A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

Study Overview
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Brief Summary
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This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.

Official Title
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A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: placebo
* Drug: Denosumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who are 60 to 90 years of age may be eligible to participate Bone mineral density (BMD) T-Score at hip or spine must be less than -2.5 Exclusion Criteria: BMD T-Score at the hip or the spine of less than -4.0 Patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo administered subcutaneously once every 6 months for 3 years. | Drug: placebo<br>* Placebo administered by subcutaneous injection<br>|
| Experimental: Denosumab 60 mg Q6M<br>Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years. | Drug: Denosumab<br>* Denosumab 60 mg administered by subcutaneous injection<br>* Other names: Prolia®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With New Vertebral Fractures | A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms [or both] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture). | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Nonvertebral Fractures | Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary. | 36 months | 
| Number of Participants With a Hip Fracture | Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal Osteoporosis