Transition From Alendronate to Romosozumab (AMG 785)

Status:	Completed
Conditions:	Osteoporosis, Postmenopausal Syndrome
Therapuetic Areas:	Endocrinology, Rheumatology
Healthy:	No
Age Range:	55 - 85
Updated:	3/28/2019
Start Date:	March 30, 2012
End Date:	November 21, 2012

An Open-label, Randomized Study to Estimate the Percent Change From Baseline in Lumbar Spine Bone Mineral Density After 3 Months of AMG 785 Administration in Postmenopausal Women With Low Bone Mineral Density Previously Treated With Alendronate

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

We found this trial at

sites

Clinical Trial Facility in Seattle Washington

Seattle, Washington 98105

964

from 91732

Seattle, WA