A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00089791
First received: August 13, 2004
Last updated: July 11, 2014
Last verified: July 2014

August 13, 2004
July 11, 2014
August 2004
May 2008   (final data collection date for primary outcome measure)
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).
Not Provided
Complete list of historical versions of study NCT00089791 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoporosis
  • Drug: placebo
    Placebo administered by subcutaneous injection
  • Drug: Denosumab
    Denosumab 60 mg administered by subcutaneous injection
    Other Names:
    • AMG 162
    • Prolia®
  • Placebo Comparator: Placebo
    Placebo administered subcutaneously once every 6 months for 3 years.
    Intervention: Drug: placebo
  • Experimental: Denosumab 60 mg Q6M
    Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
    Intervention: Drug: Denosumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7808
July 2008
May 2008   (final data collection date for primary outcome measure)

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
Female
60 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00089791
20030216
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP