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Abaloparatide is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared with Teriparatide.
Calcif Tissue Int. 2018 11; 103(5):540-545.CT

Abstract

Abaloparatide (ABL) is a 34-amino acid peptide designed to be a selective activator of the parathyroid hormone receptor type 1 signaling pathway. In the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE), subcutaneous ABL reduced the risk of new vertebral, nonvertebral, clinical, and major osteoporotic fracture compared with placebo and of major osteoporotic fracture compared with teriparatide. To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data. To estimate the potential effectiveness of ABL in populations at higher fracture risk than in ACTIVE, we calculated NNT for vertebral fracture using reference populations from historical placebo-controlled trials, assuming an 86% relative risk reduction in vertebral fracture with ABL treatment as observed in ACTIVE. NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE. The projected NNT for ABL in other populations was calculated based on incidence rate (IR) for vertebral fractures in the placebo arms of the FREEDOM (placebo IR 7.2%), FIT-1 (placebo IR 15.0%), and FIT-2 (placebo IR 3.8%) trials. NNT for ABL in ACTIVE was 28 for vertebral, 55 for nonvertebral, 37 for clinical, and 34 for major osteoporotic fracture. NNT for these fracture types for teriparatide in ACTIVE were 30, 92, 59, and 75, respectively. Using placebo IRs from FREEDOM, FIT-1, and FIT-2, projected NNTs for vertebral fracture with ABL were 17, 8, and 31. These data are useful for further evaluating ABL for the treatment of osteoporosis in postmenopausal women.

Authors+Show Affiliations

Université de Liège, Place du 20-Ao슩t, 7, 4000, Liège, Belgium.Radius Health, Inc., 950 Winter St, Waltham, MA, 02451, USA. ghattersley@radiuspharm.com.Radius Health, Inc., 950 Winter St, Waltham, MA, 02451, USA.Radius Health, Inc., 950 Winter St, Waltham, MA, 02451, USA.Radius Health, Inc., 950 Winter St, Waltham, MA, 02451, USA.New Mexico Clinical Research & Osteoporosis Center, Inc., 300 Oak St, SE, Albuquerque, NM, 87106, USA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29951742

Citation

Reginster, Jean-Yves, et al. "Abaloparatide Is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared With Teriparatide." Calcified Tissue International, vol. 103, no. 5, 2018, pp. 540-545.
Reginster JY, Hattersley G, Williams GC, et al. Abaloparatide is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared with Teriparatide. Calcif Tissue Int. 2018;103(5):540-545.
Reginster, J. Y., Hattersley, G., Williams, G. C., Hu, M. Y., Fitzpatrick, L. A., & Lewiecki, E. M. (2018). Abaloparatide is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared with Teriparatide. Calcified Tissue International, 103(5), 540-545. https://doi.org/10.1007/s00223-018-0450-0
Reginster JY, et al. Abaloparatide Is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared With Teriparatide. Calcif Tissue Int. 2018;103(5):540-545. PubMed PMID: 29951742.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Abaloparatide is an Effective Treatment Option for Postmenopausal Osteoporosis: Review of the Number Needed to Treat Compared with Teriparatide. AU - Reginster,Jean-Yves, AU - Hattersley,Gary, AU - Williams,Gregory C, AU - Hu,Ming-Yi, AU - Fitzpatrick,Lorraine A, AU - Lewiecki,E Michael, Y1 - 2018/06/27/ PY - 2018/05/16/received PY - 2018/06/22/accepted PY - 2018/6/29/pubmed PY - 2019/9/17/medline PY - 2018/6/29/entrez KW - ACTIVE trial KW - Abaloparatide KW - Fracture risk reduction KW - Number needed to treat KW - Postmenopausal osteoporosis SP - 540 EP - 545 JF - Calcified tissue international JO - Calcif Tissue Int VL - 103 IS - 5 N2 - Abaloparatide (ABL) is a 34-amino acid peptide designed to be a selective activator of the parathyroid hormone receptor type 1 signaling pathway. In the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE), subcutaneous ABL reduced the risk of new vertebral, nonvertebral, clinical, and major osteoporotic fracture compared with placebo and of major osteoporotic fracture compared with teriparatide. To further evaluate the effectiveness of ABL, we calculated the number needed to treat (NNT) to prevent one fracture using ACTIVE data. To estimate the potential effectiveness of ABL in populations at higher fracture risk than in ACTIVE, we calculated NNT for vertebral fracture using reference populations from historical placebo-controlled trials, assuming an 86% relative risk reduction in vertebral fracture with ABL treatment as observed in ACTIVE. NNT was calculated as the reciprocal of the absolute risk reduction in ACTIVE. The projected NNT for ABL in other populations was calculated based on incidence rate (IR) for vertebral fractures in the placebo arms of the FREEDOM (placebo IR 7.2%), FIT-1 (placebo IR 15.0%), and FIT-2 (placebo IR 3.8%) trials. NNT for ABL in ACTIVE was 28 for vertebral, 55 for nonvertebral, 37 for clinical, and 34 for major osteoporotic fracture. NNT for these fracture types for teriparatide in ACTIVE were 30, 92, 59, and 75, respectively. Using placebo IRs from FREEDOM, FIT-1, and FIT-2, projected NNTs for vertebral fracture with ABL were 17, 8, and 31. These data are useful for further evaluating ABL for the treatment of osteoporosis in postmenopausal women. SN - 1432-0827 UR - https://www.unboundmedicine.com/medline/citation/29951742/Abaloparatide_is_an_Effective_Treatment_Option_for_Postmenopausal_Osteoporosis:_Review_of_the_Number_Needed_to_Treat_Compared_with_Teriparatide_ L2 - https://dx.doi.org/10.1007/s00223-018-0450-0 DB - PRIME DP - Unbound Medicine ER -