Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/16006
Title: Comparing Tolerability and Efficacy of Generic versus Brand Alendronate: A Randomized Clinical Study in Postmenopausal Women with a Recent Fracture
Authors: van den Bergh, Joop P. W.
Bouts, Marian E.
van der Veer, Eveline
van der Velde, Robert Y.
Janssen, Marcel J. W.
GEUSENS, Piet 
Winkens, Bjorn
Oldenhof, Nico J. J.
van Geel, Tineke A. C. M.
Issue Date: 2013
Source: PLOS ONE, 8 (10), (ART N° e78153)
Abstract: 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
Document URI: http://hdl.handle.net/1942/16006
ISSN: 1932-6203
e-ISSN: 1932-6203
DOI: 10.1371/journal.pone.0078153
ISI #: 000326032600075
Category: A1
Type: Journal Contribution
Validations: ecoom 2014
Appears in Collections:Research publications

Files in This Item:
File Description SizeFormat 
van den bergh 1.pdfartikel595.65 kBAdobe PDFView/Open
Show full item record

SCOPUSTM   
Citations

9
checked on Sep 3, 2020

WEB OF SCIENCETM
Citations

9
checked on May 13, 2022

Page view(s)

58
checked on May 18, 2022

Download(s)

76
checked on May 18, 2022

Google ScholarTM

Check

Altmetric


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.