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

Osteopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101048
• Other study ID #: 20080389
• Status: Completed
• Phase: Phase 1
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: September 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Drug:
• Placebo
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.
• AMG 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The number (percent) of subjects reporting treatment-emergent adverse events		168, 252, or 336 days following initial investigational product administration
Primary	The number (percent) of subjects who develop anti-AMG 167 antibodies		168, 252, or 336 days following initial investigational product administration
Secondary	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
Secondary	Pharmacokinetics		168, 252, or 336 days following initial investigational product administration

External Links

•   AmgenTrials clinical trials website