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Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01575834
First received: April 4, 2012
Last updated: May 9, 2017
Last verified: April 2017
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Purpose
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis
| Condition | Intervention | Phase |
|---|---|---|
| Postmenopausal Osteoporosis | Drug: Romosozumab Drug: Placebo Drug: Denosumab | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoporosis
Drug Information available for:
Denosumab
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Incidence of vertebral fracture [ Time Frame: 12 Months ]
- Incidence of vertebral fracture [ Time Frame: 24 Months ]
Secondary Outcome Measures:
- Incidence of Fracture [ Time Frame: 12 Months ]
- Changes In Bone Mineral Density from Baseline to 12 Months [ Time Frame: 12 Months ]
- Incidence of Fracture [ Time Frame: 24 Months ]
- Changes In Bone Mineral Density from Baseline to 24 Months [ Time Frame: 24 Months ]
| Enrollment: | 7180 |
| Actual Study Start Date: | March 15, 2012 |
| Study Completion Date: | December 28, 2016 |
| Primary Completion Date: | December 14, 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Romosozumab
Participants received 210 mg romosozumab subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
|
Drug: Romosozumab
Administered by subcutaneous injection once a month (QM)
Other Names:
Drug: Denosumab
Administered by subcutaneous injection once every 6 months (Q6M)
Other Name: Prolia®
|
|
Placebo Comparator: Placebo
Participants received placebo subcutaneous injections once a month for 12 months, followed by 60 mg denosumab subcutaneously once every 6 months for 24 months.
|
Drug: Placebo
Administered by subcutaneous injection once a month (QM)
Drug: Denosumab
Administered by subcutaneous injection once every 6 months (Q6M)
Other Name: Prolia®
|
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score at the total hip or femoral neck of ≤ -2.50)
Exclusion Criteria:
- BMD T-score of ≤ -3.50 at the total hip or femoral neck
- History of hip fracture
- Any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays
- Use of agents affecting bone metabolism
- History of metabolic or bone disease (except osteoporosis)
- Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
- Current hyper- or hypocalcemia
- Current, uncontrolled hyper- or hypothyroidism
- Current, uncontrolled hyper- or hypoparathyroidism
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575834
Show 243 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575834
Show 243 Study Locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01575834 History of Changes |
| Other Study ID Numbers: |
20070337 2011-001456-11 ( EudraCT Number ) |
| Study First Received: | April 4, 2012 |
| Last Updated: | May 9, 2017 |
Keywords provided by Amgen:
|
Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Denosumab Bone Density Conservation Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 21, 2017