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

NCT01101061 | Completed Phase 1 Results

• 1 other identifier: 20090378
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteopenia

Keywords

Amgen; Phase 1; Postmenopausal; Japanese

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

• 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.

  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)

• Serum Calcium Levels

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

• Serum Intact Parathyroid Hormone (iPTH) Levels

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

Secondary Outcomes (10)

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

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

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

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

• Percent Change From Baseline in Sclerostin

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

• Time to Maximum Observed Concentration of Romosozumab

  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.

• Maximum Observed Concentration of Romosozumab

  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.

Study Arms (2)

Romosozumab

EXPERIMENTAL

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.

Drug: Romosozumab

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo.

Drug: Placebo

Interventions

Romosozumab DRUG

Administered by subcutaneous injection

Also known as: AMG 785, EVENITY™

Romosozumab

Placebo DRUG

Administered by subcutaneous injection

Placebo

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 9, 2010
• Study Start: May 3, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 31, 2019
• Results First Posted: July 31, 2019

Record last verified: 2019-07