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Study Complete
Sponsor ID
20120156

A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis

Sponsor ID
20120156
Clinicaltrials.gov ID
NCT02016716
EUCTIS ID
N/A
EudraCT ID
2013-000434-35
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Study Details

The purpose of this study is to compare 2 formulations of romosozumab (AMG 785) on bone mineral density (BMD) in postmenopausal women with osteoporosis.

Additional Study Details

Phase
Phase 3
Product
AMG 785
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
294
Additional Study Details

Protocol Summary

Primary Outcome Measures

The primary endpoint is the percent change from baseline in DXA BMD at the lumbar spine (noninferiority)

Timeframe: 6 months

Secondary Outcome Measures

percent change from baseline in DXA BMD at the total hip

Timeframe: Month 6

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
Recruiting
Location
Research Site
Gainesville, GA, United States, 30501
Status
Recruiting
Location
Research Site
Katowice, Poland, 40-040
Status
Recruiting
Location
Research Site
Warszawa, Poland, 01-192
Status
Recruiting
Location
Research Site
Wroclaw, Poland, 50-088
Status
Recruiting
Location
Research Site
Gdynia, Poland, 81-384
Status
Recruiting
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Study Info
Age
55 - 90 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Dec 2013 - Sep 2014
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Postmenopausal women with osteoporosis at high risk for fracture defined as - BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck AND - a history of fragility fracture or at least 2 other risk factors
    Exclusion Criteria:
    - BMD T score < -3.50 at the total hip or femoral neck. - History of hip fracture. - History of metabolic or bone disease (except osteoporosis). - Use of agents affecting bone metabolism. - Vitamin D insufficiency. - History of solid organ or bone marrow transplants. - Hyper- or hypocalcemia. - Hyper- or hypothyroidism. - Hyper- or hypoparathyroidism.