Advanced age is an important risk factor for fracture. The ACTIVE ( Abaloparatide Comparator Trial In Vertebral Endpoints ) trial has shown that subcutaneous Abaloparatide ( Tymlos ) increased bone mineral density ( BMD ) and has reduced the risk of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis.
The effects of Abaloparatide in the subgroup of women aged 80 or more years in ACTIVE were reported.
Researchers have carried out a post hoc analysis 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 trial.
The mean ages of the women greater than or equal to 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 less than 0.001 ), 3.6% at the femoral neck ( P less than 0.01 ), and 12.1% at the lumbar spine ( P less than 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.
In conclusion, Abaloparatide was effective in increasing bone mineral density in the very elderly subgroup of ACTIVE, with a safety profile similar to that of the overall study population. ( Xagena )
McClung MR et al, Menopause 2018; Epub ahead of print