Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis
Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, double-dummy, positive-controlled phase II interventional
study designed to evaluate the efficacy and safety of JMT103 in the treatment of
glucocorticoid induced osteoporosis patients. Patients will be enrolled and randomized to 3
treatment groups, JMT103 60 mg group (and alendronate sodium tablet placebo), JMT103 90 mg
group (and alendronate sodium tablet placebo), and alendronate sodium 70 mg active comparator
group (and JMT103 placebo). The primary outcome measure is percent change from baseline in
lumbar bone mineral density (BMD) at 12 months of treatment. Besides, percent change of
lumbar BMD at 6 months, percent change of total hip and femoral neck BMD at 12 months, and
the incidence of new fracture at 12 months will be evaluated. Biomarkers of s-CTX and PINP,
PK evaluation of JMT103 serum drug concentration, immunogenicity evaluation of ADA and Nab,
and adverse events will be also collected.