Abaloparatide followed by alendronate treatment may improve bone mineral density (BMD) in women with postmenopausal osteoporosis and type 2 diabetes (T2D), according to study results presented at the 28th Annual Congress of the American Association of Clinical Endocrinologists, held April 24 to 28, 2019, in Los Angeles, California.
Previously, abaloparatide treatment was shown to significantly improve BMD and reduce risk for new vertebral, nonvertebral, clinical, and major osteoporotic fractures, compared with placebo in the ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) study, with similar results in a post-hoc analysis of women with T2D.
ACTIVExtend was an extension study in which participants received open-label alendronate for 24 months after completing 18 months of abaloparatide or placebo (total treatment period of 43 months because of an additional 1 month for reconsent). In this post-hoc analysis, the researchers investigated the outcomes of abaloparatide followed by alendronate (abaloparatide/alendronate) compared with placebo followed by alendronate (placebo/ alendronate) in the subgroup of women with T2D.
The ACTIVExtend study enrolled 558 patients in the abaloparatide/alendronate group and 581 patients in the placebo/alendronate group. The cohort included 61 patients with T2D in the abaloparatide/alendronate group and 64 patients with T2D in the placebo/alendronate group (median age, 70 years; mean femoral neck T-score, -2.26).
At 43 months, the rate of new vertebral fractures was not significantly different between the group receiving abaloparatide/alendronate (0%) and the group receiving placebo/alendronate (3.2%). Similarly, there was a numerical but not statistically significant difference in estimated incidence of nonvertebral fractures (3.4% vs 10.1%, respectively), clinical fractures (6.7% vs 10.1%, respectively), and major osteoporotic fractures (1.7% vs 6.9%, respectively) with abaloparatide/alendronate and placebo/alendronate.
The researchers identified significant increases in BMD from baseline at the total hip (mean change of 6.3% with abaloparatide/alendronate vs 1.7% with placebo/alendronate), femoral neck (4.7% vs 1.0%, respectively), and lumbar spine (15.9% vs 6.9%, respectively).
“This post hoc analysis suggests that [abaloparatide] followed by [alendronate] may provide a valuable treatment sequence for women with postmenopausal osteoporosis and [T2D] at high risk for fracture,” concluded the investigators.
Dhaliwal R, Mitalk B, Fitzpatrick L, et al. Effect of abaloparatide followed by alendronate on bone mineral density and fracture incidence in postmenopausal women with osteoporosis and type 2 diabetes mellitus. Presented at: American Association of Clinical Endocrinologists 28th Annual Scientific & Clinical Congress; April 24-28, 2019; Los Angeles, CA.