A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: placebo; Drug: Denosumab

• Registration Number: NCT00089791
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-08-01
• Study First Submitted: 2004-08-13
• Study First Submitted QC: 2004-08-13
• Study First Posted: 2004-08-16
• Primary Completion: 2008-06-17
• Study Completion: 2008-06-17
• Disposition First Submitted: 2009-11-23
• Disposition First Submitted QC: 2009-11-23
• Disposition First Posted: 2009-11-25
• Results First Submitted: 2010-07-02
• Results First Submitted QC: 2013-11-22
• Results First Posted: 2014-01-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7808

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo administered subcutaneously once every 6 months for 3 years.
Denosumab 60 mg Q6M	Denosumab	Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.

Primary Outcome Measures

Name	Time	Method
Number of Participants With New Vertebral Fractures	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 \[or both\] indica...

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Hip Fracture	36 months	Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.
Number of Participants With Nonvertebral Fractures	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...