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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Osteoporotic Fractures

Treatments: Drug: Teriparatide; Drug: Denosumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05866029

2022-PUMCH-D-006

Details and patient eligibility

About

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.

Enrollment: 2,478 estimated patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,478 participants in 2 patient groups

60mg of Denosumab treatment

Active Comparator group

Description:

Monotherapy with denosumab injection ( 60mg, subcutaneous injection, semi-annually) for 24 months.

Treatment:

Drug: Denosumab

Teriparatide was sequentially treated with Denosumab

Experimental group

Description:

1. Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 6 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, once every six months) and continued until the 24th month. 2. Treatment with teriparatide injection ( 20ug, subcutaneous injection, once daily) for 12 months, followed by discontinuation of teriparatide and change to denosumab injection ( 60mg, subcutaneous injection, semi-annually) treatment continued until the 24th month.

Treatment:

Drug: Denosumab

Drug: Teriparatide