Transition From Alendronate to Romosozumab (AMG 785)
Completed · Phase 1
Conditions studied: Osteoporosis
In brief
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated with alendronate.
Key facts
- Study ID
- NCT01588509
- Run by
- Amgen
- People needed
- 60
- Starts
- 2012-03-30
- Expected to finish
- 2012-11-21
- Last updated by the study team
- 2019-03-26
Who can join
Age: 55 and older, up to 85. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months
- Low bone mineral density at screening [defined by a bone mineral density (BMD) T-score ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable vertebrae), total hip, or femoral neck]
- Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year with verbal agreement that the subject has taken ≥ 80% of their doses with good tolerance
You may not qualify if…
- History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or pelvis after age 50; or recent bone fracture within 6 months prior to screening
- History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
- Vitamin D deficiency (defined as 25-OH-VitD levels < 20 ng/mL)
Where it is running
- Research Site — Tucson, Arizona, United States
- Research Site — Walnut Creek, California, United States
- Research Site — Gainesville, Georgia, United States
- Research Site — Honolulu, Hawaii, United States
- Research Site — Bethesda, Maryland, United States
- Research Site — Albuquerque, New Mexico, United States
- Research Site — West Haverstraw, New York, United States
- Research Site — Wyomissing, Pennsylvania, United States
- Research Site — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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