Clinical trial NCT01101048: An Ascending Multiple Dose Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density
Official title: A Randomized, Double-blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 167 in Healthy Men and Postmenopausal Women With Low Bone Mineral Density
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteopenia
Keywords: Amgen
Phase 1b
Postmenopausal
Bone Mineral Density
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2010-04-09
Enrollment: 74
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
measure: The number (percent) of subjects reporting treatment-emergent adverse events
timeFrame: 168, 252, or 336 days following initial investigational product administration
measure: The number (percent) of subjects who develop anti-AMG 167 antibodies
timeFrame: 168, 252, or 336 days following initial investigational product administration
Secondary outcomes:
measure: 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
measure: Pharmacokinetics
timeFrame: 168, 252, or 336 days following initial investigational product administration
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: