Clinical trial NCT00089791: A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
Official title: A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Postmenopausal Osteoporosis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-08-16
Enrollment: 7808
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Participants With New Vertebral Fractures
timeFrame: 36 months
Secondary outcomes:
measure: Number of Participants With Nonvertebral Fractures
timeFrame: 36 months
measure: Number of Participants With a Hip Fracture
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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