Status:
COMPLETED
An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women
Lead Sponsor:
Amgen
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
55-90 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2015
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT01796301
Start Date
January 31 2013
End Date
May 14 2015
Last Update
November 29 2022
Active Locations (50)
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1
Research Site
Gainesville, Georgia, United States, 30501
2
Research Site
Bethesda, Maryland, United States, 20817
3
Research Site
Boston, Massachusetts, United States, 02114
4
Research Site
Boston, Massachusetts, United States, 02131