Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture (NCT05866029) | Clinical Trial Compass
RecruitingNot Applicable
Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
China2,478 participantsStarted 2023-05-26
Plain-language summary
This project anchors osteoporotic fractures, conduct registration and follow-up studies, and conduct prospective treatment studies. By registering for follow-up studies on osteoporotic fractures, it is planned to obtain epidemiological data through registration and follow-up studies; A prospective treatment study for patients with osteoporotic fractures is planned to explore effective treatment strategies through randomized controlled trials; To study biomarkers for osteoporotic refractures, we plan to establish a biomarker warning model through multi omics research; To study imaging biomarkers for osteoporotic refractures, a new imaging technology is proposed to establish an imaging omics warning model.
Who can participate
Age range45 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. New brittle hip fractures;
✓. New brittle vertebral fractures;
✓. New other site fractures and/or total hip or neck of femur or L1-L4 T-value \< -1.0;
✓. Men or postmenopausal women;
✓. Age 45-90 years old;
✓. Ability to move autonomously
Exclusion criteria
✕. bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
✕. Having primary hyperparathyroidism or hypothyroidism;
✕. Had or have osteomyelitis of the jaw or necrosis of the jaw;
✕. GFR\<30ml/min/1.73m2;
✕. Active infection that requires systematic treatment;
What they're measuring
1
The main study：The incidence of new vertebral fractures
Timeframe: Within 24 months of treatment
2
The sub study：The rate of change in BMD from baseline at lumbar spine in 24 months