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

NCT06588153 | Recruiting Phase 4

• 1 other identifier: 20210125
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Glucocorticoid-induced Osteoporosis

Keywords

Prolia®; Denosumab

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Lumbar Spine BMD Percentage

  At 12 months

Secondary Outcomes (5)

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

  At 3, 6, 9, and 12 months

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

  At 3, 6, 9, and 12 months

• Change from Baseline in Hip and Femoral Neck BMD Percentage

  At 6 and 12 months

• Change from Baseline in Lumbar Spine BMD Percentage

  At 6 months

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

  Up to 12 months

Study Arms (1)

Prolia®

EXPERIMENTAL

Participants with glucocorticoid-induced osteoporosis (GIOP) will receive Prolia® every 6 months (Q6M).

Drug: Prolia®

Interventions

Prolia® DRUG

Subcutaneous (SC) injection in pre-filled syringe.

Also known as: Denosumab

Prolia®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Absolute neutrophil count ≥ 1 x 10\^9 /L
• Platelet count ≥ 100 x 10\^9 /L
• Hemoglobin \> 9 g/dL (90 g/L).
• Coagulation function:
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (16)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Guangzhou First Peoples Hospital

Guangzhou, Guangdong, 510180, China

RECRUITING

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Shenzhen Peoples Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

The First Peoples Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

RECRUITING

Huaian First Peoples Hospital

Huaian, Jiangsu, 223300, China

RECRUITING

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Pingxiang Peoples Hospital

Pingxiang, Jiangxi, 337055, China

RECRUITING

The First Bethune Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

The First Affiliated Hospital of Xi An Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai Municipality, 200052, China

RECRUITING

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030000, China

RECRUITING

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

Sichuan Provincial Peoples Hospital

Chengdu, 610072, China

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: May 24, 2025
• Primary Completion (Estimated): May 24, 2027
• Study Completion (Estimated): May 24, 2027
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

CN (16)