Romosozumab Followed by Alendronate Bests Alendronate Alone for Fracture Prevention

[Presentation title: A Randomised, Alendronate-Controlled Trial of Romosozumab: Results of the Phase 3 Active-Controlled Fracture Study in Postmenopausal Women with Osteoporosis at High Risk. Abstract 318]

In postmenopausal women with osteoporosis who are a high risk for fracture, romosozumab treatment for 12 months followed by alendronate resulted in a significantly lower fracture risk than alendronate alone, according to a study presented here at the 2017 Annual Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).

The findings are from the phase 3 ARCH study, in which 4,093 patients were randomised to receive monthly subcutaneous romosozumab 210 mg or weekly oral alendronate in a blinded manner for 12 months, followed by open-label alendronate in both groups. The primary analysis was done after clinical fractures had been confirmed in ≥330 patients.

Results showed that 12 months of romosozumab prior to alendronate versus alendronate alone significantly decreased new vertebral, clinical, nonvertebral, and hip fractures.

Over a period of 24 months, the incidence of new vertebral fractures was observed in 4.1% of patients who received romosozumab followed by alendronate versus 8.0% of patients who received only alendronate (adjusted P < .001). Clinical fractures occurred in 9.7% and 13.0% of patients, respectively (adjusted P < .001).

Nonvertebral fractures were documented in 8.7% and 10.6% (P = .040) and hip fractures in 2.0% and 3.2% of the 2 groups, respectively.

All patients in the study were postmenopausal women with osteoporosis at high risk for fracture defined as a hip bone mineral density (BMD) T-score of ≤-2.5 and a vertebral fracture OR a hip BMD T-score of ≤-2.0 and a recent hip fracture or 2 vertebral fractures.

The primary endpoints were the cumulative incidence of new vertebral fracture at 24 months and the cumulative incidence of clinical fracture at the time of the primary analysis.

Treatment with romosozumab led to rapid and significant gains in BMD at all sites measured at months 12 and 24 versus alendronate alone.

During the first year, positively adjudicated serious cardiovascular adverse events were documented more frequently with romosozumab than with alendronate (2.5% vs 1.9%).

During the open-label alendronate period, adjudicated events of osteonecrosis of the jaw (1 event in each group) and atypical femoral fracture (2 events in the romosozumab group and 4 events in the alendronate only group) were noted.

Kenneth Saag, MD, University of Alabama at Birmingham, Birmingham, Alabama, and said that the overall results show that the sequence of romosozumab followed by an antiresorptive therapy may provide significant benefits for the treatment of osteoporosis in women at high risk for fracture.

Funding for this study was provided by Amgen.

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