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Prevention study for Osteoporotic Fractures
Official title Study of the Key Techniques of Prevention and Treatment of Osteoporotic Refracture
ClinicalTrials.gov ID: NCT05866029
What this study is testing
What is Denosumab?
Denosumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for osteoporotic fractures.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 90
You may be able to join if
- 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;
You likely can't join if
- bone metabolic diseases except for osteoporosis eg. a. (Osteogenesis Imperfecta, Paget's disease, Osteomalacia), b. Cushing's syndrome...
- 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;
See the full eligibility 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
- 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;
- Used glucocorticoids (equivalent to \>5 mg/day prednisone) for more than 10 days within 6 weeks;
- 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) ;
- 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;
- people do not suitable for this study
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changchun, China
- Changsha, China
- Changzhou, China
- Chengdu, China
- Dalian, China
- Dongying, China
- Guiyang, China
- Guizhou, China
- Haerbin, China
- Hangzhou, China
- Hefei, China
- Hohhot, China
- Jinan, China
- Jining, China
- Lanzhou, China
- Liaocheng, China
- Nanchang, China
- Nanjing, China
- Ningbo, China
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changchun, China; Changsha, China; Changzhou, China; Chengdu, China; Dalian, China and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.