Comparing Tolerability and Efficacy of Generic versus Brand Alendronate: A Randomized Clinical Study in Postmenopausal Women with a Recent FractureReport as inadecuate




Comparing Tolerability and Efficacy of Generic versus Brand Alendronate: A Randomized Clinical Study in Postmenopausal Women with a Recent Fracture - Download this document for free, or read online. Document in PDF available to download.

Introduction

An increasing number of generic alendronate formulations have become available. Although expected to have the same tolerability and efficacy, head-to head comparison of generic and brand alendronate was never performed. Therefore, we compared the tolerability and efficacy of generic and brand alendronate.

Methods

In a randomized double-blinded single centre cross-over study in 37 postmenopausal women mean age 65.4±6.4 years with osteoporosis were treated with generic and branded alendronate during 24 2x12 weeks. Tolerance was evaluated by the Gastro intestinal Symptom Rating Scale GSRS and self-reported side effects. Efficacy was assessed by serum bone turnover markers, carboxy terminal telopeptide CTX and procollagen type I N-terminal propeptide PINP. No wash out period was allowed ethical reasons. Because of possible carry over effect only data of the first 12 weeks were analyzed using linear mixed models.

Results

There were no significant differences in overall tolerance GSRS between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4 estimated mean difference B: 0.40; 95%CI: 0.05 to 0.74, p = 0.024. The level of bone turnover markers significantly decreased over 12 weeks of follow-up for generic and branded alendronate p < 0.001. Mean level of CTX was significantly lower with branded at week 4 B: 121.3; 95%CI: 52.0 to 190.5, but not at week 12 B: 53.6; 95%CI:-3.7 to 110.9. No significant differences were found for PINP at week 4 or 12.

Conclusions

Bone turnover markers were significantly reduced with branded and generic alendronate. With branded, CTX was significantly lower at 4 weeks. Generic caused significantly higher abdominal pain scores in the first 4 weeks of treatment. Therefore, generic alendronate may not have the same tolerability and efficacy as branded alendronate in the first weeks after starting treatment in patients with a recent fracture.

Trial Registration

Dutch Trial Register NTR number 1867 http:-www.trialregister.nl-trialreg-admin-rctview.asp?TC=1867



Author: Joop P. W. van den Bergh, Marian E. Bouts, Eveline van der Veer, Robert Y. van der Velde, Marcel J. W. Janssen, Piet P. Geusens,

Source: http://plos.srce.hr/



DOWNLOAD PDF




Related documents