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Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis.
Menopause. 2018 07; 25(7):767-771.M

Abstract

OBJECTIVE

Advanced age is an important risk factor for fracture. The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) trial showed that subcutaneous abaloparatide increased bone mineral density (BMD) and reduced the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis. This study describes the effects of abaloparatide in the subgroup of women aged 80 or more years in ACTIVE.

METHODS

Post hoc analyses of BMD and fracture incidence in this subgroup of women who received abaloparatide or placebo in the 18-month, phase 3, double-blind, randomized controlled ACTIVE trial.

RESULTS

The mean ages of the women ≥80 years were 81.9 and 81.7 years in the placebo (n = 43) and abaloparatide (n = 51) groups, respectively. The increases in BMD from baseline to 18 months with abaloparatide treatment were 3.9% at the total hip (P < 0.001), 3.6% at the femoral neck (P < 0.01), and 12.1% at the lumbar spine (P < 0.001), and were similar to those observed in the overall population. Abaloparatide therapy was associated with numerical, but not statistically significant, reductions in the risk of vertebral and nonvertebral fractures in this subpopulation, compared with placebo. The proportion of participants reporting adverse events was similar between treatment groups and between the older subgroup and the overall population.

CONCLUSION

Abaloparatide was effective in increasing BMD in the very elderly subgroup of ACTIVE, with a safety profile similar to that of the overall study population.

Authors+Show Affiliations

Oregon Osteoporosis Center, Portland, OR. Institute of Health and Ageing, Australian Catholic University, Melbourne, Australia.MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom.Radius Health, Inc., Waltham, MA.Colorado Center for Bone Research, Lakewood, CO.Radius Health, Inc., Waltham, MA.Radius Health, Inc., Waltham, MA.Helen Hayes Hospital, West Haverstraw, NY. Columbia University, New York, NY.

Pub Type(s)

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

Language

eng

PubMed ID

29462094

Citation

McClung, Michael R., et al. "Effects of Abaloparatide On Bone Mineral Density and Risk of Fracture in Postmenopausal Women Aged 80 Years or Older With Osteoporosis." Menopause (New York, N.Y.), vol. 25, no. 7, 2018, pp. 767-771.
McClung MR, Harvey NC, Fitzpatrick LA, et al. Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis. Menopause. 2018;25(7):767-771.
McClung, M. R., Harvey, N. C., Fitzpatrick, L. A., Miller, P. D., Hattersley, G., Wang, Y., & Cosman, F. (2018). Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis. Menopause (New York, N.Y.), 25(7), 767-771. https://doi.org/10.1097/GME.0000000000001080
McClung MR, et al. Effects of Abaloparatide On Bone Mineral Density and Risk of Fracture in Postmenopausal Women Aged 80 Years or Older With Osteoporosis. Menopause. 2018;25(7):767-771. PubMed PMID: 29462094.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of abaloparatide on bone mineral density and risk of fracture in postmenopausal women aged 80 years or older with osteoporosis. AU - McClung,Michael R, AU - Harvey,Nicholas C, AU - Fitzpatrick,Lorraine A, AU - Miller,Paul D, AU - Hattersley,Gary, AU - Wang,Yamei, AU - Cosman,Felicia, PY - 2018/2/21/pubmed PY - 2019/9/14/medline PY - 2018/2/21/entrez SP - 767 EP - 771 JF - Menopause (New York, N.Y.) JO - Menopause VL - 25 IS - 7 N2 - OBJECTIVE: Advanced age is an important risk factor for fracture. The Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) trial showed that subcutaneous abaloparatide increased bone mineral density (BMD) and reduced the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis. This study describes the effects of abaloparatide in the subgroup of women aged 80 or more years in ACTIVE. METHODS: Post hoc analyses of BMD and fracture incidence in this subgroup of women who received abaloparatide or placebo in the 18-month, phase 3, double-blind, randomized controlled ACTIVE trial. RESULTS: The mean ages of the women ≥80 years were 81.9 and 81.7 years in the placebo (n = 43) and abaloparatide (n = 51) groups, respectively. The increases in BMD from baseline to 18 months with abaloparatide treatment were 3.9% at the total hip (P < 0.001), 3.6% at the femoral neck (P < 0.01), and 12.1% at the lumbar spine (P < 0.001), and were similar to those observed in the overall population. Abaloparatide therapy was associated with numerical, but not statistically significant, reductions in the risk of vertebral and nonvertebral fractures in this subpopulation, compared with placebo. The proportion of participants reporting adverse events was similar between treatment groups and between the older subgroup and the overall population. CONCLUSION: Abaloparatide was effective in increasing BMD in the very elderly subgroup of ACTIVE, with a safety profile similar to that of the overall study population. SN - 1530-0374 UR - https://www.unboundmedicine.com/medline/citation/29462094/Effects_of_abaloparatide_on_bone_mineral_density_and_risk_of_fracture_in_postmenopausal_women_aged_80_years_or_older_with_osteoporosis_ L2 - https://doi.org/10.1097/GME.0000000000001080 DB - PRIME DP - Unbound Medicine ER -