A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis
This study has been completed.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00089791
First received: August 13, 2004
Last updated: June 24, 2010
Last verified: June 2010
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Purpose
This study will evaluate the effectiveness and safety of denosumab in treating women with Postmenopausal Osteoporosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis |
Drug: placebo Drug: denosumab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months) |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Reduction in the number of new vertebral fractures in post menopausal osteoporotic women treated with denosumab compared to placebo and to characterize safety and tolerability profile of denosumab. [ Time Frame: 36 month treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess effect of denosumab on time to first non-vertebral fracture and time to first hip fracture. [ Time Frame: 36 month treatment period ] [ Designated as safety issue: No ]
| Enrollment: | 7200 |
| Study Start Date: | August 2004 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: II
3600 postmenopausal women with osteoporosis
|
Drug: placebo
Placebo SC every 6 months. Subjects will take daily calcium (at least 1 g) and vitamin D (at least 400 IU) supplementation.
|
|
Experimental: I
3600 postmenopausal women with osteoporosis
|
Drug: denosumab
denosumab 60 mg SC every 6 months. Subjects will take daily calcium (at least 1 g) and vitamin D (at least 400 IU) supplementation.
|
Eligibility| Ages Eligible for Study: | 60 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Women who are 60 to 90 years of age may be eligible to participate
- 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
- Subjects with any severe or more than two moderate vertebral fractures on spinal x-ray at entry
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089791
Show 182 Study Locations
Show 182 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00089791 History of Changes |
| Other Study ID Numbers: | 20030216 |
| Study First Received: | August 13, 2004 |
| Last Updated: | June 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Postmenopausal Osteoporosis |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013