Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China
- Registration Number
- NCT06332014
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prolia Prolia Participants will receive Prolia every six months (Q6M)
- Primary Outcome Measures
Name Time Method Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12 Baseline and Month 12
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AE) Up to 12 Months 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 lumbar spine BMD at month 6 Baseline and Month 6 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
Trial Locations
- Locations (10)
Shanghai Sixth Peoples Hospital
🇨🇳Shanghai, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Beijing Jishuitan Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Sun Yat-sen Memorial Hospital Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Jiangxi Provincial Peoples Hospital
🇨🇳Nanchang, Jiangxi, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China