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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Denosumab; Teriparatide

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. The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year;

9. Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;

10. Have hypocalcemia and hypercalcemia;

11. Unexplained elevation of alkaline phosphatase;

12. A serious deficiency of vitamin D (25OHD <10ng/mL);

13. Patients who have previously received external radiation or radiation therapy with bone implants;

14. Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin > 8.5%, and severe arrhythmias;

15. Planned pregnancy and lactation at present or during the study period;

16. Allergic to teriparatide and denosumab;

17. Participating in clinical trials of other drugs at present;

18. subjects do not suitable for this study