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A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

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ClinicalTrials.gov Identifier: NCT00089791
Recruitment Status : Completed
First Posted : August 16, 2004
Results First Posted : January 10, 2014
Last Update Posted : June 9, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: placebo Drug: Denosumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7808 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Actual Study Start Date : August 1, 2004
Primary Completion Date : May 1, 2008
Study Completion Date : July 1, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Denosumab
U.S. FDA Resources

Arm Intervention/treatment
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®

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089791

Sponsors and Collaborators
Study Director: MD Amgen

Additional Information:
Hadji P, Bock O, Resch H, Kraenzlin M, Wang A, Steinle T, Eisen C. Reduction of fracture risk with denosumab among women with osteoporosis with or without need for treatment according to DVO 2009 guideline : A subgroup analysis of the FREEDOM trial. Osteologie. 2013;22(1):39-45.

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
First Posted: August 16, 2004    Key Record Dates
Results First Posted: January 10, 2014
Last Update Posted: June 9, 2017
Last Verified: May 2017

Keywords provided by Amgen:
Postmenopausal Osteoporosis

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs