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 16, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: placebo
Drug: Denosumab
Phase 3

Study Type: Interventional
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:


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.


Enrollment: 7808
Study Start Date: August 2004
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo administered subcutaneously once every 6 months for 3 years.
Drug: placebo
Placebo administered by subcutaneous injection
Experimental: Denosumab 60 mg Q6M
Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
Drug: Denosumab
Denosumab 60 mg administered by subcutaneous injection
Other Names:
  • AMG 162
  • Prolia®

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089791

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00089791     History of Changes
Other Study ID Numbers: 20030216
Study First Received: August 13, 2004
Results First Received: July 2, 2010
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Postmenopausal Osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 22, 2014