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
Organization
Peking Union Medical College HospitalProduct
DenosumabIndication
Osteoporotic fracturesProduct
Teriparatide