FREEDOM Trial | Prolia Treatment | Amgen

10 YEARS OF PROLIA® IS ASSOCIATED WITH SUSTAINED LOW INCIDENCE OF FRACTURES AT ALL SITES1

The FREEDOM trial and open-label extension demonstrated that Prolia® is effective when taken for 10 years. Patients who took Prolia® for 3 years displayed a relative risk reduction of 68% for vertebral fracture, 20% for non-vertebral fracture, and 40% for hip fracture vs placebo. The study extension showed that Prolia® treatment is associated with a sustained low incidence of fractures in postmenopausal women over an additional 7 years of treatment.1
Find out more about FREEDOM below, or download further information here.
Yearly incidence of new vertebral, non-vertebral and hip fractures during FREEDOM and extension. Percentages for new vertebral fractures are crude incidence, and percentages for non-vertebral and hip fractures are Kaplan-Meier estimates.1,2
*Lateral radiographs (lumbar and thoracic) were not obtained at extension years 4, 7, and 9. Incidences for vertebral fracture at these time points are annualized incidence (2-year incidence/2).
Click here to find out more about how Prolia® continuously increases BMD without therapeutic plateau.
FREEDOM was a multicentre, randomized, double-blind, placebo-controlled Phase III trial with extension up to 10 years.1

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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
Efficacy Graph
The objectives of the 3-year FREEDOM trial were to evaluate the efficacy of Prolia® against placebo in the reduction of vertebral, 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 and P1NP)
  • Bone biopsy findings (including bone histology and actual values of histomorphometric parameters) in a subset of patients

References:
BMD: bone mineral density; P1NP: procollagen type 1 N-terminal propeptide; Q6M: every 6 months; RRR: relative risk reduction; SC: subcutaneous; sCTx-1: serum C-terminal telopeptide of type 1 collagen.
  1. Bone HG, et al. Lancet Endocrinol Diabetes. 2017;5:513–23.
  2. Cummings SR, et al. N Eng J Med. 2009;361:756–65.

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