Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China
NCT06332014 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2026-02-12
Summary
The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.
Conditions
Interventions
- DRUG
-
Prolia
Partcipants will receive subcutaneous (SC) injections of Prolia Q6M.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 30 Years
- Max Age
- 90 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-06
- Primary Completion
- 2027-01-23
- Completion
- 2027-01-23
Countries
- China
Study Locations
More Related Trials
-
Denosumab China Phase III Study
NCT02014467 ·Status: COMPLETED ·Phase: PHASE3
-
A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis
NCT06804590 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Test the Efficacy, Safety and Tolerability of Romosozumab Treatment in Postmenopausal Chinese Women With Osteoporosis
NCT05067335 ·Status: COMPLETED ·Phase: PHASE3
-
Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis
NCT02732210 ·Status: COMPLETED
-
A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
NCT05060406 ·Status: UNKNOWN ·Phase: PHASE3
-
Preventing Osteoporosis Using Denosumab
NCT02753283 ·Status: COMPLETED ·Phase: PHASE4
-
A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
NCT07062978 ·Status: RECRUITING ·Phase: PHASE3
-
Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes
NCT06154707 ·Status: RECRUITING ·Phase: PHASE3
-
Intervention Study of Drugs in Patients Osteopenia and Osteoporosis
NCT04719572 ·Status: UNKNOWN ·Phase: NA
-
Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects
NCT06037395 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk
NCT04128163 ·Status: UNKNOWN ·Phase: PHASE3
-
Denosumab and Osteoporotic Vertebral Compression Fracture
NCT05058443 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Clinical Efficacy and Safety Comparative Study Between CMAB807 Injection and Prolia® .
NCT04591275 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women
NCT00860964 ·Status: COMPLETED ·Phase: PHASE4
-
China HVT Safety, PK, PD
NCT02135640 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis
NCT00980174 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of JMT103 in the Treatment of Postmenopausal Women With Osteoporosis
NCT05278338 ·Status: UNKNOWN ·Phase: PHASE2
-
A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects
NCT00306189 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy Adults
NCT04213105 ·Status: UNKNOWN ·Phase: PHASE1
-
Phase 1 Study to Compare CMAB807 Injection to Prolia® in Healthy Volunteers
NCT03925051 ·Status: COMPLETED ·Phase: PHASE1
-
Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults
NCT04940845 ·Status: UNKNOWN ·Phase: PHASE1
-
TST002 Intervenous Injection in Postmenopausal Women and Men With Reduced Bone Mineral Density
NCT05391776 ·Status: UNKNOWN ·Phase: PHASE1
-
A Study to Evaluate the Denosumab in Healthy Adults
NCT03427853 ·Status: UNKNOWN ·Phase: PHASE1
-
The Effect Of Oral Ibandronate In Male Osteoporosis
NCT00397839 ·Status: COMPLETED ·Phase: PHASE3
-
Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
NCT01652690 ·Status: COMPLETED