Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05397938
Status:
UNKNOWN
Last Update Posted:
2022-05-31
First Post:
2022-05-25
Brief Title:
Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis
Sponsor:
Shanghai JMT-Bio Inc
Organization:
Shanghai JMT-Bio Inc
Study Overview
Official Title:
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
Status Verified Date:
2021-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None