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Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial.
Osteoporos Int. 2021 Jan; 32(1):55-61.OI

Abstract

Abaloparatide increased ultradistal radius bone mineral density (BMD) in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial. Over the subsequent 24 months in ACTIVExtend, ultradistal radius BMD gains were maintained with alendronate. Conversely, 1/3 radius BMD remained stable during ALN treatment in ACTIVExtend after decreasing during ACTIVE.

INTRODUCTION

Abaloparatide (ABL) increased femoral neck, total hip, and lumbar spine bone mineral density (BMD) in postmenopausal women with osteoporosis and decreased the risk of vertebral and nonvertebral fractures in ACTIVE. Effects on fracture risk and BMD were maintained subsequently with alendronate (ALN) in ACTIVExtend. In a prespecified subanalysis of ACTIVE, ABL also increased BMD at the ultradistal radius. Our objective was to determine the efficacy of ABL followed by ALN vs placebo (PBO) followed by ALN on forearm BMD and fracture risk over 43 months in ACTIVExtend.

METHODS

Ultradistal and 1/3 radius BMD (ACTIVE baseline to month 43) were measured (ABL/ALN, n = 213; PBO/ALN, n = 233). Wrist fracture rates were estimated for the ACTIVExtend intent-to-treat population (ABL/ALN, n = 558; PBO/ALN, n = 581) by Kaplan-Meier (KM) method.

RESULTS

At cumulative month 25, mean increase from ACTIVE baseline in ultradistal radius BMD was 1.1% (standard error, 0.49%) with ABL/ALN vs - 0.8% (0.43%) with PBO/ALN (P < 0.01). BMD increases with ABL were maintained with ALN through month 43 in ACTIVExtend. BMD decreases at the 1/3 radius in ACTIVE (similar with ABL and PBO) were maintained through 24 months of ALN treatment in ACTIVExtend. Wrist fractures over 43 months occurred in 15 women with ABL/ALN (KM estimate, 2.8%) and 20 with PBO/ALN (KM estimate, 3.6%) (HR = 0.77, 95% CI 0.39, 1.50; P = not significant).

CONCLUSION

Ultradistal radius BMD gains following treatment with ABL in ACTIVE were maintained over 24 months of ALN treatment in ACTIVExtend. Conversely, 1/3 radius BMD remained stable during ALN treatment in ACTIVExtend after decreasing during ACTIVE.

TRIAL REGISTRATION

ClinicalTrials.gov : NCT01657162 submitted July 31, 2012.

Authors+Show Affiliations

Mercy Health Osteoporosis and Bone Health Services, Cincinnati, OH, USA.Robin K. Dore, MD, Inc., Tustin, CA, USA.Rush University Medical Center, Chicago, IL, USA.Radius Health, Inc., 950 Winter Street, Waltham, MA, 02451, USA. bmitlak@radiuspharm.com.Radius Health, Inc., 950 Winter Street, Waltham, MA, 02451, USA.Radius Health, Inc., 950 Winter Street, Waltham, MA, 02451, USA.Beth Israel Deaconess Medical Center, Boston, MA, USA.Brigham and Women's Hospital, Boston, MA, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article

Language

eng

PubMed ID

32935170

Citation

Watts, N B., et al. "Forearm Bone Mineral Density and Fracture Incidence in Postmenopausal Women With Osteoporosis: Results From the ACTIVExtend Phase 3 Trial." Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, vol. 32, no. 1, 2021, pp. 55-61.
Watts NB, Dore RK, Baim S, et al. Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial. Osteoporos Int. 2021;32(1):55-61.
Watts, N. B., Dore, R. K., Baim, S., Mitlak, B., Hattersley, G., Wang, Y., Rozental, T. D., & LeBoff, M. S. (2021). Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial. Osteoporosis International : a Journal Established as Result of Cooperation Between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 32(1), 55-61. https://doi.org/10.1007/s00198-020-05555-1
Watts NB, et al. Forearm Bone Mineral Density and Fracture Incidence in Postmenopausal Women With Osteoporosis: Results From the ACTIVExtend Phase 3 Trial. Osteoporos Int. 2021;32(1):55-61. PubMed PMID: 32935170.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Forearm bone mineral density and fracture incidence in postmenopausal women with osteoporosis: results from the ACTIVExtend phase 3 trial. AU - Watts,N B, AU - Dore,R K, AU - Baim,S, AU - Mitlak,B, AU - Hattersley,G, AU - Wang,Y, AU - Rozental,T D, AU - LeBoff,M S, Y1 - 2020/09/15/ PY - 2020/01/31/received PY - 2020/07/17/accepted PY - 2020/9/17/pubmed PY - 2021/2/5/medline PY - 2020/9/16/entrez KW - Abaloparatide KW - Alendronate KW - Bone mineral density KW - Osteoporosis KW - Wrist fracture SP - 55 EP - 61 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 - 32 IS - 1 N2 - : Abaloparatide increased ultradistal radius bone mineral density (BMD) in the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial. Over the subsequent 24 months in ACTIVExtend, ultradistal radius BMD gains were maintained with alendronate. Conversely, 1/3 radius BMD remained stable during ALN treatment in ACTIVExtend after decreasing during ACTIVE. INTRODUCTION: Abaloparatide (ABL) increased femoral neck, total hip, and lumbar spine bone mineral density (BMD) in postmenopausal women with osteoporosis and decreased the risk of vertebral and nonvertebral fractures in ACTIVE. Effects on fracture risk and BMD were maintained subsequently with alendronate (ALN) in ACTIVExtend. In a prespecified subanalysis of ACTIVE, ABL also increased BMD at the ultradistal radius. Our objective was to determine the efficacy of ABL followed by ALN vs placebo (PBO) followed by ALN on forearm BMD and fracture risk over 43 months in ACTIVExtend. METHODS: Ultradistal and 1/3 radius BMD (ACTIVE baseline to month 43) were measured (ABL/ALN, n = 213; PBO/ALN, n = 233). Wrist fracture rates were estimated for the ACTIVExtend intent-to-treat population (ABL/ALN, n = 558; PBO/ALN, n = 581) by Kaplan-Meier (KM) method. RESULTS: At cumulative month 25, mean increase from ACTIVE baseline in ultradistal radius BMD was 1.1% (standard error, 0.49%) with ABL/ALN vs - 0.8% (0.43%) with PBO/ALN (P < 0.01). BMD increases with ABL were maintained with ALN through month 43 in ACTIVExtend. BMD decreases at the 1/3 radius in ACTIVE (similar with ABL and PBO) were maintained through 24 months of ALN treatment in ACTIVExtend. Wrist fractures over 43 months occurred in 15 women with ABL/ALN (KM estimate, 2.8%) and 20 with PBO/ALN (KM estimate, 3.6%) (HR = 0.77, 95% CI 0.39, 1.50; P = not significant). CONCLUSION: Ultradistal radius BMD gains following treatment with ABL in ACTIVE were maintained over 24 months of ALN treatment in ACTIVExtend. Conversely, 1/3 radius BMD remained stable during ALN treatment in ACTIVExtend after decreasing during ACTIVE. TRIAL REGISTRATION: ClinicalTrials.gov : NCT01657162 submitted July 31, 2012. SN - 1433-2965 UR - https://www.unboundmedicine.com/medline/citation/32935170/Forearm_bone_mineral_density_and_fracture_incidence_in_postmenopausal_women_with_osteoporosis:_results_from_the_ACTIVExtend_phase_3_trial_ L2 - https://doi.org/10.1007/s00198-020-05555-1 DB - PRIME DP - Unbound Medicine ER -