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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMT103 60 mg group | Experimental | Patients will be administrated with JMT103 60 mg subcutaneously every 6 months (Q6W) and alendronate sodium tablet placebo once every week (QW). |
|
| JMT103 90 mg group | Experimental | Patients will be administrated with JMT103 90 mg subcutaneously every 6 months (Q6W) and alendronate sodium tablet placebo once every week (QW). |
|
| Alendronate sodium group | Active Comparator | Patients will be administrated with alendronate sodium tablet orally 70 mg weekly (QW) and JMT103 placebo subcutaneously every 6 months (Q6W). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMT103 | Drug | JMT103, subcutaneous injection, once every 6 months (Q6M) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change rate of lumbar bone mineral density (BMD) from baseline at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change rate of lumbar spine BMD from baseline at 6 months | 6 months | |
| Change rate of total hip and femoral neck BMD from baseline at 12 months | 12 months | |
| Change rate of serum type I collagen cross-linked C-terminal peptide (s-CTX) and procollagen type I N-terminal propeptide (PINP) from baseline at 1, 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunqiang He | Contact | +86-010-63398491 | heshunqiang@mail.ecspc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Alendronate sodium | Drug | Alendronate sodium tablet, once every week (QW) |
|
| JMT103 placebo | Drug | JMT103 placebo, subcutaneous injection, once every 6 months (Q6M) |
|
| Alendronate sodium placebo | Drug | Alendronate sodium tablet placebo, once every week (QW) |
|
| 1, 3, 6 and 12 months |
| Incidence of new fractures at 12 months (vertebral and non-vertebral) | 12 months |
| Types and proportions of adverse events | signing informed consent - 6 months after the last administration |
| JMT103 serum drug concentration | Day 1 - 12 months |
| Incidence of JMT103 anti-drug antibodies (ADA) and neutralizing antibodies (Nab) | Day 1 - 12 months |