A Phase 4 Single Arm Open Label Study for the Efficacy and Safety of Prolia in Treatment of Male Subjects With Osteoporosis in Mainland China
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 30
Maximum Age: 90
Healthy Volunteers: f
View:
• Ambulatory Chinese men aged ≥ 30 years and ≤ 90 years old at the time of signing the informed consent.
• Men at the time of screening will be required to have lumbar spine or total hip BMD T-score ≤ -2.5 or T-score ≤ -1.5 and a history of a fragility fracture.
• Have to have at least two intact vertebrae at baseline (L1-L4).
Locations
Other Locations
China
Beijing Jishuitan Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Nanfang Hospital Southern Medical University
RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital Sun Yat-sen University
RECRUITING
Guangzhou
The Fourth Hospital of Harbin Medical University
RECRUITING
Harbin
Huaian First Peoples Hospital
RECRUITING
Huaian
Qilu Hospital of Shandong University
RECRUITING
Jinan
Jiangxi Provincial Peoples Hospital
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Pingxiang Peoples Hospital
RECRUITING
Pingxiang
Shanghai Sixth Peoples Hospital
RECRUITING
Shanghai
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The First Peoples Hospital of Kunshan
RECRUITING
Suzhou
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Xuzhou Central Hospital
RECRUITING
Xuzhou
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2024-08-06
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 100
Treatments
Experimental: Prolia
Participants will receive Prolia every six months (Q6M)
Related Therapeutic Areas
Sponsors
Leads: Amgen