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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01575834
First received: April 4, 2012
Last updated: May 9, 2017
Last verified: April 2017
  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: 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:


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:
  • 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®

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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
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 July 24, 2017