Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

Summary

Osteoporosis is a common disease defined as a decrease in bone mass and strength which increases risk of fragility fractures. This disorder may affecting health in many adults which causing disability, morbidity, and mortality. Current first-line medical therapy is bisphosphonates which alendronate is one of the most widely used. However, expenditure on medicines is one of the major problem of inadequate access to treatment. The investigators hypothesized that generic alendronate will have the same clinical efficacy as the brand formulation. Therefore, the result of this study is extremely crucial. If adequate efficacy of generic alendronate could be established and if it affords the same safety profile as those of brand alendronate, the use of generic alendronate could then be recommended.

Timeline

Start

2014-04

Primary completion

2016-12

Completion

2016-12

Publications

• Unnanuntana A, Jarusriwanna A, Songcharoen P. Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax(R)) for osteoporosis treatment. PLoS One. 2017 Jul 5;12(7):e0180325. doi: 10.1371/journal.pone.0180325. eCollection 2017.

Drugs

Indications