A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
|ClinicalTrials.gov Identifier: NCT00089791|
Recruitment Status : Completed
First Posted : August 16, 2004
Results First Posted : January 10, 2014
Last Update Posted : June 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: placebo Drug: Denosumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7808 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)|
|Actual Study Start Date :||August 1, 2004|
|Actual Primary Completion Date :||May 1, 2008|
|Actual Study Completion Date :||July 1, 2008|
Placebo Comparator: Placebo
Placebo administered subcutaneously once every 6 months for 3 years.
Placebo administered by subcutaneous injection
Experimental: Denosumab 60 mg Q6M
Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
Denosumab 60 mg administered by subcutaneous injection
- Number of Participants With New Vertebral Fractures [ Time Frame: 36 months ]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).
- Number of Participants With Nonvertebral Fractures [ Time Frame: 36 months ]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.
- Number of Participants With a Hip Fracture [ Time Frame: 36 months ]Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089791