A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
This study has been completed.
Information provided by (Responsible Party):
First received: August 13, 2004
Last updated: November 22, 2013
Last verified: November 2013
This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)|
Resource links provided by NLM:
MedlinePlus related topics: Fractures Hip Injuries and Disorders Osteoporosis Spine Injuries and DisordersU.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Number of Participants With New Vertebral Fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]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).
Secondary Outcome Measures:
- Number of Participants With Nonvertebral Fractures [ Time Frame: 36 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.
|Study Start Date:||August 2004|
|Study Completion Date:||July 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
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
Contacts and Locations