Phase III ACTIVExtend trial shows Tymlos plus alendronate benefits in osteoporosis.- Radius Health.

Radius Health has presented response rates for bone mineral density (BMD) in osteoporosis patients treated with Tymlos (abaloparatide) followed by Alendronate from the phase III ACTIVExtend trial. In ACTIVExtend, patients who had completed 18 months of abaloparatide injection or placebo in the ACTIVE Phase III trial were transitioned to receive 24 additional months of open-label alendronate, a bisphosphonate.

BMD was measured at the lumbar spine, total hip, and femoral neck from the beginning of ACTIVE to the end of ACTIVExtend. A responder was defined as a patient with BMD increases at all three sites. BMD response rates increased in both the abaloparatide followed by alendronate group and the placebo followed by alendronate group from ACTIVE baseline through the 43 months of ACTIVExtend. In addition, there were significantly greater BMD response rates in the abaloparatide followed by alendronate group vs. the placebo followed by alendronate group at all three sites combined for BMD increases of more than 0 percent, 3 percent, and 6 percent at 43 months and at each anatomic site for BMD increases of more than 3 percent and 6 percent at each visit and at 43 months.

At the 43-month timepoint, 60.7 percent (n=307/506) of abaloparatide followed by alendronate patients experienced BMD increases of more than 3 percent at all three sites compared with 24 percent (n=121/505) of patients who received placebo followed by alendronate. Increases of more than 6 percent at all three sites were experienced by 33.2 percent (n=168/506) of abaloparatide followed by alendronate patients compared with 4 percent (n=20/505) of patients who received placebo followed by alendronate. Results were presented at ENDO 2018, the Endocrine Society�s 100th Annual Meeting and Expo in Chicago.