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Clinical Trials in China / NCT06332014
Active, not recruiting Phase 4

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

NCT06332014 · tracked via the Priya Life Science China tracker
Sponsor
Amgen
Phase
Phase 4
Started
2024-08-06
Last updated
2026-02-12

Condition(s) studied

Osteoporosis

Investigational drug(s) / intervention(s)

Prolia

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

Study summary

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

Eligibility

Sex
MALE
Min age
30 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality
Beijing Jishuitan Hospital Beijing Beijing Municipality
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Sun Yat-sen Memorial Hospital Sun Yat-sen University Guangzhou Guangdong
Nanfang Hospital Southern Medical University Guangzhou Guangdong
The Fourth Hospital of Harbin Medical University Harbin Heilongjiang
Huaian First Peoples Hospital Huaian Jiangsu
The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
The First Peoples Hospital of Kunshan Suzhou Jiangsu
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
Xuzhou Central Hospital Xuzhou Jiangsu
Jiangxi Provincial Peoples Hospital Nanchang Jiangxi
Pingxiang Peoples Hospital Pingxiang Jiangxi
Qilu Hospital of Shandong University Jinan Shandong
Shanghai Sixth Peoples Hospital Shanghai China

More Amgen trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06332014 on ClinicalTrials.gov ↗ ← All trials in China