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Study Complete
Sponsor ID
20080289

An Open-label Study to Evaluate the Effect of Treatment with Romosozumab or Teriparatide in Postmenopausal WomenSTRUCTURE

Sponsor ID
20080289
Clinicaltrials.gov ID
NCT01796301
EUCTIS ID
N/A
EudraCT ID
2012-002948-24
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Study Details

The primary objective of the study was to evaluate the effect of 12 months of treatment with romosozumab compared with teriparatide on total hip bone mineral density (BMD) in postmenopausal women with osteoporosis who were previously treated with bisphosphonate therapy.

Additional Study Details

Phase
Phase 3
Product
AMG 785
Type
Interventional
Masking
None (Open Label)
Enrollment
436
Additional Study Details

Protocol Summary

Primary Outcome Measures

The primary endpoint is the percent change from baseline in DXA BMD at the total hip through Month 12.

Timeframe: Through Month 12

Secondary Outcome Measures

Percent change from baseline in BMD by DXA at the total hip at Month 6, and M12.

Timeframe: Month 6 and Month 12

Percent change from baseline in cortical BMD by QCT at the total hip at Month 6 and M 12,

Timeframe: Month and Month 12

Percent change from baseline in integral BMD by QCT at the total hip at Month 6 and M 12

Timeframe: Month 6 and Month 12

Percent change from baseline in estimated strength by FEA at the total hip at Month 6 and M 12

Timeframe: Month 6 and Month 12

Study Documents

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

Locations

Location
Status
Contact Us
Location
Research Site
Bethesda, MD, United States, 20817
Status
Recruiting
Location
Research Site
Gainesville, GA, United States, 30501
Status
Recruiting
Location
Research Site
Quebec, QC, Canada, G1V 3M7
Status
Recruiting
Location
Research Site
Vancouver, BC, Canada, V6H 3X8
Status
Recruiting
Location
Research Site
Detroit, MI, United States, 48236
Status
Completed
Location
Research Site
Aarhus C, Denmark, 8000
Status
Recruiting
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Study Info
Age
55 - 90 Years
Condition
  • Osteoporosis
    • Sex
    Assigned Female at Birth
    Trial Dates
    Jan 2013 - May 2015
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Postmenopausal women, aged ≥ 55 to ≤ 90. - Received oral bisphosphonate therapy for at least 3 years immediately prior to screening - BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck - History of nonvertebral fracture after age 50, or vertebral fracture.
    Exclusion Criteria:
    - Use of other agents affecting bone metabolism including Strontium ranelate, fluoride (for osteoporosis), odanacatib (MK-0822) or any other cathepsin K inhibitor, IV bisphosphonates, denosumab, teriparatide (TPTD) or any parathyroid hormone (PTH) analogs, Systemic oral or transdermal estrogen, selective estrogen receptor modulators (SERMs), activated vitamin D3, vitamin K2, calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids: - History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of study results, such as sclerosteosis, Paget’s disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia, and malabsorption syndrome. - Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL, as determined by the central laboratory. - Current hyper- or hypocalcemia - Current, uncontrolled hyper- or hypothyroidism