FREEDOM Trial | Osteoporosis Treatment

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

$Percentage reduction in any fracture and reduction in vertebral fracture.$

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

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.

Bone HG, et al. Lancet Endocrinol Diabetes. 2017;5:513–23.
Cummings SR, et al. N Eng J Med. 2009;361:756–65.
Yusuf AA, et al. Arch Osteoporos. 2018;13:33.

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

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

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

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