Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China

NCT06332014 | Active Not Recruiting Phase 4

• 1 other identifier: 20210123
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 16

Brief Summary

The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.

Conditions

Osteoporosis

Keywords

Prolia; Denosumab; AMG 162; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12

  Baseline and Month 12

Secondary Outcomes (5)

• Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12

  Baseline and Months 3, 6, 9, and 12

• Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12

  Baseline and Months 3, 6, 9, and 12

• Percent change from baseline in total hip and femoral neck BMD at month 6 and 12

  Baseline and Months 6 and 12

• Percent change from baseline in lumbar spine BMD at month 6

  Baseline and Month 6

• Number of participants with adverse events (AE)

  Up to 12 Months

Study Arms (1)

Prolia

EXPERIMENTAL

Participants will receive Prolia every six months (Q6M)

Drug: Prolia

Interventions

Prolia DRUG

Partcipants will receive subcutaneous (SC) injections of Prolia Q6M.

Also known as: Denosumab

Prolia

Eligibility Criteria

• Age: 30 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory Chinese men aged ≥ 30 years and ≤ 90 years old at the time of signing the informed consent.
• Men at the time of screening will be required to have lumbar spine or total hip BMD T-score ≤ -2.5 or T-score ≤ -1.5 and a history of a fragility fracture.
• Have to have at least two intact vertebrae at baseline (L1-L4).

You may not qualify if:

• Any condition that could affect bone metabolism such as Paget's disease of bone, osteomalacia including secondary causes of osteoporosis (subjects with low testosterone levels are allowed).
• Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed.
• Participants with a history of any cancer (cured basal cell or squamous cell cancers are allowed).
• Any condition that in the opinion of the investigator would not allow the subject to complete 1 year study and comply with the requirement of the study protocol.
• Hypogonadism requiring testosterone replacement therapy unless on a stable dose for at least 12 months.
• Administration of intravenous bisphosphonate, or fluoride (except for dental treatment) or strontium ranelate. Systemic glucocorticoids: ≥ 7.5 mg prednisone equivalent per day for more than 14 days within 3 months before randomization. Any bone anabolic treatment within 1 year. Anabolic steroids or testosterone: any use within 6 months before randomization.
• Oral bisphosphonates treatment.
• Known to have tested positive for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or cirrhosis of the liver.
• Received any solid organ or bone marrow transplant or is on chronic immunosuppression for any reason.
• Oral/dental conditions that would require an intervention including tooth extraction during the course of the study and invasive dental work (per local oral surgeon's assessment) planned in the next 12 months.
• Any prior use of products containing denosumab.
• Currently receiving treatment in another investigational device or drug study, or less than 1 month since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
• Vitamin D levels \< 20 ng/mL (subjects are allowed into the study after vitamin D levels are corrected and subjects re-screened).
• Albumin-adjusted serum calcium levels \< 8.5 mg/dl or \> 10.5 mg/dl.

Sponsors & Collaborators

• Amgen: lead

Study Sites (16)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Huaian First Peoples Hospital

Huaian, Jiangsu, 223300, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Peoples Hospital of Kunshan

Suzhou, Jiangsu, 215300, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

Location

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China

Location

Jiangxi Provincial Peoples Hospital

Nanchang, Jiangxi, 330038, China

Location

Pingxiang Peoples Hospital

Pingxiang, Jiangxi, 337000, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Shanghai Sixth Peoples Hospital

Shanghai, 200233, China

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

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

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: March 19, 2024
• First Posted: March 26, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): January 23, 2027
• Study Completion (Estimated): January 23, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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)