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Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial.
Mayo Clin Proc. 2017 Feb; 92(2):200-210.MC

Abstract

OBJECTIVE

To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis).

PATIENTS AND METHODS

ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients.

RESULTS

Of 1243 eligible ACTIVE patients, 1139 (92%) were enrolled in ACTIVExtend beginning November 20, 2012. These results are from a prespecified 6-month interim analysis (cutoff date, June 2, 2015); the study is ongoing. Findings indicated percentages of patients with new morphometric vertebral fractures: PBO/ALN, 4.4% vs ABL-SC/ALN, 0.55%; relative risk reduction, 87% (relative risk, 0.13; 95% CI, 0.04-0.41; P<.001). Kaplan-Meier estimated rates of nonvertebral fractures were PBO/ALN, 5.6% vs ABL-SC/ALN, 2.7%; risk reduction, 52% (hazard ratio [HR], 0.48; 95% CI, 0.26-0.89; log-rank P=.02). There was also a 58% risk reduction of major osteoporotic fractures (HR, 0.42; 95% CI, 0.21-0.85; log-rank P=.01) and a 45% risk reduction of clinical fractures (HR, 0.55; 95% CI, 0.33-0.92; log-rank P=.02) in the ABL-SC/ALN group vs the PBO/ALN group. At 25 months, bone mineral density percentage change from ACTIVE baseline for ABL-SC/ALN vs PBO/ALN was as follows: lumbar spine, 12.8%; total hip, 5.5%; femoral neck, 4.5% vs 3.5%, 1.4%, 0.5%, respectively (group differences at all sites P<.001).

CONCLUSION

Use of ABL-SC for 18 months followed by ALN for 6 months improved bone mineral density and reduced fracture risk throughout the skeleton and may be an effective treatment option for postmenopausal women with osteoporosis.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT01657162.

Authors+Show Affiliations

Department of Clinical Medicine, Columbia University, New York, NY; Clinical Research Center, Helen Hayes Hospital, West Haverstraw, NY. Electronic address: cosmanf@helenhayeshosp.org.Colorado Center for Bone Research, Lakewood, CO.Radius Health Inc, Waltham, MA.Radius Health Inc, Waltham, MA.Radius Health Inc, Waltham, MA.Center for Clinical and Basic Research, Tallinn, Estonia.Radius Health Inc, Waltham, MA.Nordic Bioscience, Copenhagen, Denmark.Nordic Bioscience, Copenhagen, Denmark.Columbia University Medical Center, New York, NY.University of California at San Francisco School of Medicine.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28160873

Citation

Cosman, Felicia, et al. "Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed By 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial." Mayo Clinic Proceedings, vol. 92, no. 2, 2017, pp. 200-210.
Cosman F, Miller PD, Williams GC, et al. Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial. Mayo Clin Proc. 2017;92(2):200-210.
Cosman, F., Miller, P. D., Williams, G. C., Hattersley, G., Hu, M. Y., Valter, I., Fitzpatrick, L. A., Riis, B. J., Christiansen, C., Bilezikian, J. P., & Black, D. (2017). Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial. Mayo Clinic Proceedings, 92(2), 200-210. https://doi.org/10.1016/j.mayocp.2016.10.009
Cosman F, et al. Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed By 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial. Mayo Clin Proc. 2017;92(2):200-210. PubMed PMID: 28160873.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Eighteen Months of Treatment With Subcutaneous Abaloparatide Followed by 6 Months of Treatment With Alendronate in Postmenopausal Women With Osteoporosis: Results of the ACTIVExtend Trial. AU - Cosman,Felicia, AU - Miller,Paul D, AU - Williams,Gregory C, AU - Hattersley,Gary, AU - Hu,Ming-Yi, AU - Valter,Ivo, AU - Fitzpatrick,Lorraine A, AU - Riis,Bente Juel, AU - Christiansen,Claus, AU - Bilezikian,John P, AU - Black,Dennis, PY - 2016/07/22/received PY - 2016/09/17/revised PY - 2016/10/04/accepted PY - 2017/2/6/entrez PY - 2017/2/6/pubmed PY - 2017/6/1/medline SP - 200 EP - 210 JF - Mayo Clinic proceedings JO - Mayo Clin Proc VL - 92 IS - 2 N2 - OBJECTIVE: To assess the efficacy and safety of 18 months of subcutaneous abaloparatide (ABL-SC) or placebo (PBO) followed by 6 months of alendronate (ALN) (preplanned interim analysis). PATIENTS AND METHODS: ACTIVExtend, an extension of ACTIVE, enrolled patients who completed 18 months of ABL-SC or PBO in ACTIVE to receive up to 24 additional months of open-label ALN; there was 1 month between the studies to re-consent patients. RESULTS: Of 1243 eligible ACTIVE patients, 1139 (92%) were enrolled in ACTIVExtend beginning November 20, 2012. These results are from a prespecified 6-month interim analysis (cutoff date, June 2, 2015); the study is ongoing. Findings indicated percentages of patients with new morphometric vertebral fractures: PBO/ALN, 4.4% vs ABL-SC/ALN, 0.55%; relative risk reduction, 87% (relative risk, 0.13; 95% CI, 0.04-0.41; P<.001). Kaplan-Meier estimated rates of nonvertebral fractures were PBO/ALN, 5.6% vs ABL-SC/ALN, 2.7%; risk reduction, 52% (hazard ratio [HR], 0.48; 95% CI, 0.26-0.89; log-rank P=.02). There was also a 58% risk reduction of major osteoporotic fractures (HR, 0.42; 95% CI, 0.21-0.85; log-rank P=.01) and a 45% risk reduction of clinical fractures (HR, 0.55; 95% CI, 0.33-0.92; log-rank P=.02) in the ABL-SC/ALN group vs the PBO/ALN group. At 25 months, bone mineral density percentage change from ACTIVE baseline for ABL-SC/ALN vs PBO/ALN was as follows: lumbar spine, 12.8%; total hip, 5.5%; femoral neck, 4.5% vs 3.5%, 1.4%, 0.5%, respectively (group differences at all sites P<.001). CONCLUSION: Use of ABL-SC for 18 months followed by ALN for 6 months improved bone mineral density and reduced fracture risk throughout the skeleton and may be an effective treatment option for postmenopausal women with osteoporosis. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01657162. SN - 1942-5546 UR - https://www.unboundmedicine.com/medline/citation/28160873/Eighteen_Months_of_Treatment_With_Subcutaneous_Abaloparatide_Followed_by_6_Months_of_Treatment_With_Alendronate_in_Postmenopausal_Women_With_Osteoporosis:_Results_of_the_ACTIVExtend_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0025-6196(16)30630-9 DB - PRIME DP - Unbound Medicine ER -