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

Primary Purpose

Postmenopausal Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Romosozumab
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring Osteoporosis., Osteoporosis-Postmenopausal., Bone Diseases-Metabolic., Bone Diseases., Musculoskeletal Diseases.

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Romosozumab

Arm Description

Participants received placebo subcutaneous injection once a month for 6 months.

Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2016
Last Updated
September 23, 2019
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT02791516
Brief Title
A Safety and Efficacy Study to Evaluate Romosozumab (AMG 785) in South Korean Women With Osteoporosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
February 12, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis
Keywords
Osteoporosis., Osteoporosis-Postmenopausal., Bone Diseases-Metabolic., Bone Diseases., Musculoskeletal Diseases.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo subcutaneous injection once a month for 6 months.
Arm Title
Romosozumab
Arm Type
Experimental
Arm Description
Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.
Intervention Type
Drug
Intervention Name(s)
Romosozumab
Other Intervention Name(s)
AMG 785, Evenity
Intervention Description
Administered by subcutaneous injection once a month (QM)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered by subcutaneous injections once a month
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine
Description
Bone mineral density (BMD) at the lumbar spine was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Time Frame
Baseline and month 6
Secondary Outcome Measure Information:
Title
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip
Description
Bone mineral density (BMD) at the total hip was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Time Frame
Baseline and month 6
Title
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck
Description
Bone mineral density (BMD) at the femoral neck was assessed by dual-energy x-ray absorptiometry (DXA). Images were assessed by a central reader.
Time Frame
Baseline and month 6

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Research Site
City
Gwangju
ZIP/Postal Code
501-757
Country
Korea, Republic of
Facility Name
Research Site
City
Namdong-gu, Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam Si Gyeonggi Do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si, Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33677928
Citation
Baek KH, Chung YS, Koh JM, Kim IJ, Kim KM, Min YK, Park KD, Dinavahi R, Maddox J, Yang W, Kim S, Lee SJ, Cho H, Lim SK. Romosozumab in Postmenopausal Korean Women with Osteoporosis: A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study. Endocrinol Metab (Seoul). 2021 Feb;36(1):60-69. doi: 10.3803/EnM.2020.848. Epub 2021 Feb 24.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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