Radius Health announced new data from the ACTIVExtend study evaluating fracture risk reductions in postmenopausal women receiving Tymlos (abaloparatide) injection. The full findings were presented at the ASBMR 2017 Annual Meeting, in Denver, CO.
Patients who completed 18 months of treatment with Tymlos or placebo in the Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial (n=2463) were transitioned to receive 24 months of open-label alendronate in ACTIVExtend. The data showed a statistically significant fracture risk reduction through 3.5 years.
Specifically, female patients previously treated with Tymlos demonstrated an 84% relative risk reduction (P <.0001) in the incidence of new vertebral fractures at Month 43 vs those who received placebo followed by alendronate. Treatment with Tymlos followed by alendronate led to a 39% relative risk reduction in nonvertebral fractures (P =.038) vs those who received placebo followed by alendronate.
In addition, a separate exploratory analysis found a statistically significant risk reduction in hip fractures in Tymlos-treated patients who were transitioned to alendronate vs those who received placebo followed by alendronate. The 5 hip fractures observed across the trial all occurred among patients treated with placebo + alendronate.
Lead author, Henry G. Bone, MD, FACP, FACEl, from St John Hospital and Medical Center, Detroit, MI, stated, “In the ACTIVExtend trial, the increased bone mass and reduced fracture risk achieved with abaloparatide were maintained and extended with alendronate, a low cost antiresorptive agent.”
Tymlos, a human parathryoid hormone related peptide (PTHrP [1–34]) analog, is approved to treat postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. It is available as a 3120mcg/1.56mL strength single-use prefilled pen.
Radius health presents positive data for TYMLOS™ (abaloparatide) injection from the ACTIVExtend trial at ASBMR 2017 annual meeting [press release]. Waltham, MA: Radius. http://ir.radiuspharm.com/releasedetail.cfm?ReleaseID=1039744. Published September 10, 2017. Accessed October 3, 2017.
This article originally appeared on MPR