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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06332014
• Other study ID #: 20210123
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 31, 2024
• Est. completion date: July 29, 2026

Study information

• Verified date: March 2024
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 29, 2026
• Est. primary completion date: July 29, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• Ambulatory 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.
• 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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12		Baseline and Month 12
Secondary	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
Secondary	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
Secondary	Percent change from baseline in total hip and femoral neck BMD at month 6 and 12		Baseline and Months 6 and 12
Secondary	Percent change from baseline in lumbar spine BMD at month 6		Baseline and Month 6
Secondary	Number of participants with adverse events (AE)		Up to 12 Months

External Links

•   AmgenTrials clinical trials website