FREEDOM was a 3-year trial and was extended up to 10 years. A total of 7,808 postmenopausal women were enrolled and randomly assigned (1:1) to receive either 60 mg subcutaneous Prolia® or placebo every 6 months. In the extension, 4,550 women were enrolled to continue to receive long-term Prolia®.1
The objectives of the 3-year FREEDOM trial were to evaluate the efficacy of Prolia® against placebo in the reduction of vertebral fractures (primary endpoint), and non-vertebral and hip fractures. Secondary endpoints included changes in BMD, changes in bone turnover markers (sCTx-1 and P1NP), and the incidence of adverse events.2
The primary objective of the 7-year FREEDOM extension was to monitor the long-term safety of Prolia®. This included assessments of adverse event incidence and serious adverse event incidence, changes in laboratory analytes (i.e. serum chemistry and haematology), and participant incidence of denosumab antibody formation.1
Secondary outcomes included:1
- New vertebral, non-vertebral and hip fractures
- BMD changes at the lumbar spine, total hip, femoral neck, and one-third distal radius
- Changes in bone turnover markers (sCTx-1, P1NP and bone-specific alkaline phosphatase)
- Bone biopsy findings (including bone histology and actual values of histomorphometric parameters) in a subset of patients