Prolia Efficacy Data

Fracture incidence and BMD data

Fracture Risk Reduction

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Fracture incidence with Prolia treatment over 10 years in postmenopausal osteoporosis1

Spine Icon

New vertebral fractures

Prolia

placebo

Vertebral Fracture Chart
Hip Fracture Icon

Hip fractures

Prolia

placebo

Hip Fracture Chart
Nonvertebral Fracture Risk Reduction Icon

Non-vertebral fractures

Prolia

placebo

Nonvertebral Fracture Chart

BMD data with Prolia treatment over 10 years in postmenopausal osteoporosis1

Spine Icon

Lumbar spine BMD

Bone Mineral Density

Lumbar Spine Chart
Pelvis Bone Icon

Total hip BMD

Bone Mineral Density

Total Hip Chart
Femoral Neck Icon

Femoral neck BMD

Bone Mineral Density

Femoral Neck Chart

ARR=absolute risk reduction; BMD=bone mineral density; FRR=fracture risk reduction; RRR=relative risk reduction
* Annualized yearly subject incidence.
† A randomized, double-blind, placebo-controlled study evaluating fracture reduction in postmenopausal patients with osteoporosis receiving 60 mg Prolia (n=3,902) or placebo (n=3,906) subcutaneously once every 6 months for 3 years. Subjects were between the ages of 60 and 90 years and had bone mineral density T-scores < -2.5 and ≥ -4.0. All women received at least 1000 mg calcium and at least 400 IU vitamin D supplementation per day. The primary endpoint was incidence of new vertebral fractures during the entire 36-month treatment period. Times to first hip and nonvertebral fracture were secondary endpoints. The percentages of nonvertebral, hip and new clinical vertebral fractures were cumulative Kaplan-Meier estimates for 3,902 subjects in the Prolia group and 3,906 in the placebo group. In the long-term, open-label extension study, women received Prolia for up to 10 years.1
‡ In women who received Prolia in the 3-year placebo-controlled phase and continued on therapy in the open-label extension of the FREEDOM study.1

Additional Resources

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FREEDOM Clinical Trial

Access the FREEDOM trial in the virtual library.

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Product Monograph

Download the Prolia Product Monograph in the virtual library.

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References
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