Fracture-Risk Reduction Continues With Long-Term Denosumab

By Reuters Staff

June 13, 2019

NEW YORK (Reuters Health) - Extended treatment with denosumab is associated with continued reduction in nonvertebral fracture (NVF) rates, according to new findings.

"These data further support the long-term administration of denosumab, a potent antiresorptive therapy, in postmenopausal women with osteoporosis and a hip BMD T-score =<-1.5 to improve bone strength and minimize the risk of fragility fractures," Dr. Serge Ferrari of Geneva University Hospital in Switzerland and colleagues conclude in the Journal of Clinical Endocrinology and Metabolism, online May 24.

The three-year phase 3 FREEDOM trial found denosumab significantly reduced vertebral, nonvertebral and hip fracture risk in postmenopausal osteoporotic women compared to placebo.

In the FREEDOM Extension phase of the trial, more than 4,000 women from 172 centers continued on denosumab or switched to active treatment for seven years, including 2,343 on denosumab for the full 10-year study period and 1,731 who crossed over.

Overall, NVF rates were 2.15 in years 1-3 and 1.53 in years 4-7. Among women on long-term treatment, NVF rates were 1.98 in years 1-3 and1.44 in years 4-10.

The rate of osteonecrosis of the jaw was 0.05 (12 cases) and that of atypical femoral fracture 0.01 (2 cases) per 100 patient-years.

NVF would be expected to increase over time in untreated aging postmenopausal women, the authors note. "The findings in the current analysis are consistent with the notion that achieving higher BMD T-scores with denosumab treatment is associated with further reduction in nonvertebral fracture risk," they add.

"Taking into consideration the risk of vertebral fractures upon premature treatment discontinuation with further fracture risk reduction with long-term therapy, these observations emphasize the benefits and necessity of maintaining long-term treatment in high-risk patients," they conclude.

Amgen Inc., the maker of denosumab, funded the study, and two study authors are Amgen employees. Other study authors report consulting for or receiving research funding from the company.


J Clin Endocrinol Metab 2019.