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