A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China

Phase 4

Recruiting

• Conditions: Glucocorticoid-induced Osteoporosis
• Interventions: Drug: Prolia®

• Registration Number: NCT06588153
• Lead Sponsor: Amgen

Brief Summary

The main objective of this study is to evaluate the efficacy of Prolia® in improving bone mass density (BMD) of lumbar spine at month 12.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-19
• Study Start: 2025-05-24
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Primary Completion: 2027-05-24
• Study Completion: 2027-05-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prolia®	Prolia®	Participants with glucocorticoid-induced osteoporosis (GIOP) will receive Prolia® every 6 months (Q6M).

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Lumbar Spine BMD Percentage	At 12 months

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in C-terminal Telopeptide (CTx) Expression	At 3, 6, 9, and 12 months
Change from Baseline in Procollagen Type 1 N-Telopeptide (P1NP) Expression	At 3, 6, 9, and 12 months
Change from Baseline in Hip and Femoral Neck BMD Percentage	At 6 and 12 months
Change from Baseline in Lumbar Spine BMD Percentage	At 6 months
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Up to 12 months	An adverse event (AE) is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a treatment, combination product, medical device, or procedure. TEAEs are any event that occurred after the participant received study treatment. Serious AEs (SAEs) are defined as any untoward medical occurrence that, meets at least 1 of the following serious criteria: immediately life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect.

Trial Locations

Locations (1)

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine; 🇨🇳 Pudong, Shanghai, China

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

🇨🇳Pudong, Shanghai, China