ACTIVE: Abaloparatide increases BMD in oldest women subgroup
In women aged at least 80 years with osteoporosis, bone mineral density at the total hip, femoral neck and lumbar spine increased during 18 months with abaloparatide therapy compared with placebo, according to findings from the ACTIVE trial.
Gary Hattersley, PhD, chief scientific officer at Radius Health, and colleagues evaluated data from ACTIVE, an 18-month, phase 3, double-blind, randomized controlled trial, on a subgroup of postmenopausal women with osteoporosis aged at least 80 years randomly assigned to subcutaneous abaloparatide (Tymlos, Radius Health; mean age, 81.7 years; n = 51) or placebo (mean age, 81.9 years; n = 43) to determine the effect on BMD and the risk for vertebral and nonvertebral fractures.
Participants treated with abaloparatide had significant increases in BMD at the total hip from baseline to 6 months (2%; P < .01 compared with placebo). The abaloparatide group also experienced increases in BMD from baseline to 18 months at the total hip (3.9%; P < .001 compared with placebo), femoral neck (3.6%; P < .01 compared with placebo) and lumbar spine (12.1%; P < .001 compared with placebo).
These findings are similar to those that Endocrine Today previously reported from the whole trial cohort. Participants in the whole trial cohort assigned to abaloparatide compared with placebo had increases in BMD from baseline during the 18-month period at the total hip (4.18% vs. –0.1%), femoral neck (3.6% vs. –0.43%) and lumbar spine (11.2% vs. 0.63%).
Treatment emergent adverse events were similar between the subgroup population (86.3%) compared with the whole trial cohort (89.4%).
“These findings are consistent with efficacy of abaloparatide in the very elderly comparable to that in the general older population,” the researchers wrote. “As life expectancy is increasing and a growing proportion of individuals in the next 30 years will be in the at-risk older category, it will be important to further develop such therapeutic options that clearly reduce fractures in the very old if we hope to make a substantial impact on disability, loss of independence and mortality from complications of osteoporosis.” – by Amber Cox
Disclosures: Hattersley reports he is an employee of and owns company stock in Radius Health. Please see the study for all other authors’ relevant financial disclosures.