Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)
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ClinicalTrials.gov Identifier: NCT01575834 |
Recruitment Status
:
Completed
First Posted
: April 12, 2012
Last Update Posted
: May 10, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postmenopausal Osteoporosis | Drug: Romosozumab Drug: Placebo Drug: Denosumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7180 participants |
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 |
Actual Study Start Date : | March 15, 2012 |
Actual Primary Completion Date : | December 14, 2015 |
Actual Study Completion Date : | December 28, 2016 |

Arm | Intervention/treatment |
---|---|
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.
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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®
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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.
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Drug: Placebo
Administered by subcutaneous injection once a month (QM)
Drug: Denosumab
Administered by subcutaneous injection once every 6 months (Q6M)
Other Name: Prolia®
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- Incidence of vertebral fracture [ Time Frame: 12 Months ]
- Incidence of vertebral fracture [ Time Frame: 24 Months ]
- 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 ]

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Ages Eligible for Study: | 55 Years to 90 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575834

Study Director: | MD | Amgen |
Additional Information:
Publications:
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01575834 History of Changes |
Other Study ID Numbers: |
20070337 2011-001456-11 ( EudraCT Number ) |
First Posted: | April 12, 2012 Key Record Dates |
Last Update Posted: | May 10, 2017 |
Last Verified: | April 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 |
Metabolic Diseases Denosumab Bone Density Conservation Agents Physiological Effects of Drugs |