NCT05397938

Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis

A Randomized, Double-blind, Double-dummy, Positive-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 231 (estimated)
• Sponsor: Shanghai JMT-Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glucocorticoid Induced Osteoporosis

Interventions

Type	Name	Description
DRUG	JMT103	JMT103, subcutaneous injection, once every 6 months (Q6M)
DRUG	Alendronate sodium	Alendronate sodium tablet, once every week (QW)
DRUG	JMT103 placebo	JMT103 placebo, subcutaneous injection, once every 6 months (Q6M)
DRUG	Alendronate sodium placebo	Alendronate sodium tablet placebo, once every week (QW)

Timeline

• Start date: 2022-06-15
• Primary completion: 2022-07-01
• Completion: 2023-06-01
• First posted: 2022-05-31
• Last updated: 2022-05-31

Locations

1 site across 1 country: China