Long term Denosumab Use Shows Favorable Outcomes: Results from the FREEDOM Extension Trial Save

Osteoporosis is a disease characterized by increased bone loss that outpaces the grown of new bone. As a result bones become less dense and more fragile and brittle; porous bones are more prone to fracture. In fact, 1 in 3 women and 1 in 5 men are at risk of an osteoporotic fracture.

Bisphosphonates and denosumab are well established therapies for osteoporosis. Although most of the time treatment with bisphosphonates and denosumab is well tolerated, long term safety and efficacy data has been lacking

The FREEDOM pivotal study (ClinicalTrials.gov: NCT00089791) has demonstrated that gains in BMD with denosumab treatment for up to 3 years were associated with increased estimated bone strength.

Of the 7808 women enrolled in the FREEDOM study, 4550 (77%) enrolled in The FREEDOM Extension - a large ongoing study designed to evaluate the long-term benefit/risk of denosumab treatment for osteoporosis. The 8 year study results revealed sustained reduction of bone turnover, continued gains in BMD at each time point measured (3 years, 5 years and 8 years), and continued low yearly fracture incidence. The overall safety profile of denosumab in this ongoing study remains consistent over time, indicating a favorable balance between benefit and risk through 8 years of treatment.