A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China
NCT ID: NCT06588153
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2025-05-24
2027-05-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prolia®
Participants with glucocorticoid-induced osteoporosis (GIOP) will receive Prolia® every 6 months (Q6M).
Prolia®
Subcutaneous (SC) injection in pre-filled syringe.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prolia®
Subcutaneous (SC) injection in pre-filled syringe.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male and female participants aged ≥ 18 years at the time of signing the informed consent.
* Participants are receiving glucocorticoid treatment at screening.
* Participants who are ≥ 50 years of age at the time of screening will be required to have a T-score with:
\- a BMD value equivalent to a T-score ≤ -2.5 at the lumbar spine or total hip or femoral neck; OR
\- a BMD value equivalent to a T-score ≤ -1.0 at the lumbar spine or total hip or femoral neck AND a history of osteoporotic fracture.
* Participants who are \< 50 years of age at the time of screening will be required to have a T-score with a BMD value equivalent to a T-score ≤ -1.0 at the lumbar spine or total hip or femoral neck AND have a history of osteoporotic fracture.
* At least 2 lumbar vertebrae from L1 through L4 and 1 hip must be evaluable by dual-energy x-ray absorptiometry (DXA).
* Adequate organ function, defined as follows:
* Hematological function:
1. Absolute neutrophil count ≥ 1 x 10\^9 /L
2. Platelet count ≥ 100 x 10\^9 /L
3. Hemoglobin \> 9 g/dL (90 g/L).
* Coagulation function:
1 Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN). Participants on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll at the investigator's discretion per local standard of care.
* Renal function:
1 Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation \> 30 mL/min/1.73 m\^2.
* Hepatic function:
1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \< 3 x ULN
2. Total bilirubin (TBL) \< 1.5 x ULN.
Exclusion Criteria
* Received other osteoporosis treatment or bone-active treatment with:
\- prior use of bisphosphonate:
1. bisphosphonate use within 1 year unless duration of oral bisphosphonates treatment \< 3 months use prior to screening
2. administration of intravenous zoledronate within 2 years or intravenous bisphosphonate other than zoledronate within the last year.
* fluoride or strontium for osteoporosis within the last 5 years
* anabolic agents to include PTH or PTH derivatives within the last year
* any prior use of products containing denosumab
* Administration of any of the following treatments within 3 months of screening:
\- any selective estrogen receptor modulator (estrogen agonist antagonist)
* tibolone
* anabolic steroids
* testosterone above normal replacement doses not on stable dose
* systemic hormone replacement therapy not on stable dose
* systemic hormonal contraception not specified in the protocol or not on stable dose
* calcitonin.
* Other bone-active drugs including:
* anti-convulsants (except benzodiazepines) and heparin (low molecular weight heparin is allowed)
* chronic systemic ketoconazole, androgens, adrenocorticotropic hormone (ACTH), cinacalcet, aluminum, lithium, protease inhibitors, gonadotropin-releasing hormone agonists.
* Any pretrial initiation of anti-inflammatory disease-modifying anti-rheumatic drug (DMARD) that is not consistent with the local Chinese label or guidelines.
* Participant has an active infection or history of infections as follows:
* any active infection for which systemic anti-infectives were used within 4 weeks prior to screening
* a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening
* recurrent or chronic infections or other active infection that, in the opinion of the investigator, might compromise the safety of the participant.
Other Medical Conditions
* History of hyperthyroidism (stable on antithyroid therapy is allowed) when suggested by medical history
* History of hypothyroidism (stable on thyroid replacement therapy is allowed) when suggested by medical history
* History of hypo- or hyperparathyroidism
* History of Addison's disease
* History of osteomalacia
* History of osteonecrosis of the jaw (ONJ)
* History of tooth extraction or other dental surgery within the prior 6 months
* Invasive dental work (per local oral surgeon's assessment) planned in the next 12 months
* History of Paget's disease of bone
* Other bone diseases which affect bone metabolism (e.g., osteopetrosis, osteogenesis imperfecta) (chart review)
* Received any solid organ or bone marrow transplant
* Known to have tested positive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen
* Participants with a history of any cancer (cured basal cell or squamous cell cancers are allowed)
Prior/Concurrent Clinical Study Experience • Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives, whichever is longer, since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
Diagnostic Assessments
* Abnormalities of the following per central laboratory reference ranges:
\- Vitamin D deficiency (25\[OH\] vitamin D level \< 20 ng/mL \[\< 49.9 nmol/L\]). Vitamin D replenishment will be permitted, and participants may be re-screened once.
\- Hypercalcemia.
\- Elevated transaminases ≥ 3.0 x ULN.
* Elevated TBL \> 1.5 x ULN.
* Albumin-adjusted serum calcium levels \< 8.5 mg/dL or \> 10.5 mg/dL.
Other Exclusions
* Female participants of childbearing potential unwilling to use protocol-specified method of contraception (see Appendix 5, Section 11.5) during treatment and for an additional 5 months after the last dose of Prolia®.
* Female participants who are breastfeeding or who plan to breastfeed while on study through 5 months after the last dose of Prolia®.
* Female participants planning to become pregnant while on study through 5 months after the last dose of Prolia®.
* Female participants of childbearing potential with a positive pregnancy test assessed at Screening by a serum pregnancy test.
* Participant has known sensitivity to any of the products or components to be administered during dosing.
* Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant's and investigator's knowledge.
* History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Friendship Hospital Capital Medical University
Beijing, Beijing Municipality, China
Guangzhou First Peoples Hospital
Guangzhou, Guangdong, China
Shenzhen Peoples Hospital
Shenzhen, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China
Pingxiang Peoples Hospital
Pingxiang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Xi An Jiaotong University
Xi'an, Shaanxi, China
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, China
Sichuan Provincial Peoples Hospital
Chengdu, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20210125
Identifier Type: -
Identifier Source: org_study_id