Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China
NCT ID: NCT06332014
Last Updated: 2025-10-15
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
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RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2024-08-06
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prolia
Participants will receive Prolia every six months (Q6M)
Prolia
Partcipants will receive subcutaneous (SC) injections of Prolia Q6M.
Interventions
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Prolia
Partcipants will receive subcutaneous (SC) injections of Prolia Q6M.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
30 Years
90 Years
MALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Huaian First Peoples Hospital
Huaian, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Peoples Hospital of Kunshan
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jiangxi Provincial Peoples Hospital
Nanchang, Jiangxi, China
Pingxiang Peoples Hospital
Pingxiang, Jiangxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai Sixth Peoples Hospital
Shanghai, , China
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20210123
Identifier Type: -
Identifier Source: org_study_id
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