Abaloparatide increases BMD, improves bone turnover markers in men with osteoporosis
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SAN DIEGO — Men with osteoporosis receiving daily injections of abaloparatide had greater increases in bone mineral density at the lumbar spine, total hip and femoral neck at 12 months compared with placebo, according to a speaker.
As Healio previously reported, abaloparatide (Tymlos, Radius Health) was approved by the FDA in April 2017 for the treatment of postmenopausal women with osteoporosis and a high risk for fractures. In new findings from a phase 3 study presented at the AACE Annual Scientific and Clinical Conference, abaloparatide was associated with improvements in BMD and in bone turnover markers in men with either primary or hypogonadism-associated osteoporosis, making it a potential treatment option for men, according to Neil Binkley, MD, professor in the department of medicine – division of geriatrics and gerontology, co-director of the osteoporosis clinical center and research program, and associate director for the Institute on Aging at the University of Wisconsin-Madison.
“We’re not doing a good in treating women with osteoporosis, and we’re doing a poorer job in men,” Binkley said during a presentation. “About one-third to half of men who sustain osteoporosis fractures have a bone density test and receive treatment. The treatment gap among men is even larger, and as such, it’s appropriate that there are more studies of medications to treat osteoporosis in men to reduce the risk for fracture.”
Binkley and colleagues enrolled 218 men with osteoporosis to participate in a randomized double-blind controlled phase 3 trial. Participants were randomly assigned 2:1 to daily injections of 80 g of abaloparatide or placebo for 12 months. The study’s primary endpoint was the percent change of lumbar spine BMD from baseline to 12 months, with secondary endpoints including the change in total hip and femoral neck BMD from baseline to 12 months, incidences of new clinical fractures at 12 months, log ratio of serum procollagen type I N-terminal propeptide (s-PINP) and serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX) at 1, 3, 6 and 12 months over baseline, and safety and adverse events.
At 3, 6 and 12 months, men receiving abaloparatide had significantly greater increases in BMD at the lumbar spine, total hip and femoral neck compared with placebo. There were very few fractures reported in either group, with one participant in the abaloparatide group and three in the placebo group sustaining a fracture during the study.
Significantly greater increases in s-PINP and s-CTX were observed in the abaloparatide group compared with baseline at 3, 6 and 12 months. Median s-PINP peaked at 111.17 ng/mL at 1 month in the abaloparatide group and was at 85.7 ng/mL at 12 months. Median s-CTX peaked at 0.476 ng/mL at 6 months and was similar at 0.448 ng/mL at 12 months.
The most common treatment-emergent adverse events were erythema at the injection site, nasopharyngitis and dizziness. There were eight serious adverse events in the treatment group compared with four in placebo, and no deaths associated with treatment in the trial were reported.
“In men with osteoporosis, treatment with abaloparatide resulted in significant and prompt improvements in BMD at the spine, the femoral neck and the total hip in comparison to placebo,” Binkley said. “It was safe and well tolerated. This suggests that abaloparatide will be an effective treatment for men with osteoporosis.”
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Czerwinski E, et al. Efficacy and safety of abaloparatide in men with osteoporosis. Presented at: American Association of Clinical Endocrinology Annual Scientific and Clinical Conference; May 12-14, 2022; San Diego.
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