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Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture.
Clin Ther. 2020 06; 42(6):1099-1107.e1.CT

Abstract

PURPOSE

Current treatment guidelines recommend treatment for postmenopausal women with a T score <2.5 regardless of age. This subgroup analysis evaluated the efficacy and safety of abaloparatide in younger postmenopausal women considered to be at high risk for fracture.

METHODS

Subgroup analysis of women in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial who were <65 years old and met modified utilization management criteria (baseline T score ≤-2.5 [any site] and ≥1 prevalent vertebral and/or ≥1 prior clinical fracture within 5 years of randomization).

FINDINGS

A total of 296 women (age range, 49-64 years) were included. Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites). Fracture rates were numerically lower for abaloparatide versus placebo, consistent with the overall trial results, although the differences were not statistically significant. The number needed to treat to prevent 1 additional vertebral fracture after 18 months of treatment versus placebo was 18 for abaloparatide and 21 for teriparatide. The number needed to treat had nonsignificant trends toward lower values with abaloparatide versus teriparatide for nonvertebral fractures (23 vs 40) and clinical fractures (16 vs 73) and similar for major osteoporotic fractures (24 vs 27). The safety profile was consistent with the overall ACTIVE population.

IMPLICATIONS

Findings of this subgroup (post hoc) analysis are consistent with the overall ACTIVE population. Abaloparatide appears to be effective and well tolerated in this subgroup of younger postmenopausal women. ClinicalTrials.gov identifier: NCT01343004.

Authors+Show Affiliations

Department of Medicine, University of Alabama, Birmingham, AL, USA.Radius Health Inc, Waltham, MA, USA.Radius Health Inc, Waltham, MA, USA.Radius Health Inc, Waltham, MA, USA. Electronic address: rweiss@radiuspharm.com.School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

32513495

Citation

Saag, Kenneth G., et al. "Effect of Abaloparatide On Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women With Osteoporosis at High Risk for Fracture." Clinical Therapeutics, vol. 42, no. 6, 2020, pp. 1099-1107.e1.
Saag KG, Williams SA, Wang Y, et al. Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture. Clin Ther. 2020;42(6):1099-1107.e1.
Saag, K. G., Williams, S. A., Wang, Y., Weiss, R. J., & Cauley, J. A. (2020). Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture. Clinical Therapeutics, 42(6), 1099-e1. https://doi.org/10.1016/j.clinthera.2020.04.012
Saag KG, et al. Effect of Abaloparatide On Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women With Osteoporosis at High Risk for Fracture. Clin Ther. 2020;42(6):1099-1107.e1. PubMed PMID: 32513495.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Abaloparatide on Bone Mineral Density and Fracture Incidence in a Subset of Younger Postmenopausal Women with Osteoporosis at High Risk for Fracture. AU - Saag,Kenneth G, AU - Williams,Setareh A, AU - Wang,Yamei, AU - Weiss,Richard J, AU - Cauley,Jane A, Y1 - 2020/06/06/ PY - 2019/12/02/received PY - 2020/03/13/revised PY - 2020/04/21/accepted PY - 2020/6/10/pubmed PY - 2021/2/9/medline PY - 2020/6/10/entrez KW - abaloparatide KW - nonvertebral fracture KW - number needed to treat KW - osteoporosis KW - vertebral fracture SP - 1099 EP - 1107.e1 JF - Clinical therapeutics JO - Clin Ther VL - 42 IS - 6 N2 - PURPOSE: Current treatment guidelines recommend treatment for postmenopausal women with a T score <2.5 regardless of age. This subgroup analysis evaluated the efficacy and safety of abaloparatide in younger postmenopausal women considered to be at high risk for fracture. METHODS: Subgroup analysis of women in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial who were <65 years old and met modified utilization management criteria (baseline T score ≤-2.5 [any site] and ≥1 prevalent vertebral and/or ≥1 prior clinical fracture within 5 years of randomization). FINDINGS: A total of 296 women (age range, 49-64 years) were included. Significant increases in bone mineral density from baseline were observed for abaloparatide versus placebo at all 3 sites at 6 months (p < 0.01 for total hip and femoral neck; p < 0.0001 for lumbar spine), 12 months (p < 0.0001 at all 3 sites), and 18 months (p < 0.0001 at all 3 sites). Fracture rates were numerically lower for abaloparatide versus placebo, consistent with the overall trial results, although the differences were not statistically significant. The number needed to treat to prevent 1 additional vertebral fracture after 18 months of treatment versus placebo was 18 for abaloparatide and 21 for teriparatide. The number needed to treat had nonsignificant trends toward lower values with abaloparatide versus teriparatide for nonvertebral fractures (23 vs 40) and clinical fractures (16 vs 73) and similar for major osteoporotic fractures (24 vs 27). The safety profile was consistent with the overall ACTIVE population. IMPLICATIONS: Findings of this subgroup (post hoc) analysis are consistent with the overall ACTIVE population. Abaloparatide appears to be effective and well tolerated in this subgroup of younger postmenopausal women. ClinicalTrials.gov identifier: NCT01343004. SN - 1879-114X UR - https://www.unboundmedicine.com/medline/citation/32513495/Effect_of_Abaloparatide_on_Bone_Mineral_Density_and_Fracture_Incidence_in_a_Subset_of_Younger_Postmenopausal_Women_with_Osteoporosis_at_High_Risk_for_Fracture_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0149-2918(20)30199-5 DB - PRIME DP - Unbound Medicine ER -