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

Osteoporotic Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05866029
• Other study ID #: 2022-PUMCH-D-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2310
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporotic Fractures

Intervention

Drug:
• Denosumab
Active Comparator: 60mg of Denosumab treatment by subcutaneous injection
• Teriparatide
Teriparatide was sequentially treated with Denosumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of new vertebral fractures	The incidence of new vertebral fractures (clinical and imaging) within 24 months of treatment	Within 24 months of treatment