Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis (NCT05397938) | Clinical Trial Compass
UnknownPhase 2
Efficacy and Safety of JMT103 in the Treatment of Glucocorticoid Induced Osteoporosis
China231 participantsStarted 2022-06-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Both genders aged 18 years or above, capable of autonomous action;
* 2\. In the course of an ongoing glucocorticoid treatment for at least 3months with prednisone≥7.5 mg or its equivalent taken currently, and expected to be treated of no less than 6 months in total;
* 3\. Any of the followings: a. History of osteoporotic fracture; b. Age≥50 years and lumbar (L1-L4) or total hip BMD of T≤-2.0 by DXA; c. Age≥40 years and a predicted 10-year risk of major osteoporotic fractures ≥ 10% (vertebral body, forearm, hip, shoulder) or a predicted 10-year risk of hip fracture ≥ 1% estimated by hormone adjusted FRAX;
* 4\. At least two lumbar vertebrae from L1 to L4 evaluable by DXA;
* 5\. Uncompromised ability to maintain good communication with investigator and comply with all required study procedures;
* 6\. A signed informed consent under the capability of thorough understanding.
Exclusion Criteria:
* 1\. Currently pregnant or lactating; For those of child bearing potential, refusal to use effective forms of contraception from signing informed consent to 6 months after last administration;
* 2\. Previous or ongoing osteomyelitis or necrosis of jaw; Unhealed dental/oral operation wound; Acute jaw bone or dental disease requiring oral surgery; Planned invasive dental surgery during the study period;
* 3\. Selected into other clinical studies of which the latest administration is less than 4 weeks (or 5 elimination half-lives, whichever is longer) from the fi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change rate of lumbar bone mineral density (BMD) from baseline at 12 months