Michael R McClung1,2, Nicholas C Harvey3, Lorraine A Fitzpatrick4, Paul D Miller5, Gary Hattersley4, Yamei Wang4, Felicia Cosman6,7. 1. Oregon Osteoporosis Center, Portland, OR. 2. Institute of Health and Ageing, Australian Catholic University, Melbourne, Australia. 3. MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, United Kingdom. 4. Radius Health, Inc., Waltham, MA. 5. Colorado Center for Bone Research, Lakewood, CO. 6. Helen Hayes Hospital, West Haverstraw, NY. 7. Columbia University, New York, NY.
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 theplacebo (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.
RCT Entities:
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: S Boonen; J D Adachi; Z Man; S R Cummings; K Lippuner; O Törring; J C Gallagher; J Farrerons; A Wang; N Franchimont; J San Martin; A Grauer; M McClung Journal: J Clin Endocrinol Metab Date: 2011-03-16 Impact factor: 5.958
Authors: Paul D Miller; Gary Hattersley; Bente Juel Riis; Gregory C Williams; Edith Lau; Luis Augusto Russo; Peter Alexandersen; Cristiano A F Zerbini; Ming-yi Hu; Alan G Harris; Lorraine A Fitzpatrick; Felicia Cosman; Claus Christiansen Journal: JAMA Date: 2016-08-16 Impact factor: 56.272
Authors: A C Looker; H W Wahner; W L Dunn; M S Calvo; T B Harris; S P Heyse; C C Johnston; R L Lindsay Journal: Osteoporos Int Date: 1995 Impact factor: 4.507
Authors: Felicia Cosman; Gary Hattersley; Ming-Yi Hu; Gregory C Williams; Lorraine A Fitzpatrick; Dennis M Black Journal: J Bone Miner Res Date: 2016-09-28 Impact factor: 6.741
Authors: P Dargent-Molina; F Favier; H Grandjean; C Baudoin; A M Schott; E Hausherr; P J Meunier; G Bréart Journal: Lancet Date: 1996-07-20 Impact factor: 79.321
Authors: Steven Boonen; Dennis M Black; Cathleen S Colón-Emeric; Richard Eastell; Jay S Magaziner; Erik Fink Eriksen; Peter Mesenbrink; Patrick Haentjens; Kenneth W Lyles Journal: J Am Geriatr Soc Date: 2010-01-08 Impact factor: 5.562