CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7,808 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
Denosumab 60 mg subcutaneous injection every 6 monthsAI-extracted
Key inclusion· 2
  • ✓Women aged 60 to 90 years
  • ✓Bone mineral density T-Score at hip or spine less than –2.5
Key exclusion· 2
  • ✕BMD T-Score at hip or spine less than –4.0
  • ✕Severe vertebral fracture or more than two moderate vertebral fractures on spinal x-ray

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00089791
NCT00089791Phase 3Completed
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A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)

Amgen·interventional·Posted Aug 16, 2004·Updated Nov 8, 2022

In Brief

A Phase 3 clinical trial evaluating placebo and Denosumab for Osteoporosis. Completed, enrolled 7,808 participants.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 16, 2004
Enrollment StartAug 1, 2004
Primary CompletionJun 17, 2008
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 21.9 years ago

Interventions

placebodrug

Placebo administered by subcutaneous injection

Denosumabdrug

Denosumab 60 mg administered by subcutaneous injection