Osteopenia
Conditions
Keywords
Amgen, Phase 1b, Postmenopausal, Bone Mineral Density
Brief summary
The purpose of this study is to assess the safety, tolerability, and potential immune response of AMG 167 following multiple subcutaneous (SC, injection under the skin) dose administrations in healthy men and postmenopausal women with low bone mineral density.
Interventions
DRUGPlacebo
Subjects will be randomized to receive one of 3 doses of AMG 167 or equivalent volume of placebo administered at once every two-week or once every four-week dosing intervals. Postmenopausal women will receive AMG 167 in one of 3 fixed doses, while men will receive AMG 167 in one of 2 fixed doses by injection under the skin.
DRUGAMG 167
Subjects will be randomized to receive one of 3 doses of AMG 167 or equivalent volume of placebo administered at once every two-week or once every four-week dosing intervals. Postmenopausal women will receive AMG 167 in one of 3 fixed doses, while men will receive AMG 167 in one of 2 fixed doses by injection under the skin.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Low bone mineral density as determined at the time of screening \[as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4), or total evaluable vertebrae (if fewer than L1-L4); or femoral neck between -1.0 and -2.5, exclusive\] * 25-hydroxyvitamin D ≥ 20 ng/mL * Willing and able to take ≥ 1,000 mg elemental calcium and ≥ 800 IU (but ≤ 1,000 IU) vitamin D daily upon enrollment
Exclusion criteria
* Osteoporosis, as defined by BMD T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ 2.5 * History of vertebral fracture, or fragility fracture (a fracture resulting from no or minor trauma; ie, fall from standing height or less) of the wrist, humerus, hip, or pelvis after age 50 * Diagnosed with any condition that will affect bone metabolism * Diagnosis of clotting factor deficiency or history of bleeding or coagulation disorder * History of spinal stenosis * History of facial nerve paralysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number (percent) of subjects reporting treatment-emergent adverse events | 168, 252, or 336 days following initial investigational product administration |
| The number (percent) of subjects experiencing clinically significant changes in safety laboratory tests, physical examinations, vital signs, or electrocardiograms (ECGs) | 168, 252, or 336 days following initial investigational product administration |
| The number (percent) of subjects who develop anti-AMG 167 antibodies | 168, 252, or 336 days following initial investigational product administration |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic parameters [bone mineral density as assessed by dual energy X-ray absorptiometry (DXA), serum procollagen type 1 N-terminal propeptide (P1NP), osteocalcin, bone-specific alkaline phosphatase (BSAP), and serum CTX levels] and sclerostin | 168, 252, or 336 days following initial investigational product administration |
| Pharmacokinetics | 168, 252, or 336 days following initial investigational product administration |
Outcome results
None listed