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Effect of weekly teriparatide does not vary by baseline fracture probability calculated using FRAX

Effect of weekly teriparatide does not vary by baseline fracture probability calculated using FRAX
Effect of weekly teriparatide does not vary by baseline fracture probability calculated using FRAX
Summary: The aim of this study was to determine the efficacy of once-weekly teriparatide as a function of baseline fracture risk. Treatment with once-weekly teriparatide was associated with a statistically significant 79 % decrease in vertebral fractures, and in the cohort as a whole, efficacy was not related to baseline fracture risk.

Introduction: Previous studies have suggested that the efficacy of some interventions may be greater in the segment of the population at highest fracture risk as assessed by the FRAX® algorithms. The aim of the present study was to determine whether the antifracture efficacy of weekly teriparatide was dependent on the magnitude of fracture risk.

Methods: Baseline fracture probabilities (using FRAX) were computed from the primary data of a phase 3 study (TOWER) of the effects of weekly teriparatide in 542 men and postmenopausal women with osteoporosis. The outcome variable comprised morphometric vertebral fractures. Interactions between fracture probability and efficacy were explored by Poisson regression.

Results: The 10-year probability of major osteoporotic fractures (without BMD) ranged from 7.2 to 42.2 %. FRAX-based hip fracture probabilities ranged from 0.9 to 29.3 %. Treatment with teriparatide was associated with a 79 % (95 % CI 52–91 %) decrease in vertebral fractures assessed by semiquantitative morphometry. Relative risk reductions for the effect of teriparatide on the fracture outcome did not change significantly across the range of fracture probabilities (p?=?0.28). In a subgroup analysis of 346 (64 %) participants who had FRAX probabilities calculated with the inclusion of BMD, there was a small but significant interaction (p?=?0.028) between efficacy and baseline fracture probability such that high fracture probabilities were associated with lower efficacy.

Conclusion: Weekly teriparatide significantly decreased the risk of morphometric vertebral fractures in men and postmenopausal women with osteoporosis. Overall, the efficacy of teriparatide was not dependent on the level of fracture risk assessed by FRAX in the cohort as a whole.
epidemiology, frax, osteoporosis, randomised controlled trial, teriparatide, vertebral fracture
0937-941X
2347-2353
Harvey, N.C.
ce487fb4-d360-4aac-9d17-9466d6cba145
Kanis, J.A.
8da04a36-08a7-4310-b4b4-a6d432439587
Oden, A.
c018cdda-62cd-44a0-be3a-227484a568bb
Nakamura, T.
513b780a-4252-4380-8a41-07d966cad552
Shiraki, M.
de76cf36-d1da-4090-96dd-985504a6f357
Sugimoto, T.
9acd2f58-c4c5-4843-a963-2b8359fcb1af
Kuroda, T.
a669fc92-d2c3-4171-9084-814ec980a2a1
Johansson, H.
05aa5476-bcb9-4b97-905e-00f1dfd9d691
McCloskey, E.V.
38518227-db8f-4a53-88a6-462f469151de
Harvey, N.C.
ce487fb4-d360-4aac-9d17-9466d6cba145
Kanis, J.A.
8da04a36-08a7-4310-b4b4-a6d432439587
Oden, A.
c018cdda-62cd-44a0-be3a-227484a568bb
Nakamura, T.
513b780a-4252-4380-8a41-07d966cad552
Shiraki, M.
de76cf36-d1da-4090-96dd-985504a6f357
Sugimoto, T.
9acd2f58-c4c5-4843-a963-2b8359fcb1af
Kuroda, T.
a669fc92-d2c3-4171-9084-814ec980a2a1
Johansson, H.
05aa5476-bcb9-4b97-905e-00f1dfd9d691
McCloskey, E.V.
38518227-db8f-4a53-88a6-462f469151de

Harvey, N.C., Kanis, J.A., Oden, A., Nakamura, T., Shiraki, M., Sugimoto, T., Kuroda, T., Johansson, H. and McCloskey, E.V. (2015) Effect of weekly teriparatide does not vary by baseline fracture probability calculated using FRAX. Osteoporosis International, 26 (9), 2347-2353. (doi:10.1007/s00198-015-3129-7). (PMID:26092062)

Record type: Article

Abstract

Summary: The aim of this study was to determine the efficacy of once-weekly teriparatide as a function of baseline fracture risk. Treatment with once-weekly teriparatide was associated with a statistically significant 79 % decrease in vertebral fractures, and in the cohort as a whole, efficacy was not related to baseline fracture risk.

Introduction: Previous studies have suggested that the efficacy of some interventions may be greater in the segment of the population at highest fracture risk as assessed by the FRAX® algorithms. The aim of the present study was to determine whether the antifracture efficacy of weekly teriparatide was dependent on the magnitude of fracture risk.

Methods: Baseline fracture probabilities (using FRAX) were computed from the primary data of a phase 3 study (TOWER) of the effects of weekly teriparatide in 542 men and postmenopausal women with osteoporosis. The outcome variable comprised morphometric vertebral fractures. Interactions between fracture probability and efficacy were explored by Poisson regression.

Results: The 10-year probability of major osteoporotic fractures (without BMD) ranged from 7.2 to 42.2 %. FRAX-based hip fracture probabilities ranged from 0.9 to 29.3 %. Treatment with teriparatide was associated with a 79 % (95 % CI 52–91 %) decrease in vertebral fractures assessed by semiquantitative morphometry. Relative risk reductions for the effect of teriparatide on the fracture outcome did not change significantly across the range of fracture probabilities (p?=?0.28). In a subgroup analysis of 346 (64 %) participants who had FRAX probabilities calculated with the inclusion of BMD, there was a small but significant interaction (p?=?0.028) between efficacy and baseline fracture probability such that high fracture probabilities were associated with lower efficacy.

Conclusion: Weekly teriparatide significantly decreased the risk of morphometric vertebral fractures in men and postmenopausal women with osteoporosis. Overall, the efficacy of teriparatide was not dependent on the level of fracture risk assessed by FRAX in the cohort as a whole.

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Accepted/In Press date: 17 March 2015
e-pub ahead of print date: 20 June 2015
Published date: September 2015
Keywords: epidemiology, frax, osteoporosis, randomised controlled trial, teriparatide, vertebral fracture
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 386917
URI: http://eprints.soton.ac.uk/id/eprint/386917
ISSN: 0937-941X
PURE UUID: 09ffb8f8-a72e-4433-97e8-a0b3605fe040
ORCID for N.C. Harvey: ORCID iD orcid.org/0000-0002-8194-2512

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Date deposited: 05 Feb 2016 12:27
Last modified: 29 Oct 2019 01:51

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Contributors

Author: N.C. Harvey ORCID iD
Author: J.A. Kanis
Author: A. Oden
Author: T. Nakamura
Author: M. Shiraki
Author: T. Sugimoto
Author: T. Kuroda
Author: H. Johansson
Author: E.V. McCloskey

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