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Study Complete
Sponsor ID
20030216

A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis

Sponsor ID
20030216
Clinicaltrials.gov ID
NCT00089791
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
7808
Additional Study Details

Protocol Summary

Primary Outcome Measures

New Vertebral Fracture

Timeframe: 36 months

Secondary Outcome Measures

Nonvertebral Fracture

Timeframe: 36 months

Hip Fracture

Timeframe: 36 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
60 - 90 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Aug 2004 - Jun 2008
    Inclusion and Exclusion 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