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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02791516
Recruitment Status : Completed
First Posted : June 6, 2016
Results First Posted : July 5, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Postmenopausal Osteoporosis Drug: Romosozumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : February 12, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791516


Locations
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Korea, Republic of
Research Site
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, 120-752
Research Site
Seoul, Korea, Republic of, 135-710
Research Site
Seoul, Korea, Republic of, 136-705
Research Site
Seoul, Korea, Republic of, 138-736
Research Site
Seoul, Korea, Republic of, 150-713
Research Site
Suwon-si, Gyeonggi-do, Korea, Republic of, 443-380
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] November 13, 2017
Statistical Analysis Plan  [PDF] March 9, 2018

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02791516    
Other Study ID Numbers: 20150242
First Posted: June 6, 2016    Key Record Dates
Results First Posted: July 5, 2019
Last Update Posted: October 7, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Osteoporosis.
Osteoporosis-Postmenopausal.
Bone Diseases-Metabolic.
Bone Diseases.
Musculoskeletal Diseases.
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases