FDA approves abaloparatide for men with osteoporosis at high risk for fracture
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The FDA has approved abaloparatide, a parathyroid hormone-related peptide analog, to increase bone mineral density among men with osteoporosis at high risk for fracture, according to an industry press release.
Abaloparatide (Tymlos, Radius Health) was approved based on the findings from the phase 3 Abaloparatide Treatment for Men (ATOM) study. As Healio previously reported at the 2022 AACE Annual Scientific and Clinical Conference, abaloparatide was associated with greater increases in BMD at the lumbar spine, total hip and femoral neck compared with placebo at 3, 6 and 12 months among a cohort of men with osteoporosis. For the study’s primary endpoint of change in BMD at the lumbar spine from baseline to 12 months, the abaloparatide group had an 8.5% BMD increase compared with 1.2% for the placebo group (P < .0001).
Abaloparatide’s approval is for men with osteoporosis at high risk for fracture, which is defined as having either a history of osteoporotic fracture or multiple risk factors for fracture. The agent has also been approved for men for whom osteoporosis therapies have failed or who are intolerant to other osteoporosis therapies.
“Thirty percent of all hip fractures occur in men, and approximately 25% of men over the age of 50 years will sustain an osteoporotic-related fracture,” Bruce Mitlak, MD, Chief Medical Officer at Radius Health, said in a press release. “Additionally, while the overall prevalence of fragility fractures is higher in women, men generally have higher rates of fracture-related mortality.”
The FDA approval comes more than 5 years after abaloparatide was approved for postmenopausal women. As Healio previously reported, the FDA approved abaloparatide for postmenopausal women with osteoporosis at high risk for fracture in April 2017 after findings from the ACTIVE trial revealed the agent reduced the relative risks for new vertebral fractures in women by 86% and for nonvertebral fractures by 43% compared with placebo.
For men, the five most common adverse reactions reported with abaloparatide are injection site erythema in 13%, dizziness in 9%, arthralgia in 7%, injection site swelling in 7% and injection site pain in 6%. These differ from the five most common adverse events reported by women, which are hypercalciuria (11%), dizziness (10%), nausea (8%), headache (8%) and palpitations (5%), according to the release.
Perspective
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E. Michael Lewiecki, MD, FACE, FACP
Prior to FDA approval of abaloparatide for the treatment of men with osteoporosis at high risk for fracture, there was only one approved anabolic agent for men — teriparatide. A second anabolic option for men is a welcome addition to our toolbox for treating men at high risk.
Abaloparatide increased bone mineral density more than open-label teriparatide in the pivotal fracture trial in women, suggesting it may do the same for men. BMD increases among men treated with abaloparatide exceeded the surrogate threshold values for predicting fracture risk reduction. No new safety concerns were observed, with several of the most common adverse events similar to what has been reported in women.
Accumulating data supports the use of an anabolic agent as initial therapy in high-risk patients, to be followed by an antiresorptive medication, rather than the reverse sequence of therapy. Men with osteoporosis are underdiagnosed and undertreated, even more so than women. The large osteoporosis treatment gap represents a crisis in patient care. Men with very low BMD and men with a prior fracture, especially a recent one, should be considered for initial therapy with an anabolic agent.
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