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Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial.
J Bone Miner Res. 2019 12; 34(12):2213-2219.JB

Abstract

In the randomized, placebo-controlled, double-blind phase 3 ACTIVE study (NCT01343004), 18 months of abaloparatide 80 μg daily (subcutaneous injection) in postmenopausal women at risk of osteoporotic fracture significantly reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and significantly increased bone mineral density (BMD) versus placebo regardless of baseline risk factors. Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months. This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups. Baseline risk subgroups included BMD T-score at the lumbar spine, total hip, and femoral neck (≤ - 2.5 versus > - 2.5 and ≤ -3.0 versus > - 3.0), history of nonvertebral fracture (yes/no), prevalent vertebral fracture (yes/no), and age (<65 versus 65 to <75 versus ≥75 years). Forest plots display treatment effect. Treatment-by-subgroup interactions were tested using the Breslow-Day test, Cox proportional hazards model, and ANCOVA model. After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups. BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group. No clinically meaningful interaction between treatment assignment and any baseline risk variable was observed. The sequence of abaloparatide for 18 months followed by alendronate for up to 24 months appears to be an effective treatment option for a wide range of postmenopausal women at risk for osteoporotic fractures. © 2019 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc.

Authors+Show Affiliations

Harvard Medical School, Boston, MA, USA.Radius Health, Inc., Waltham, MA, USA.Radius Health, Inc., Waltham, MA, USA.Radius Health, Inc., Waltham, MA, USA.School of Medicine, University of California at Davis, Sacramento, CA, USA.Medstar Georgetown University Hospital, Washington, DC, USA.David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31411768

Citation

Leder, Benjamin Z., et al. "Fracture and Bone Mineral Density Response By Baseline Risk in Patients Treated With Abaloparatide Followed By Alendronate: Results From the Phase 3 ACTIVExtend Trial." Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, vol. 34, no. 12, 2019, pp. 2213-2219.
Leder BZ, Zapalowski C, Hu MY, et al. Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial. J Bone Miner Res. 2019;34(12):2213-2219.
Leder, B. Z., Zapalowski, C., Hu, M. Y., Hattersley, G., Lane, N. E., Singer, A. J., & Dore, R. K. (2019). Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial. Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research, 34(12), 2213-2219. https://doi.org/10.1002/jbmr.3848
Leder BZ, et al. Fracture and Bone Mineral Density Response By Baseline Risk in Patients Treated With Abaloparatide Followed By Alendronate: Results From the Phase 3 ACTIVExtend Trial. J Bone Miner Res. 2019;34(12):2213-2219. PubMed PMID: 31411768.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial. AU - Leder,Benjamin Z, AU - Zapalowski,Carol, AU - Hu,Ming-Yi, AU - Hattersley,Gary, AU - Lane,Nancy E, AU - Singer,Andrea J, AU - Dore,Robin K, Y1 - 2019/09/11/ PY - 2019/04/19/received PY - 2019/07/12/revised PY - 2019/08/05/accepted PY - 2019/8/15/pubmed PY - 2020/9/12/medline PY - 2019/8/15/entrez KW - ABALOPARATIDE KW - BASELINE RISK SUBGROUPS KW - BONE MINERAL DENSITY KW - FRACTURE PREVENTION KW - POSTMENOPAUSAL OSTEOPOROSIS SP - 2213 EP - 2219 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 - 34 IS - 12 N2 - In the randomized, placebo-controlled, double-blind phase 3 ACTIVE study (NCT01343004), 18 months of abaloparatide 80 μg daily (subcutaneous injection) in postmenopausal women at risk of osteoporotic fracture significantly reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and significantly increased bone mineral density (BMD) versus placebo regardless of baseline risk factors. Women from the abaloparatide and placebo groups who completed ACTIVE were eligible for ACTIVExtend (NCT01657162), in which all enrollees received sequential, open-label monotherapy with alendronate 70 mg once weekly for up to 24 months. This prespecified analysis evaluated whether fracture risk reductions and bone mineral density (BMD) gains associated with abaloparatide during ACTIVE persisted through the full 43-month ACTIVE-ACTIVExtend study period in nine prespecified baseline risk subgroups. Baseline risk subgroups included BMD T-score at the lumbar spine, total hip, and femoral neck (≤ - 2.5 versus > - 2.5 and ≤ -3.0 versus > - 3.0), history of nonvertebral fracture (yes/no), prevalent vertebral fracture (yes/no), and age (<65 versus 65 to <75 versus ≥75 years). Forest plots display treatment effect. Treatment-by-subgroup interactions were tested using the Breslow-Day test, Cox proportional hazards model, and ANCOVA model. After the combined ACTIVE-ACTIVExtend study period, reductions in relative risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures were greater among patients in the abaloparatide/alendronate group than among those in the placebo/alendronate group across all nine baseline risk subgroups. BMD gains at the lumbar spine, total hip, and femoral neck were greater in the abaloparatide/alendronate group versus the placebo/alendronate group. No clinically meaningful interaction between treatment assignment and any baseline risk variable was observed. The sequence of abaloparatide for 18 months followed by alendronate for up to 24 months appears to be an effective treatment option for a wide range of postmenopausal women at risk for osteoporotic fractures. © 2019 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals, Inc. SN - 1523-4681 UR - https://www.unboundmedicine.com/medline/citation/31411768/Fracture_and_Bone_Mineral_Density_Response_by_Baseline_Risk_in_Patients_Treated_With_Abaloparatide_Followed_by_Alendronate:_Results_From_the_Phase_3_ACTIVExtend_Trial_ L2 - https://doi.org/10.1002/jbmr.3848 DB - PRIME DP - Unbound Medicine ER -