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Sponsor ID
20080389

An Ascending Multiple Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density

Sponsor ID
20080389
Clinicaltrials.gov ID
NCT01101048
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
AMG 167
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
74
Additional Study Details

Protocol Summary

Primary Outcome Measures

The number (percent) of subjects experiencing clinically significant changes in safety laboratory tests, physical examinations, vital signs, or electrocardiograms (ECGs)

Timeframe: 168, 252, or 336 days following initial investigational product administration

The number (percent) of subjects reporting treatment-emergent adverse events

Timeframe: 168, 252, or 336 days following initial investigational product administration

The number (percent) of subjects who develop anti-AMG 167 antibodies

Timeframe: 168, 252, or 336 days following initial investigational product administration

Secondary Outcome Measures

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

Timeframe: 168, 252, or 336 days following initial investigational product administration

Pharmacokinetics

Timeframe: 168, 252, or 336 days following initial investigational product administration

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
45 - 75 Years
Condition
  • Bone Pain
    • Sex
    All
    Trial Dates
    Jun 2010 - Feb 2012
    Inclusion and Exclusion Criteria
    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 Exclusion Criteria for Cohort 7 Sub-study (Transition to Alendronate): - Contraindicated or intolerant of alendronate therapy