NCT02791516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

January 16, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
7 months until next milestone

Results Posted

Study results publicly available

July 5, 2019

Completed
Last Updated

October 7, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

June 2, 2016

Results QC Date

April 10, 2019

Last Update Submit

September 23, 2019

Conditions

Postmenopausal Osteoporosis

Keywords

Osteoporosis.Osteoporosis-Postmenopausal.Bone Diseases-Metabolic.Bone Diseases.Musculoskeletal Diseases.

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and month 6

Secondary Outcomes (2)

  • Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip

    Baseline and month 6

  • Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck

    Baseline and month 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Romosozumab

EXPERIMENTAL

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

Drug: Romosozumab

Interventions

RomosozumabDRUG

Administered by subcutaneous injection once a month (QM)

Also known as: AMG 785, Evenity
Romosozumab
PlaceboDRUG

Administered by subcutaneous injections once a month

Placebo

Eligibility Criteria

Age55 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research Site

Busan, 602-739, South Korea

Location

Research Site

Gwangju, 501-757, South Korea

Location

Research Site

Namdong-gu, Incheon, 21565, South Korea

Location

Research Site

Seongnam Si Gyeonggi Do, 463-707, South Korea

Location

Research Site

Seoul, 120-752, South Korea

Location

Research Site

Seoul, 135-710, South Korea

Location

Research Site

Seoul, 136-705, South Korea

Location

Research Site

Seoul, 138-736, South Korea

Location

Research Site

Seoul, 150-713, South Korea

Location

Research Site

Suwon-si, Gyeonggi-do, 443-380, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33677928DERIVED

Related Links

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal Diseases

Interventions

romosozumab

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional 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 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2016

First Posted

June 6, 2016

Study Start

January 16, 2017

Primary Completion

February 12, 2018

Study Completion

December 21, 2018

Last Updated

October 7, 2019

Results First Posted

July 5, 2019

Record last verified: 2019-09

Locations

KR(10)