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NCT05866029 | Not yet recruiting | Osteoporotic Fractures

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

Peking Union Medical College Hospital

Brief 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.

Condition or disease

Osteoporotic Fractures

Intervention/treatment

Denosumab

Teriparatide

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 2310 participants
Masking : Single
Primary Purpose : Prevention
Official Title : Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
Actual Study Start Date : June 2, 2023
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025
Arm Intervention/treatment

Active Comparator: 60mg of Denosumab treatment

Drug: Denosumab

Experimental: Teriparatide was sequentially treated with Denosumab

Drug: Denosumab
Ages Eligible for Study: 45 Years to 90 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • New brittle hip fractures;
  • New brittle vertebral fractures;
  • New other site fractures and/or total hip or neck of femur or L1-L4 T-value < -1.0;
  • Men or postmenopausal women;
  • Age 45-90 years old;
  • Ability to move autonomously
Exclusion Criteria
  • bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome, c.hyperprolactinemia;
  • Having primary hyperparathyroidism or hypothyroidism;
  • Had or have osteomyelitis of the jaw or necrosis of the jaw;
  • GFR<30ml/min/1.73m2;
  • Active infection that requires systematic treatment;
  • Used intravenous bisphosphonate, fluoride, or strontium for osteoporosis within 2 years;
  • Used teriparatide and denosumab for osteoporosis within 6 months;
  • The time gap between the first time and the last time oral bisphosphonate for osteoporosis less than 1 year;
  • Patients with malignant tumors or bone metastases within 5 years, except tumors that are expected to be cured after treatment;
  • Have hypocalcemia and hypercalcemia;
  • Unexplained elevation of alkaline phosphatase;
  • A serious deficiency of vitamin D (25OHD <10ng/mL);
  • Patients who have previously received external radiation or radiation therapy with bone implants;
  • Uncontrolled comorbidities included heart failure above the New York cardiac Function Scale, glycosylated hemoglobin > 8.5%, and severe arrhythmias;
  • Planned pregnancy and lactation at present or during the study period;
  • Allergic to teriparatide and denosumab;
  • Participating in clinical trials of other drugs at present;
  • subjects do not suitable for this study
Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture

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

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