Actively Recruiting
A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China
Led by Amgen · Updated on 2026-03-25
100
Participants Needed
16
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective of this study is to evaluate the efficacy of Prolia® in improving bone mass density (BMD) of lumbar spine at month 12.
CONDITIONS
Official Title
A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before starting any study activities
- Male or female aged 18 years or older at consent
- Receiving glucocorticoid treatment at screening
- If 50 years or older, must have a T-score ≤ -2.5 at lumbar spine, total hip, or femoral neck; OR a T-score ≤ -1.0 at these sites plus history of osteoporotic fracture
- If under 50 years, must have a T-score ≤ -1.0 at lumbar spine, total hip, or femoral neck plus history of osteoporotic fracture
- At least 2 lumbar vertebrae (L1-L4) and 1 hip evaluable by DXA scan
- Adequate organ function: neutrophil count ≥ 1 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin > 9 g/dL; coagulation times ≤ 1.5 times upper limit of normal unless on chronic anticoagulation per investigator discretion; estimated glomerular filtration rate > 30 mL/min/1.73 m^2; liver enzymes AST, ALT, alkaline phosphatase < 3 times upper limit of normal; total bilirubin < 1.5 times upper limit of normal
You will not qualify if you...
- Prior use of bisphosphonates within 1 year (except oral use < 3 months before screening) or intravenous zoledronate within 2 years
- Use of osteoporosis treatments including fluoride, strontium, anabolic agents (PTH or derivatives), denosumab
- Use of selective estrogen receptor modulators, tibolone, anabolic steroids, non-stable hormone therapies, or calcitonin within 3 months
- Use of other bone-active drugs like anti-convulsants (except benzodiazepines), heparin (except low molecular weight), systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum, lithium, protease inhibitors, or gonadotropin-releasing hormone agonists
- Use of anti-inflammatory DMARDs not consistent with local guidelines
- Active or recent serious infections within specified time frames
- History of thyroid disorders (unless stable), hypo/hyperparathyroidism, Addison's disease, osteomalacia, osteonecrosis of the jaw, recent dental surgery or planned invasive dental work
- History of Paget's disease or other bone diseases affecting metabolism
- Prior organ or bone marrow transplant
- Positive for HIV, hepatitis B or C
- History of any cancer except cured basal or squamous cell cancers
- Participation in other investigational studies within 30 days or 5 half-lives
- Vitamin D deficiency, hypercalcemia, elevated liver enzymes, or abnormal calcium levels
- Female participants of childbearing potential unwilling to use contraception or who are breastfeeding or pregnant
- Known sensitivity to study drug or components
- Unlikely to complete study visits or follow procedures
- Any other clinically significant disorder posing safety risk or interfering with study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
2
Guangzhou First Peoples Hospital
Guangzhou, Guangdong, China, 510180
Actively Recruiting
3
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
4
Shenzhen Peoples Hospital
Shenzhen, Guangdong, China, 518020
Actively Recruiting
5
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471003
Actively Recruiting
6
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
7
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China, 213003
Actively Recruiting
8
Huaian First Peoples Hospital
Huaian, Jiangsu, China, 223300
Actively Recruiting
9
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
10
Pingxiang Peoples Hospital
Pingxiang, Jiangxi, China, 337055
Actively Recruiting
11
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
12
The First Affiliated Hospital of Xi An Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
13
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, China, 200052
Actively Recruiting
14
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030000
Actively Recruiting
15
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
16
Sichuan Provincial Peoples Hospital
Chengdu, China, 610072
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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