Fracture Reduction

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.
AMG_BrandAdvance_Key skeletal sites
Percentage changes are calculated using cumulative Kaplan-Meier estimates for both Prolia® and placebo across the 3 years of treatment.2

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
AMG_Realworlddata_Yusuf

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.

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