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

Postmenopausal Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791516
• Other study ID #: 20150242
• Status: Completed
• Phase: Phase 3
• Start date: January 16, 2017
• Est. completion date: December 21, 2018

Study information

• Verified date: September 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 21, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Romosozumab
Administered by subcutaneous injection once a month (QM)
• Placebo
Administered by subcutaneous injections once a month

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Namdong-gu, Incheon
Korea, Republic of	Research Site	Seongnam Si Gyeonggi Do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si, Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline and month 6
Secondary	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.	Baseline and month 6

External Links

•   AmgenTrials clinical trials website