Prolia vs Placebo | Osteoporosis Treatment | Amgen

PROLIA® SIGNIFICANTLY REDUCES FRACTURE RISK ACROSS KEY SKELETAL SITES AFTER 3 YEARS VERSUS PLACEBO1

The FREEDOM study was a Phase III, multicentre, randomized, double-blind placebo-controlled trial with an extension up to 10 years.1,2 Women between the ages of 60 and 90 years (n=7,808) were randomly assigned (1:1) to receive 60 mg subcutaneous Prolia® or placebo.1
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.2
The FREEDOM trial demonstrated that patients who received Prolia® for 3 years displayed a relative risk reduction of 20% for non-vertebral fractures, 40% for hip fractures and 68% for vertebral fractures vs placebo.2
Find out more about FREEDOM below, or download further information here.
Reduction in various types of fractures by means of Prolia treatment as compared to placebo.
Percentage changes are calculated using cumulative Kaplan-Meier estimates for both Prolia® and placebo across the 3 years of treatment.2
For non-vertebral fracture: Hazard rate (HR) = 0.80 (95% CI; 0.67–0.95); hip fracture 0.60 (0.37–0.97); vertebral fracture 0.32 (0.26–0.41).

PROLIA® IS ASSOCIATED WITH SIGNIFICANT REDUCTIONS IN FRACTURE RATES IN THE REAL WORLD3

A real-world, observational, retrospective study conducted using claims data from Medicare in the USA calculated the incidence risk reduction of osteoporotic fractures observed among women aged over 65 years who were using Prolia®.3
A total of 34,622 users were included in the data set. Compared with the early treatment period, incidence rates of any fracture and clinical vertebral fracture decreased during the on-treatment period by 32% and 51%, respectively. Corresponding IRRs were 0.68 (95% CI: 0.62-0.75) and 0.49 (95% CI: 0.41-0.58), respectively.3
Percentage reduction in any fracture and reduction in vertebral fracture.

READ MORE

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 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

References:
*Any fracture was a composite endpoint of fracture at any skeletal site other than the skull, face, fingers, or toes.
Decreases in fracture incidence rates during the on-treatment period compared with the early treatment period.
ARR: absolute risk reduction; CI: confidence interval; IRR: incidence rate reduction; RRR: relative risk reduction; SHR: sub-hazard ratio.
  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.
  3. Yusuf AA, et al. Arch Osteoporos. 2018;13:33.

SMPC

The information contained in this site is for healthcare professionals only

I am a patient
I am a member of the public