New Osteoporosis Drug Developments Offer Solutions for Postmenopausal Women

A number of studies presented at the 2017 EULAR Congress highlighted recent advancements in existing drug classes and new drug classes for the treatment of osteoporosis in postmenopausal women.  

A study presented by Piet Geusens, MD, PhD,  of the department of internal medicine within the division of rheumatology at the CAPHRI School for Public Health and Primary Care at the Maastricht University Medical Center in The Netherlands, discussed the benefits of Tymlos (abaloparatide; Radius) and romosozumab (Amgen).

“[Tymlos] and romosozumab are new bone forming agents, with different effects on bone remodeling and remodeling and early effects on clinical fractures,” Dr Geusens wrote. “This opens new perspectives in individualized treatment of patients with high fracture risk and for fracture prevention in patients with low bone turnover, multiple vertebral fractures, very low bone mineral density and fractures, or bone loss during anti-resorptive treatment.”

His presentation highlighted two recent clinical trials. He noted that in one of the trials, Tymlos reduced the risk of vertebral fractures by 86%, clinical fractures by 43%, nonvertebral fractures by 43%, and major fractures by 70%. 

According to the presentation, the second clinical trial found that romosozumab reduced the risk of vertebral fractures by 63% and clinical fractures by 36% during the first year. Dr Geusens said that this effect was continued after 1 year of treatment with Xgeva (denosumab; Amgen).

A second abstract presented by Dr Geusens and colleagues at the 2017 EULAR Congress showed that romosozumab significantly reduced spine fracture risk among postmenopausal women. 

“These results support this new class of drug as a highly effective treatment for postmenopausal women with osteoporosis with established bone mineral density deficit who are at increased risk of fracture,” Dr Geusens said in a press release. “The rapid and large reduction in clinical vertebral fracture risk is an important and highly relevant clinical outcome.”

He outlined the results of the Fracture Study in Postmenopausal Women with Osteoporosis (FRAME) study, a randomized, double-blind, placebo-controlled, parallel-group trial that included a cohort of 7180 postmenopausal women. The researchers administered monthly romosozumab to an intervention group of 3589 patients and placebo to a control group of 3591 patients for 1 year.

Study results showed that there were three
patients in the control group with clinical vertebral fractures compared with 17 in the placebo group. This translated to a risk reduction of 83% in the control group at 1 year.

Dr Geusens also outlined the formulary decision-making process for osteoporosis medications during a separate session at the conference. 

“The clinical pathway for fracture prevention consists of a five-step approach: case finding, risk evaluation, differential diagnosis, treatment, and follow up,” he explained. “For each of these steps, new insights have emerged during the last year.” —David Costill