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

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Placebo

AMG 167

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring Amgen, Phase 1b, Postmenopausal, Bone Mineral Density

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

A

B

Arm Description

Two (2) women in each of cohorts 1 and 4, and two (2) men in cohort 2 will receive placebo every 2 weeks for a total of 6 doses. Two (2) women in each of cohorts 3 and 5, and two (2) men in cohort 6 will receive placebo every 4 weeks for a total of 3 doses. Six (6) women in cohort 7 will receive placebo every 2 weeks for a total of 12 doses. In addition, subjects in cohorts 4 have the option to receive an additional 6 doses of placebo; subjects in cohorts 5 and 6 have the option to receive an additional 3 doses. Subjects in cohort 7 have the option to transition to 6 months of alendronate treatment.

Six (6) women in each of cohorts 1 and 4, and six (6) men in cohort 2 will receive AMG 167 every 2 weeks for a total of 6 doses. Six (6) women in each of cohorts 3 and 5, and six (6) men in cohort 6 will receive AMG 167 every 4 weeks for a total of 3 doses. Eighteen (18) women in cohort 7 will receive AMG 167 every 2 weeks for a total of 12 doses. In addition, subjects in cohorts 4 have the option to receive an additional 6 doses of AMG 167; subjects in cohorts 5 and 6 have the option to receive an additional 3 doses. Subjects in cohort 7 have the option to transition to 6 months of alendronate treatment.

Outcomes

Primary Outcome Measures

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

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

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

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

Pharmacokinetics

Full Information

NCT ID

NCT01101048

First Posted

April 8, 2010

Last Updated

September 4, 2018

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01101048

Brief Title

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

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteopenia

Keywords

Amgen, Phase 1b, Postmenopausal, Bone Mineral Density

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A

Arm Type

Placebo Comparator

Arm Description

Two (2) women in each of cohorts 1 and 4, and two (2) men in cohort 2 will receive placebo every 2 weeks for a total of 6 doses. Two (2) women in each of cohorts 3 and 5, and two (2) men in cohort 6 will receive placebo every 4 weeks for a total of 3 doses. Six (6) women in cohort 7 will receive placebo every 2 weeks for a total of 12 doses. In addition, subjects in cohorts 4 have the option to receive an additional 6 doses of placebo; subjects in cohorts 5 and 6 have the option to receive an additional 3 doses. Subjects in cohort 7 have the option to transition to 6 months of alendronate treatment.

Arm Title

B

Arm Type

Active Comparator

Arm Description

Six (6) women in each of cohorts 1 and 4, and six (6) men in cohort 2 will receive AMG 167 every 2 weeks for a total of 6 doses. Six (6) women in each of cohorts 3 and 5, and six (6) men in cohort 6 will receive AMG 167 every 4 weeks for a total of 3 doses. Eighteen (18) women in cohort 7 will receive AMG 167 every 2 weeks for a total of 12 doses. In addition, subjects in cohorts 4 have the option to receive an additional 6 doses of AMG 167; subjects in cohorts 5 and 6 have the option to receive an additional 3 doses. Subjects in cohort 7 have the option to transition to 6 months of alendronate treatment.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

AMG 167

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame