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Study Complete
Sponsor ID
20070337

Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With OsteoporosisFRAME

Sponsor ID
20070337
Clinicaltrials.gov ID
NCT01575834
EUCTIS ID
N/A
EudraCT ID
2011-001456-11
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Study Details

The purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis

Additional Study Details

Phase
Phase 3
Product
AMG 785
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
7180
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of vertebral fracture

Timeframe: 12 Months

Incidence of vertebral fracture

Timeframe: 24 Months

Secondary Outcome Measures

Incidence of Fracture

Timeframe: 12 Months

Changes In Bone Mineral Density from Baseline to 12 Months

Timeframe: 12 Months

Incidence of Fracture

Timeframe: 24 Months

Changes In Bone Mineral Density from Baseline to 24 Months

Timeframe: 24 Months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Bethesda, MD, United States, 20817
Status
Completed
Location
Research Site
Denton, TX, United States, 76210-8625
Status
Completed
Location
Research Site
Detroit, MI, United States, 48236
Status
Completed
Location
Research Site
Gainesville, GA, United States, 30501
Status
Completed
Location
Research Site
Laguna Hills, CA, United States, 92653
Status
Completed
Location
Research Site
Lakewood, CO, United States, 80227
Status
Completed
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Study Info
Age
55 - 90 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Mar 2012 - Dec 2015
    Inclusion and Exclusion 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