Clinical trial

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

Name
2022-PUMCH-D-004
Description
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.
Trial arms
Trial start
2023-06-02
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Not yet recruiting
Treatment
Denosumab
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
Arms:
60mg of Denosumab treatment, Teriparatide was sequentially treated with Denosumab
Teriparatide
Teriparatide was sequentially treated with Denosumab
Arms:
Teriparatide was sequentially treated with Denosumab
Size
2310
Primary endpoint
The incidence of new vertebral fractures
Within 24 months of treatment
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. 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 2310, 'type': 'ESTIMATED'}}
Updated at
2023-05-19

1 organization

2 products

1 indication

Product
Denosumab