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Study Complete
Sponsor ID
20110142

Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women with OsteoporosisARCH

Sponsor ID
20110142
Clinicaltrials.gov ID
NCT01631214
EUCTIS ID
N/A
EudraCT ID
2011-003142-41
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Study Details

The purpose of this study is to determine if treatment 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
4093
Additional Study Details

Protocol Summary

Primary Outcome Measures

Incidence of clinical fracture

Timeframe: From baseline until the date of first clinical fracture assessed (approximately 24 months)

Incidence of new vertebral fracture

Timeframe: 24 months

Secondary Outcome Measures

Incidence of fracture

Timeframe: 12 months

Percent changes in DXA Bone Mineral Density from baseline to 12 months

Timeframe: 12 months

Incidence of fracture

Timeframe: From baseline until the date of first clinical fracture assessed (approximately 24 months)

Percent changes in DXA Bone Mineral Density from baseline to 24 months

Timeframe: 24 Months

Percent changes in DXA Bone Mineral Density from baseline to 36 months

Timeframe: 36 Months

Study Documents

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

Locations

Location
Status
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Location
Research Site
Walnut Creek, CA, United States, 94598
Status
Recruiting
Location
Research Site
Scottsdale, AZ, United States, 85258
Status
Completed
Location
Research Site
Vancouver, BC, Canada, V5Z 4E1
Status
Recruiting
Location
Research Site
Detroit, MI, United States, 48236
Status
Completed
Location
Research Site
Phoenix, AZ, United States, 85037
Status
Recruiting
Location
Research Site
Siena, Italy, 53100
Status
Recruiting
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Study Info
Age
55 - 90 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    May 2012 - Feb 2017
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Postmenopausal women who meet at least one of the following bone mineral density (BMD) and fracture criteria: • BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER: - at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral fracture OR - at least 2 mild (SQ1) vertebral fractures OR • BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER: - at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR - a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization.
    Exclusion Criteria:
    - 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 - Possible signs of intolerance to alendronate