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FRAX and the effect of teriparatide on vertebral and non-vertebral fracture.
Osteoporos Int. 2015 Nov; 26(11):2677-84.OI

Abstract

Daily teriparatide injections have been shown to reduce vertebral and non-vertebral fractures. Here, we demonstrate that the magnitude of fracture risk reduction is independent of baseline fracture probability assessed by FRAX.

INTRODUCTION

Daily administration of 20 or 40 μg teriparatide has been shown to significantly decrease the risk of vertebral and non-vertebral fracture compared with placebo. The aim of the present study was to evaluate fracture risk assessed at baseline using the FRAX® tool and to determine the efficacy of teriparatide as a function of baseline fracture risk.

METHODS

One thousand six hundred thirty-seven postmenopausal women in the pivotal phase three trial, randomly assigned to receive placebo (n = 544), teriparatide 20 μg per day (n = 541) or teriparatide 40 μg per day (n = 552), were studied. Baseline clinical risk factors were entered into country-specific FRAX models to compute the 10-year probability of major osteoporotic fractures with or without input of femoral neck BMD. Because there was no difference in effect of 20 and 40 μg teriparatide daily on fracture occurrence, the two active groups were merged. The interaction between probability of a major fracture and treatment efficacy was examined by Poisson regression.

RESULTS

The 10-year probability of major osteoporotic fractures (with BMD) ranged from 2.2-67.2 %. Treatment with teriparatide was associated with a 37 % decrease in all non-vertebral fractures (95 % CI 10-56 %) and a 56 % decrease in low-energy non-vertebral fractures (95 % CI 24-75 %) compared with placebo. The risk of morphometric vertebral fractures decreased significantly by 66 % (95 % CI 50-77 %). Hazard ratios for the effect of teriparatide on the fracture outcome did not change significantly with increasing fracture probability (p > 0.30). Similar findings were noted for the interaction when BMD was excluded from the FRAX model, or when probability of hip fracture was used as the marker of baseline risk.

CONCLUSION

We conclude that teriparatide significantly decreases the risk of non-vertebral and morphometric vertebral fractures in women by a similar extent, irrespective of baseline fracture probability.

Authors+Show Affiliations

MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK. w.j.pontefract@sheffield.ac.uk.Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.Bone, Muscle and Joint Platform, Eli Lilly and Company, Indianapolis, IN, USA.Bone, Muscle and Joint Platform, Eli Lilly and Company, Indianapolis, IN, USA.Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.Centre for Metabolic Bone Diseases, University of Sheffield Medical School, Beech Hill Road, Sheffield, S10 2RX, UK.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26092063

Citation

Harvey, N C., et al. "FRAX and the Effect of Teriparatide On Vertebral and Non-vertebral Fracture." Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, vol. 26, no. 11, 2015, pp. 2677-84.
Harvey NC, Kanis JA, Odén A, et al. FRAX and the effect of teriparatide on vertebral and non-vertebral fracture. Osteoporos Int. 2015;26(11):2677-84.
Harvey, N. C., Kanis, J. A., Odén, A., Burge, R. T., Mitlak, B. H., Johansson, H., & McCloskey, E. V. (2015). FRAX and the effect of teriparatide on vertebral and non-vertebral fracture. Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 26(11), 2677-84. https://doi.org/10.1007/s00198-015-3173-3
Harvey NC, et al. FRAX and the Effect of Teriparatide On Vertebral and Non-vertebral Fracture. Osteoporos Int. 2015;26(11):2677-84. PubMed PMID: 26092063.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - FRAX and the effect of teriparatide on vertebral and non-vertebral fracture. AU - Harvey,N C, AU - Kanis,J A, AU - Odén,A, AU - Burge,R T, AU - Mitlak,B H, AU - Johansson,H, AU - McCloskey,E V, Y1 - 2015/06/20/ PY - 2015/03/25/received PY - 2015/05/08/accepted PY - 2015/6/21/entrez PY - 2015/6/21/pubmed PY - 2016/8/2/medline KW - BMD KW - Epidemiology KW - FRAX KW - Fracture KW - Interaction KW - Osteoporosis KW - Randomised controlled trial KW - Teriparatide SP - 2677 EP - 84 JF - Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA JO - Osteoporos Int VL - 26 IS - 11 N2 - UNLABELLED: Daily teriparatide injections have been shown to reduce vertebral and non-vertebral fractures. Here, we demonstrate that the magnitude of fracture risk reduction is independent of baseline fracture probability assessed by FRAX. INTRODUCTION: Daily administration of 20 or 40 μg teriparatide has been shown to significantly decrease the risk of vertebral and non-vertebral fracture compared with placebo. The aim of the present study was to evaluate fracture risk assessed at baseline using the FRAX® tool and to determine the efficacy of teriparatide as a function of baseline fracture risk. METHODS: One thousand six hundred thirty-seven postmenopausal women in the pivotal phase three trial, randomly assigned to receive placebo (n = 544), teriparatide 20 μg per day (n = 541) or teriparatide 40 μg per day (n = 552), were studied. Baseline clinical risk factors were entered into country-specific FRAX models to compute the 10-year probability of major osteoporotic fractures with or without input of femoral neck BMD. Because there was no difference in effect of 20 and 40 μg teriparatide daily on fracture occurrence, the two active groups were merged. The interaction between probability of a major fracture and treatment efficacy was examined by Poisson regression. RESULTS: The 10-year probability of major osteoporotic fractures (with BMD) ranged from 2.2-67.2 %. Treatment with teriparatide was associated with a 37 % decrease in all non-vertebral fractures (95 % CI 10-56 %) and a 56 % decrease in low-energy non-vertebral fractures (95 % CI 24-75 %) compared with placebo. The risk of morphometric vertebral fractures decreased significantly by 66 % (95 % CI 50-77 %). Hazard ratios for the effect of teriparatide on the fracture outcome did not change significantly with increasing fracture probability (p > 0.30). Similar findings were noted for the interaction when BMD was excluded from the FRAX model, or when probability of hip fracture was used as the marker of baseline risk. CONCLUSION: We conclude that teriparatide significantly decreases the risk of non-vertebral and morphometric vertebral fractures in women by a similar extent, irrespective of baseline fracture probability. SN - 1433-2965 UR - https://www.unboundmedicine.com/medline/citation/26092063/FRAX_and_the_effect_of_teriparatide_on_vertebral_and_non_vertebral_fracture_ L2 - https://doi.org/10.1007/s00198-015-3173-3 DB - PRIME DP - Unbound Medicine ER -