Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures i… (NCT07063797) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes
China358 participantsStarted 2026-02-01
Plain-language summary
This study will conduct a randomized controlled trial targeting patients with type 2 diabetes and a high risk of fractures. The aim is to evaluate the intervention effect of denosumab combined with edilossobulin on patients with a high risk of osteoporotic fractures due to type 2 diabetes, as well as its impact on bone density, bone turnover indicators, the risk of new fractures, and the risk of hypocalcemia. This will provide scientific evidence for clinical diagnosis and treatment, and offer important clinical research evidence for formulating national health policies.
Who can participate
Age range
50 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
. Confirmed diagnosis of type 2 diabetes (based on the "China Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)").
. Males aged ≥50 years; females aged ≥45 years and postmenopausal for more than 2 years.
. Duration of diabetes \>10 years; or presence of at least one of the following conditions: ①diabetic retinopathy; ②urine albumin-to-creatinine ratio (UACR)≥ 30 mg/g; ③estimated glomerular filtration rate (eGFR)\<60 mL/min/1.73 m²; ④coronary atherosclerotic heart disease; ⑤ischemic stroke; ⑥transient ischemic attack; ⑦ atherosclerosis of the carotid, cerebral, or lower-extremity arteries with ≥50% luminal stenosis.
. History of hip or vertebral fragility fractures; or history of fragility fractures at other sites (excluding the skull, feet, and hands) with a T-score of \<-1.0 at the femoral neck, total hip, or any L1-L4 site; or a T-score of \<-2.0 at the femoral neck, total hip, or any L1-L4 site.
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.
. In the BMD measurement at lumbar vertebrae L1-L4, at least two or more vertebral bodies must meet the evaluable criteria.
. Signed informed consent form, willing to participate in the study
Exclusion criteria
. Diseases that cause secondary osteoporosis: a. Various metabolic bone diseases, such as osteomalacia, primary hyperparathyroidism, osteogenesis imperfecta, Paget's disease, etc.; b. Cushing's syndrome; c. Hyperprolactinemia; d. Others;
. Malignant tumors within the past 5 years, except for those expected to be cured after treatment (e.g., completely resected in situ basal cell or squamous cell carcinoma of the skin, cervical cancer, or ductal carcinoma of the breast);
. Received intravenous bisphosphonate treatment within the past 2 years or oral bisphosphonate treatment within the past 1 year;
. History or current diagnosis of osteomyelitis or osteonecrosis of the jaw; unhealed dental or oral surgical wounds; acute dental or jaw conditions requiring oral surgery; planned to undergo invasive dental surgery during the study period;
. Received denosumab, teriparatide, or romosozumab treatment within the past 6 months;
. Continuous use of calcitonin for more than 3 months within the past year;
. Use of glucocorticoids (equivalent to\>5 mg/day prednisone) for more than 10 days within the past 6 weeks;