In women older than 80 years, treatment with abaloparatide is associated with significantly increased bone mineral density (BMD) of the lumbar spine and proximal femur and fewer vertebral and nonvertebral fractures, according to the results of a subgroup analysis of the Abaloparatide Comparator Trial In Vertebral Endpoints (ACTIVE) study published in Menopause.
Using data from the phase 3, double-blind, randomized, controlled ACTIVE trial, the investigators conducted a post hoc analysis of BMD and fracture incidence in women ≥80 years who were treated with abaloparatide (n=51) or placebo (n=43). Mean patient age was 81.7 years in the abaloparatide group and 81.9 years in the placebo group.
Significant increases in BMD from baseline to 18 months were reported with abaloparatide therapy — 3.9% at the total hip (P <.001), 3.6% at the femoral neck (P< .01), and 12.1% at the lumbar spine (P <.001) — that were similar to the increases observed in the general population. Treatment with abaloparatide was associated with numerical, but not statistically significant, reductions in the risk for vertebral and nonvertebral fractures compared with placebo.
The percentage of participants who reported adverse events was similar in both the abaloparatide and placebo groups, as well as in older participants and the general population.
The investigators concluded that treatment with abaloparatide was effective in increasing BMD in this elderly subgroup of patients from the ACTIVE trial, with a safety profile that was similar to that of the overall study population. As life expectancy is on the rise, it is important to develop therapeutic options that have the ability to reduce fractures in very old individuals in order to have a substantial impact on disability, loss of independence, and mortality from complications associated with osteoporosis.
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 [published online February 16, 2018]. Menopause. doi:10.1097/GME.0000000000001080