A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis

September 23, 2019 updated by: Amgen

A Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Postmenopausal South Korean Women With Osteoporosis

The primary objective is to evaluate the effect of treatment with romosozumab for 6 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual-energy X-ray absorptiometry (DXA) in postmenopausal women with osteoporosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-739
        • Research Site
      • Gwangju, Korea, Republic of, 501-757
        • Research Site
      • Namdong-gu, Incheon, Korea, Republic of, 21565
        • Research Site
      • Seongnam Si Gyeonggi Do, Korea, Republic of, 463-707
        • Research Site
      • Seoul, Korea, Republic of, 135-710
        • Research Site
      • Seoul, Korea, Republic of, 150-713
        • Research Site
      • Seoul, Korea, Republic of, 120-752
        • Research Site
      • Seoul, Korea, Republic of, 138-736
        • Research Site
      • Seoul, Korea, Republic of, 136-705
        • Research Site
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 443-380
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ambulatory postmenopausal Korean women, ≥ 55 to ≤ 90 years of age at enrollment.
  • Postmenopause is defined as no spontaneous vaginal bleeding or spotting for 12 or more consecutive months prior to screening.
  • BMD T-score </= -2.50 at the lumbar spine, total hip or femoral neck.
  • At least 2 vertebrae in the L1 through L4 region and at least one hip are evaluable by DXA.
  • Other inclusion criteria may apply.

Exclusion Criteria:

  • Subjects with a BMD T-score </= -4.0 at the lumbar spine, total hip, or femoral neck.
  • History of hip fracture.
  • Bone disease other than osteoporosis/ or evidence of any other clinically significant disorder, condition/ or disease or significant laboratory abnormalities.
  • Known sensitivity or intolerance calcium and vitamin D products.
  • Other exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants received placebo subcutaneous injection once a month for 6 months.
Drug: Placebo
Administered by subcutaneous injections once a month
Experimental: Romosozumab
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
Drug: Romosozumab
Administered by subcutaneous injection once a month (QM)
Other Names:
  • AMG 785
  • Evenity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
Time Frame: Baseline and month 6
Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Baseline and month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip
Time Frame: Baseline and month 6
Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Baseline and month 6
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck
Time Frame: Baseline and month 6
Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Baseline and month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2017

Primary Completion (Actual)

February 12, 2018

Study Completion (Actual)

December 21, 2018

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 2, 2016

First Posted (Estimate)

June 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 7, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150242

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postmenopausal Osteoporosis

Clinical Trials on Romosozumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe