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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China

A Phase 4 Single-arm Open-label Study for the Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China

A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China (NCT06588153) is a Phase 4 interventional studying Glucocorticoid-induced Osteoporosis, sponsored by Amgen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Glucocorticoid-induced Osteoporosis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Criteria - Participant has provided willing to sign a consent form prior to initiation of any study-specific activities/procedures. - Male and female participants aged ≥ 18 years at the time of signing the willing to sign a consent form. - 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). - your organs (liver, kidneys, etc.) are working well enough based on blood tests, 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria * Participant has provided informed consent prior to initiation of any study-specific activities/procedures. * 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 Disease Related * 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.

Treatments Being Tested

DRUG

Prolia®

Subcutaneous (SC) injection in pre-filled syringe.

Locations (16)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Guangzhou First Peoples Hospital
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Peoples Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China
Huaian First Peoples Hospital
Huaian, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, 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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06588153), the sponsor (Amgen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06588153 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06588153?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06588153?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06588153. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06588153. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.