Transition From Alendronate to Romosozumab (AMG 785)

Amgen

Status and phase

Completed

Phase 1

Conditions

Osteoporosis

Treatments

Drug: Romosozumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01588509

20110253

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

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)