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Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy.
J Bone Miner Res 2002; 17(1):1-10JB

Abstract

Although low absolute values of bone mineral density (BMD) predict increased fracture risk in osteoporosis, it is not certain how well increases in BMD with antiresorptive therapy predict observed reductions in fracture risk. This work examines the relationships between changes in BMD after 1 year or 3 years of raloxifene or placebo therapy and the risk for new vertebral fractures at 3 years. In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, 7705 postmenopausal women with osteoporosis were randomized to placebo or raloxifene 60 mg/day or 120 mg/day. Relationships between baseline BMD and changes in BMD from baseline with the risk of new vertebral fractures were analyzed in this cohort using logistic regression models with the raloxifene doses pooled. As has been observed in other populations, women with the lowest baseline lumbar spine or femoral neck BMD in the MORE cohort had the greatest risk for vertebral fractures. Furthermore, for any percentage change, either increase or decrease in femoral neck or lumbar spine BMD at 1 year or 3 years, raloxifene-treated patients had a statistically significantly lower vertebral fracture risk compared with placebo-treated patients. The decrease in fracture risk with raloxifene was similar across the range of percentage change in femoral neck BMD observed at 3 years; patients receiving raloxifene had a 36% lower risk of vertebral fracture compared with those receiving placebo. At any percentage change in femoral neck and lumbar spine BMD observed at 1 year, raloxifene treatment decreased the risks of new vertebral fractures at 3 years by 38% and 41%, respectively. The logistic regression model showed that the percentage changes in BMD with raloxifene treatment accounted for 4% of the observed vertebral fracture risk reduction, and the other 96% of the risk reduction remains unexplained. The present data show that the measured BMD changes observed with raloxifene therapy are poor predictors of vertebral fracture risk reduction with raloxifene therapy.

Authors+Show Affiliations

Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

11771654

Citation

Sarkar, Somnath, et al. "Relationships Between Bone Mineral Density and Incident Vertebral Fracture Risk With Raloxifene Therapy." Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, vol. 17, no. 1, 2002, pp. 1-10.
Sarkar S, Mitlak BH, Wong M, et al. Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. J Bone Miner Res. 2002;17(1):1-10.
Sarkar, S., Mitlak, B. H., Wong, M., Stock, J. L., Black, D. M., & Harper, K. D. (2002). Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, 17(1), pp. 1-10.
Sarkar S, et al. Relationships Between Bone Mineral Density and Incident Vertebral Fracture Risk With Raloxifene Therapy. J Bone Miner Res. 2002;17(1):1-10. PubMed PMID: 11771654.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Relationships between bone mineral density and incident vertebral fracture risk with raloxifene therapy. AU - Sarkar,Somnath, AU - Mitlak,Bruce H, AU - Wong,Mayme, AU - Stock,John L, AU - Black,Dennis M, AU - Harper,Kristine D, PY - 2002/1/5/pubmed PY - 2002/6/18/medline PY - 2002/1/5/entrez SP - 1 EP - 10 JF - Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research JO - J. Bone Miner. Res. VL - 17 IS - 1 N2 - Although low absolute values of bone mineral density (BMD) predict increased fracture risk in osteoporosis, it is not certain how well increases in BMD with antiresorptive therapy predict observed reductions in fracture risk. This work examines the relationships between changes in BMD after 1 year or 3 years of raloxifene or placebo therapy and the risk for new vertebral fractures at 3 years. In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, 7705 postmenopausal women with osteoporosis were randomized to placebo or raloxifene 60 mg/day or 120 mg/day. Relationships between baseline BMD and changes in BMD from baseline with the risk of new vertebral fractures were analyzed in this cohort using logistic regression models with the raloxifene doses pooled. As has been observed in other populations, women with the lowest baseline lumbar spine or femoral neck BMD in the MORE cohort had the greatest risk for vertebral fractures. Furthermore, for any percentage change, either increase or decrease in femoral neck or lumbar spine BMD at 1 year or 3 years, raloxifene-treated patients had a statistically significantly lower vertebral fracture risk compared with placebo-treated patients. The decrease in fracture risk with raloxifene was similar across the range of percentage change in femoral neck BMD observed at 3 years; patients receiving raloxifene had a 36% lower risk of vertebral fracture compared with those receiving placebo. At any percentage change in femoral neck and lumbar spine BMD observed at 1 year, raloxifene treatment decreased the risks of new vertebral fractures at 3 years by 38% and 41%, respectively. The logistic regression model showed that the percentage changes in BMD with raloxifene treatment accounted for 4% of the observed vertebral fracture risk reduction, and the other 96% of the risk reduction remains unexplained. The present data show that the measured BMD changes observed with raloxifene therapy are poor predictors of vertebral fracture risk reduction with raloxifene therapy. SN - 0884-0431 UR - https://www.unboundmedicine.com/medline/citation/11771654/Relationships_between_bone_mineral_density_and_incident_vertebral_fracture_risk_with_raloxifene_therapy_ L2 - https://doi.org/10.1359/jbmr.2002.17.1.1 DB - PRIME DP - Unbound Medicine ER -