The primary objective of this study is to evaluate the efficacy of Prolia on lumbar spine BMD at 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Partcipants will receive subcutaneous (SC) injections of Prolia Q6M.
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Percent change from baseline in bone mineral density (BMD) of lumbar spine at month 12
Time frame: Baseline and Month 12
Percent change from baseline in serum C-terminal telopeptide (CTx) at month 3, 6, 9, and 12
Time frame: Baseline and Months 3, 6, 9, and 12
Percent change from baseline in serum procollagen Type 1 N-Telopeptide (P1NP) at month 3, 6, 9, and 12
Time frame: Baseline and Months 3, 6, 9, and 12
Percent change from baseline in total hip and femoral neck BMD at month 6 and 12
Time frame: Baseline and Months 6 and 12
Percent change from baseline in lumbar spine BMD at month 6
Time frame: Baseline and Month 6
Number of participants with adverse events (AE)
Time frame: Up to 12 Months
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