Evaluating Prolia for Male Osteoporosis in China

A Phase 4 Single Arm Open Label Study for the Efficacy and Safety of Prolia in Treatment of Male Subjects With Osteoporosis in Mainland China

This study is testing if Prolia can help improve bone strength in Chinese men with osteoporosis over a year.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 30 Years to 90 Years
• Sex: Male
• Sponsor: Amgen (Industry-sponsored)
• Drugs / interventions: denosumab, prednisone
• Locations: 10 sites (Beijing, Beijing and 9 other locations)
• Trial ID: NCT06332014 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of Prolia (Denosumab) in improving bone mineral density (BMD) in the lumbar spine of ambulatory Chinese men diagnosed with osteoporosis. Participants will be men aged 30 to 90 years with specific BMD criteria, including a T-score of -2.5 or lower, or -1.5 with a history of fragility fractures. The study will monitor changes in BMD over a 12-month period to determine the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are ambulatory Chinese men aged 30 to 90 with osteoporosis as indicated by specific BMD T-scores.

Not a fit: Patients with conditions affecting bone metabolism or those with a history of certain cancers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for men suffering from osteoporosis, potentially reducing fracture risk and improving quality of life.

How similar studies have performed: Previous studies have shown positive outcomes with Prolia in treating osteoporosis, indicating that this approach is supported by existing evidence.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 9 other locations

• Peking University First Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Jishuitan Hospital — Beijing, Beijing, China (Recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Recruiting)
• Sun Yat-sen Memorial Hospital Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• Jiangxi Provincial Peoples Hospital — Nanchang, Jiangxi, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Shanghai Sixth Peoples Hospital — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Amgen Call Center

Conditions Osteoporosis; Prolia; Denosumab; AMG 162