Bone Fracture
Conditions
Keywords
Bone Fracture, Post-Menopausal Women, Metformin, Irisin
Brief summary
study the effect of metformin drug on fracture healing of patients with high risk of delayed fracture healing or non-union and correlating this to serum irisin myokine level.
Detailed description
1. Approval will be obtained from Ethics Committee of general organization of teaching hospitals and institutes and Research Ethics Committee of Faculty of Pharmacy, Damanhour University. 2. Getting informed consent from all participants to take part in this study. 3. Two groups each of 20 post-menopausal women with a bone fracture. One group will be treated randomly with metformin Retard 850 mg once daily for two weeks then 850 mg twice daily. The other group will be untreated and served as control group. 4. Venous blood samples will be taken from each patient before fracture stabilization and later for determination of serum irisin level with corresponding radiological evaluations. Inclusion criteria: • Age range from 55 to less than 65 years old with bone fracture. Exclusion criteria: * Age equal or less than 55 years * Age equal or more than 65 years * Unstable or hospitalized patients with heart failure * Hepatic impairment * Chronic kidney disease with eGFR \<45 mL/minute/1.73 m2 * Open fractures * Pathological fractures * Diabetic patients Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. Methodology: * Active Human Irisin ELISA kit will be used. * Bone-specific Alkaline phosphatase BAP * Serum creatinine, serum albumin, prothrombin time. * Fasting insulin, fasting blood glucose and Calcium level. * BMI, weight, waist, waist-hip ratio, total cholesterol and low-density-lipoprotein cholesterol. * radiological scoring system will be used to evaluate the degree of new bone formation in the fracture line on anterior-posterior and lateral radiographs will be taken two months post stabilization.
Interventions
DRUGMetformin Retard 850 mg
tablet
OTHERPlacebo
placebo tablet
Sponsors
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
double-blind perspective study
Intervention model description
40 post-menopausal women with a bone fracture divided into two groups each of 20, randomly assigned to administration with metformin Retard 850 mg once daily for two weeks then 850 mg twice daily or with placebo.
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age range from 55 to less than 65 years old with bone fracture.
Exclusion criteria
* Age equal or less than 55 years * Age equal or more than 65 years * Unstable or hospitalized patients with heart failure * Hepatic impairment * Chronic kidney disease with eGFR \<45 mL/minute/1.73 m2 * Open fractures * Pathological fractures * Diabetic patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Irisin (ng/ml) | three months | myokine/adipokine |
| Bone specific alkaline phosphatase (IU/L) | three months | isoenzyme produced by osteoblasts involved with calcification of skeleton and bone formation |
| postoperative X-rays - Lane and Sandhu radiological scoring system | two months post stabilization. | evaluate the degree of new bone formation in the fracture line on anterior-posterior and lateral radiographs |
Countries
Egypt
Outcome results
None listed