Transition From Alendronate to AMG 785

Condition(s) targeted: OSTEOPOROSIS, POSTMENOPAUSAL

Intervention: AMG 785 Dose 1 (Drug); AMG 785 Dose 2 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

This is a phase 1, randomized, open-label, parallel group study conducted in healthy postmenopausal women with low bone mineral density previously treated with alendronate.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in lumbar spine bone mineral density (BMD)

Secondary outcome:

Change in total hip and femoral neck BMD

Change in serum type 1 aminoterminal propeptide (P1NP) measurements

Number of treatment-emergent adverse events to include clinically significant changes in chemistry, hematology, physical examinations, electrocardiograms, and incidences of subjects who develop anti-AMG 785 antibodies

Mean (SD) serum concentration of AMG 785

Change in serum C-telopeptide (sCTX) measurements

Minimum age: 55 Years. Maximum age: 85 Years. Gender(s): Female.

Criteria:

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)

Research Site, Tucson, Arizona 85711, United States

Research Site, Walnut Creek, California 94598, United States

Research Site, Gainesville, Georgia 30501, United States

Research Site, Honolulu, Hawaii 96813, United States

Research Site, Bethesda, Maryland 20817, United States

Research Site, Albuquerque, New Mexico 87106, United States

Research Site, West Haverstraw, New York 10993, United States

Research Site, Wyomissing, Pennsylvania 19610, United States

Research Site, Seattle, Washington 98144, United States

AmgenTrials clinical trials website

Starting date: March 2012
Last updated: October 10, 2013