AzTrials
AzTrials

Glucocorticoid-induced OsteoporosisPhase 4NCT06588153

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

A Phase 4 study testing Prolia® in people with Glucocorticoid-induced Osteoporosis, run by Amgen at 16 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glucocorticoid-induced Osteoporosis
What is being tested?
Prolia®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
16 sitesChina
Study dates
24 May 2025to 27 Apr 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 20Show fewer
  • 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:
  • Absolute neutrophil count ≥ 1 x 10^9 /L
  • Platelet count ≥ 100 x 10^9 /L
  • 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:
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase < 3 x ULN
  • Total bilirubin (TBL) < 1.5 x ULN.

Who cannot join

  • Disease Related
  • Received other osteoporosis treatment or bone-active treatment with:
  • prior use of bisphosphonate:
  • bisphosphonate use within 1 year unless duration of oral bisphosphonates treatment < 3 months use prior to screening
  • 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
Show all 54Show fewer
  • 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.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

China16 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu, 213003

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072

  • Guangzhou First Peoples Hospital

    Guangzhou, Guangdong, 510180

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510515

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang, 310014

  • Huaian First Peoples Hospital

    Huaian, Jiangsu, 223300

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

  • Pingxiang Peoples Hospital

    Pingxiang, Jiangxi, 337055

  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

    Shanghai, Shanghai Municipality, 200052

  • Shenzhen Peoples Hospital

    Shenzhen, Guangdong, 518020

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Xi An Jiaotong University

    Xi'an, Shaanxi, 710061

Other trials in China

About this study

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

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.

Being tested
Prolia®
Keywords
Prolia®, Denosumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolia®Drug

    Also called Denosumab

    Subcutaneous (SC) injection in pre-filled syringe.

Study groups in NCT06588153
Study groupRoleWhat they receive
Prolia®ExperimentalParticipants with glucocorticoid-induced osteoporosis (GIOP) will receive Prolia® every 6 months (Q6M).
Receives: Drug: Prolia®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Lumbar Spine BMD Percentage

    Measured: At 12 months

Secondary outcomes (5)

  1. Change from Baseline in C-terminal Telopeptide (CTx) Expression

    Measured: At 3, 6, 9, and 12 months

  2. Change from Baseline in Procollagen Type 1 N-Telopeptide (P1NP) Expression

    Measured: At 3, 6, 9, and 12 months

  3. Change from Baseline in Hip and Femoral Neck BMD Percentage

    Measured: At 6 and 12 months

  4. Change from Baseline in Lumbar Spine BMD Percentage

    Measured: At 6 months

  5. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a treatment, combination product, medical device, or procedure. TEAEs are any event that occurred after the participant received study treatment. Serious AEs (SAEs) are defined as any untoward medical occurrence that, meets at least 1 of the following serious criteria: immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start24 May 2025
  3. Primary completion27 Apr 2027 (estimated)
  4. Study completion27 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588153
Sponsor's protocol ID
20210125
Status last verified
May 2026
First submitted
5 Sep 2024
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prolia® in people with Glucocorticoid-induced Osteoporosis, run by Amgen at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Lumbar Spine BMD Percentage (time frame: At 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06588153.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in