A Phase 4 Single-arm Open-label Study for the Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participant has provided informed consent prior to initiation of any study-specific activities/procedures.

• Male and female participants aged ≥ 18 years at the time of signing the informed consent.

• Participants are receiving glucocorticoid treatment at screening.

• Participants who are ≥ 50 years of age at the time of screening will be required to have a T-score with:

• \- a BMD value equivalent to a T-score ≤ -2.5 at the lumbar spine or total hip or femoral neck; OR

• \- a BMD value equivalent to a T-score ≤ -1.0 at the lumbar spine or total hip or femoral neck AND a history of osteoporotic fracture.

• Participants who are \< 50 years of age at the time of screening will be required to have a T-score with a BMD value equivalent to a T-score ≤ -1.0 at the lumbar spine or total hip or femoral neck AND have a history of osteoporotic fracture.

• At least 2 lumbar vertebrae from L1 through L4 and 1 hip must be evaluable by dual-energy x-ray absorptiometry (DXA).

• Adequate organ function, defined as follows:

‣ Hematological function:

• Absolute neutrophil count ≥ 1 x 10\^9 /L

∙ Platelet count ≥ 100 x 10\^9 /L

∙ Hemoglobin \> 9 g/dL (90 g/L).

⁃ Coagulation function:

‣ 1 Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN). Participants on chronic anticoagulation therapy who do not meet the criteria above may be eligible to enroll at the investigator's discretion per local standard of care.

⁃ Renal function:

‣ 1 Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation \> 30 mL/min/1.73 m\^2.

⁃ Hepatic function:

• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \< 3 x ULN

∙ Total bilirubin (TBL) \< 1.5 x ULN.

Locations
Other Locations
China
Beijing Friendship Hospital Capital Medical University
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
The First Peoples Hospital of Changzhou
RECRUITING
Changzhou
Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
Guangzhou First Peoples Hospital
RECRUITING
Guangzhou
Zhejiang Provincial Peoples Hospital
RECRUITING
Hangzhou
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
RECRUITING
Shanghai
Shenzhen Peoples Hospital
RECRUITING
Shenzhen
First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
The First Affiliated Hospital of Xi An Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2025-05-24
Estimated Completion Date: 2027-05-24
Participants
Target number of participants: 100
Treatments
Experimental: Prolia®
Participants with glucocorticoid-induced osteoporosis (GIOP) will receive Prolia® every 6 months (Q6M).
Related Therapeutic Areas
Sponsors
Leads: Amgen

This content was sourced from clinicaltrials.gov