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

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Placebo; Drug: Romosozumab

• Registration Number: NCT02791516
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-06
• Study Start: 2017-01-16
• Primary Completion: 2018-02-12
• Disposition First Submitted: 2018-12-03
• Disposition First Submitted QC: 2018-12-03
• Disposition First Posted: 2018-12-05
• Study Completion: 2018-12-21
• Results First Submitted: 2019-04-10
• Results First Submitted QC: 2019-04-10
• Results First Posted: 2019-07-05
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants received placebo subcutaneous injection once a month for 6 months.
Romosozumab	Romosozumab	Participants received 210 mg romosozumab by subcutaneous injection once a month for 6 months.

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Lumbar Spine	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

Name	Time	Method
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Total Hip	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.
Percent Change From Baseline to Month 6 in Bone Mineral Density at the Femoral Neck	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.

Trial Locations

Locations (1)

Research Site; 🇰🇷 Suwon-si, Gyeonggi-do, Korea, Republic of