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Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01575834
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Romosozumab Drug: Placebo Drug: Denosumab Phase 3

Study Design

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
Primary Completion Date : December 14, 2015
Study Completion Date : December 28, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
Drug Information available for: Denosumab
U.S. FDA Resources

Arms and Interventions

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.
Drug: Romosozumab
Administered by subcutaneous injection once a month (QM)
Other Names:
  • AMG 785
  • EVENITY™
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®


Outcome Measures

Primary Outcome Measures :
  1. Incidence of vertebral fracture [ Time Frame: 12 Months ]
  2. Incidence of vertebral fracture [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. Incidence of Fracture [ Time Frame: 12 Months ]
  2. Changes In Bone Mineral Density from Baseline to 12 Months [ Time Frame: 12 Months ]
  3. Incidence of Fracture [ Time Frame: 24 Months ]
  4. Changes In Bone Mineral Density from Baseline to 24 Months [ Time Frame: 24 Months ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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


  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 )
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