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A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women

Primary Purpose

Osteopenia

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Romosozumab

Placebo

About this trial

This is an interventional treatment trial for Osteopenia focused on measuring Amgen, Phase 1, Postmenopausal, Japanese

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese
Body mass index ≤ 25 kg/m², inclusive at screening
Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)

Exclusion Criteria:

Osteoporosis, 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 ≤ -2.5
History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis;
Diagnosed with any condition that will affect bone metabolism

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Romosozumab

Placebo

Arm Description

Japanese women in cohorts 1, 2, and 4 will receive a single dose of 1, 3, or 5 mg/kg romosozumab. Non-Japanese women in cohort 3 will receive a single dose of 3 mg/kg romosozumab.

Participants will receive a single dose of placebo.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

A serious adverse event (SAE) is defined as an adverse event that is fatal is life threatening requires in-patient hospitalization or prolongation of existing hospitalization results in persistent or significant disability/incapacity is a congenital anomaly/birth defect other significant medical hazard. A treatment-related AE is any treatment-emergent AE that per investigator review has a reasonable possibility of being caused by the investigational product.

Number of Participants Who Developed Anti-romosozumab Binding Antibodies

Participants who were negative for anti-romosozumab binding antibodies at baseline with a positive result at any time post-baseline.

Serum Calcium Levels

Serum Intact Parathyroid Hormone (iPTH) Levels

Secondary Outcome Measures

Maximum Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

Maximum Percent Change From Baseline in Serum C-telopeptide (CTX)

Percent Change From Baseline in Sclerostin

Time to Maximum Observed Concentration of Romosozumab

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Maximum Observed Concentration of Romosozumab

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Area Under the Serum Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Romosozumab

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Romosozumab

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Apparent Clearance (CL/F) of Romosozumab

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Full Information

NCT ID

NCT01101061

First Posted

April 8, 2010

Last Updated

July 29, 2019

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01101061

Brief Title

A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women

Official Title

A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Postmenopausal Japanese Women

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

May 3, 2010 (Actual)

Primary Completion Date

November 1, 2010 (Actual)

Study Completion Date

November 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

5. Study Description

Brief Summary

The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.

6. Conditions and Keywords

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

Osteopenia

Keywords

Amgen, Phase 1, Postmenopausal, Japanese

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Romosozumab

Arm Type

Experimental

Arm Description

Japanese women in cohorts 1, 2, and 4 will receive a single dose of 1, 3, or 5 mg/kg romosozumab. Non-Japanese women in cohort 3 will receive a single dose of 3 mg/kg romosozumab.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive a single dose of placebo.

Intervention Type

Drug

Intervention Name(s)

Romosozumab

Other Intervention Name(s)

AMG 785, EVENITY™

Intervention Description

Administered by subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered by subcutaneous injection

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Time Frame

Participants who received a 1 or 3 mg/kg dose (romosozumab or placebo) were followed for 2 months (day 57) after study drug administration and participants who received 5 mg/kg were followed for 3 months (day 85) for safety assessments.

Title

Number of Participants Who Developed Anti-romosozumab Binding Antibodies

Description

Participants who were negative for anti-romosozumab binding antibodies at baseline with a positive result at any time post-baseline.

Time Frame

Day 29, and end of study (day 57 for participants assigned to 1 or 3 mg/kg romosozumab/placebo or day 85 for participants assigned to 5 mg/kg romosozumab/placebo)

Title

Serum Calcium Levels

Time Frame

Baseline, days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85

Title

Serum Intact Parathyroid Hormone (iPTH) Levels

Time Frame

Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85

Secondary Outcome Measure Information:

Title

Maximum Percent Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

Time Frame

Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85

Title

Maximum Percent Change From Baseline in Serum C-telopeptide (CTX)

Time Frame

Baseline and days 2, 3, 4, 6, 8, 12, 22, 29, 43, 57, 71, and 85

Title

Percent Change From Baseline in Sclerostin

Time Frame

Baseline and days 12, 29, 43, 57, 71, and 85

Title

Time to Maximum Observed Concentration of Romosozumab

Description

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Time Frame

Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.

Title

Maximum Observed Concentration of Romosozumab

Description

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Time Frame

Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.

Title

Area Under the Serum Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Romosozumab

Description

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Time Frame

Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.

Title

Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) for Romosozumab

Description

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Time Frame

Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.

Title

Apparent Clearance (CL/F) of Romosozumab

Description

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Time Frame

Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.

Title

Half-life Associated With Beta (Plateau) Phase of Elimination (T1/2,β) for Romosozumab

Description

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Time Frame

Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.

Title

Half-life Associated With Gamma (Terminal) Phase of Elimination (T1/2,ɣ) for Romosozumab

Description

Serum concentrations of romosozumab were measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) was 50 ng/mL.

Time Frame

Predose, 12 hours postdose, and on days 2, 3, 4, 6, 8, 12, 22, 29, 43, and 57, and days 71 and 85 for participants assigned tp 5 mg/kg romosozumab/placebo.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese Body mass index ≤ 25 kg/m², inclusive at screening Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available) Exclusion Criteria: Osteoporosis, 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 ≤ -2.5 History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis; Diagnosed with any condition that will affect bone metabolism

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women

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