone turnover markers. Both medicadoitions were also equally well-tolerated. Based on these findings, generic alendronate (Bonmax®) is a viable alternative to the original brand of alendronate.

Trial registration: ClinicalTrials.gov NCT02371252.

Fig 1. Consolidated Standards of Reporting Trials (CONSORT) diagram illustrating the flow of patients in this study.

Fig 2. “Spaghetti plot” graphs showing changes in BMD for each patient at the (A) lumbar spine, (B) femoral neck, and (C) total hip.

Fig 3. Mean values of biochemical bone markers, and within group and between group p-values.

(A) serum β-isomerized C-terminal telopeptide (β-CTx); and, (B) serum total procollagen type 1 amino-terminal propeptide (P1NP) for the generic and brand alendronate patient groups before treatment (baseline) and at 3, 6, and 12 months after treatment. The error bars indicate standard error. The p-values in the graphs compare levels between the generic and brand alendronate patient groups, while within group p-values are shown in the corresponding table below each graph (p-value <0.05 indicates statistical significance).