Journal article
Efficacy of Continued Alendronate for Fractures in Women With and Without Prevalent Vertebral Fracture: The FLEX Trial
Journal of bone and mineral research, Vol.25(5), pp.976-982
05/01/2010
DOI: 10.1002/jbmr.11
PMID: 20200926
Abstract
In the Fracture Intervention Trial (FIT) Long Term Extension (FLEX) Trial, 10 years of alendronate (ALN) did not significantly reduce the risk of nonvertebral fractures (NVFs) compared with 5 years of ALN. Continuing ALN reduced the risk of clinical but not morphometric vertebral fractures regardless of baseline vertebral fracture status. In previous studies, ALN efficacy for NVF prevention in women without prevalent vertebral fracture was limited to those with femoral neck (FN) T-scores of -2.5 or less. To determine whether the effect of long-term ALN on fracture differs by vertebral fracture status and femoral neck (FN) T-score, we performed a post hoc analysis using FLEX data, a randomized, double-blind, placebo-controlled trial among 1099 postmenopausal women originally randomized to ALN in the FIT with mean ALN use of 5 years. In the FLEX Trial, women were randomized to placebo (40%) or ALN 5 mg/day (30%) or ALN 10 mg/day (30%) for an additional 5 years. Among women without vertebral fracture at FLEX baseline (n = 720), continuation of ALN reduced NVF in women with FLEX baseline FN T-scores of -2.5 or less [relative risk (RR) = 0.50, 95% confidence interval (Cl) 0.26-0.96] but not with T-scores of greater than -2.5 and -2 or less (RR 0.79, 95% Cl 0.37-1.66) or with T-scores of greater than -2 (RR 1.41, 95% Cl 0.75-2.66; p for interaction = .019). Continuing ALN for 10 years instead of stopping after 5 years reduces NVF risk in women without prevalent vertebral fracture whose FN T-scores, achieved after 5 years of ALN, are -2.5 or less but does not reduce risk of NVF in women whose T-scores are greater than -2. (C) 2010 American Society for Bone and Mineral Research.
Details
- Title: Subtitle
- Efficacy of Continued Alendronate for Fractures in Women With and Without Prevalent Vertebral Fracture: The FLEX Trial
- Creators
- Ann V. Schwartz - University of California, San FranciscoDouglas C. Bauer - University of California, San FranciscoSteven R. Cummings - California Pacific Medical CenterJane A. Cauley - University of PittsburghKristine E. Ensrud - University of MinnesotaLisa Palermo - University of California, San FranciscoRobert B. Wallace - University of IowaMarc C. Hochberg - University of Maryland Medical CenterAdrianne C. Feldstein - Kaiser Permanente Center for Health ResearchAntonio Lombardi - Merck & Co., Inc., Rahway, NJ, USADennis M. Black - University of California, San FranciscoFLEX Research Group
- Resource Type
- Journal article
- Publication Details
- Journal of bone and mineral research, Vol.25(5), pp.976-982
- DOI
- 10.1002/jbmr.11
- PMID
- 20200926
- NLM abbreviation
- J Bone Miner Res
- ISSN
- 0884-0431
- eISSN
- 1523-4681
- Publisher
- Wiley
- Number of pages
- 7
- Grant note
- Merck Co; Merck & Company
- Language
- English
- Date published
- 05/01/2010
- Academic Unit
- Epidemiology; Injury Prevention Research Center; Internal Medicine
- Record Identifier
- 9984363587502771
Metrics
11 Record Views