CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 140 enrolled
Drug / intervention
Generic alendronatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02371252
NCT02371252Phase 4Completed

Randomized Trial Comparing Efficacy and Safety of Brand Versus Generic Alendronate for Osteoporosis Treatment

Mahidol University·interventional·Posted Feb 25, 2015·Updated Sep 29, 2021

In Brief

A Phase 4 clinical trial evaluating Generic alendronate for Osteoporosis. Completed, enrolled 140 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesThailand
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 25, 2015
Enrollment StartApr 1, 2014
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.4 years ago

Interventions

Generic alendronatedrug

The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.