Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · May 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying ways to prevent and treat fractures that occur in people with osteoporosis, a condition that makes bones weak and more likely to break. The researchers aim to collect information on patients with new fractures and explore effective treatment strategies through various studies. They will also look into specific biological markers and imaging techniques that might help predict who is at risk for further fractures.

To participate in this trial, you need to be between 45 and 90 years old and have recently experienced certain types of fractures, such as hip or vertebral fractures. The study is open to all genders, but some health conditions would make you ineligible, like certain bone diseases or severe kidney problems. If you join, you can expect to be part of important research that could lead to better treatment options for osteoporosis in the future. Your participation could help improve care for many others facing similar challenges.

Gender

ALL

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 \&gt;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 \&lt;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 \&gt; 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