A Study to Evaluate Denosumab in the Tr… | Clinical Trial

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis, Postmenopausal

Age range

60 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo administered by subcutaneous injection

Denosumab

Drug

Denosumab 60 mg administered by subcutaneous injection

Other names: AMG 162, Prolia®

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Aug 16, 2004
Registry last updated: Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed