NCT05866029 Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
| NCT ID | NCT05866029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking Union Medical College Hospital |
| Condition | Osteoporotic Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,478 participants |
| Start Date | 2023-05-26 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,478 participants in total. It began in 2023-05-26 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. New brittle hip fractures; 2. New brittle vertebral fractures; 3. New other site fractures and/or total hip or neck of femur or L1-L4 T-value \< -1.0; 4. Men or postmenopausal women; 5. Age 45-90 years old; 6. Ability to move autonomously Exclusion Criteria: 1. bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia; 2. Having primary hyperparathyroidism or hypothyroidism; 3. Had or have osteomyelitis of the jaw or necrosis of the jaw; 4. GFR\<30ml/min/1.73m2; 5. Active infection that requires systematic treatment; 6. Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years; 7. Used teriparatide and denosumab for osteoporosis within 6 months; 8. Used glucocorticoids (equivalent to \>5 mg/day prednisone) for more than 10 days within 6 weeks; 9. The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year( if used within one year, but the cumulative use is ≤ 1 month, the subject can be enrolled) ; 10. Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment; 11. Have hypocalcemia and hypercalcemia; 12. Unexplained elevation of alkaline phosphatase; 13. A serious deficiency of vitamin D (25OHD \<10ng/mL); 14. Patients who have previously received external radiation or radiation therapy with bone implants; 15. Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin \> 8.5%, and severe arrhythmias; 16. Planned pregnancy and lactation at present or during the study period; 17. Allergic to teriparatide and denosumab; 18. Participating in clinical trials of other drugs at present; 19. subjects do not suitable for this study
Contact & Investigator
Weibo Xia, MD.
STUDY CHAIR
Peking Union Medical College Hospital
Frequently Asked Questions
Who can join the NCT05866029 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 90 Years, studying Osteoporotic Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05866029 currently recruiting?
Yes, NCT05866029 is actively recruiting participants. Contact the research team at xiaweibo8301@163.com for enrollment information.
Where is the NCT05866029 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT05866029 clinical trial?
NCT05866029 is sponsored by Peking Union Medical College Hospital. The principal investigator is Weibo Xia, MD. at Peking Union Medical College Hospital. The trial plans to enroll 2,478 participants.