Transitioning from 18 months of treatment with abaloparatide (Tymlos; Radius Health) to 24 months of open-label alendronate was found to increase bone mineral density (BMD) by ≥3% the at the lumbar spine, total hip, and femoral neck in a majority (60.7%) of postmenopausal women with osteoporosis.
The findings come from the ACTIVExtend trial, an extension of the ACTIVE trial, which compared abaloparatide and placebo over 18 months in 2,463 postmenopausal women with osteoporosis. In ACTIVExtend, patients who completed 18 months of abaloparatide or placebo in ACTIVE were administered open-label alendronate for up to 24 additional months. A responder was defined as a patient with BMD increases at all 3 sites.
At the 43-month endpoint, a total of 60.7% of the abaloparatide followed by alendronate group had ≥3% BMD increase at all 3 sites (P<0.0001) vs 24% of the placebo followed by alendronate group. Moreover, 33.2% of the abaloparatide group experienced a ≥6% BMD increase at all 3 sites vs 4% of the placebo group (P<0.0001).
“These findings support the belief that sequential treatment with abaloparatide followed by alendronate may result in consistent gains in bone mass,” said Chad Deal, MD, Head of the Center for Osteoporosis and Metabolic Bone Disease at Cleveland Clinic, and lead author of the study.
Tymlos currently approved to treat postmenopausal women with osteoporosis at high risk for fracture, defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.
Full findings, including risk subgroup information, will be presented at the ENDO 2018 annual meeting in Chicago.
For more information visit Endo2018.com.