Metformin Effect on Fracture Healing in Post-Menopausal Women

Study Overview
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Brief Summary
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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
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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. Getting informed consent from all participants to take part in this study. 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. 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.

Official Title
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Study of Metformin Drug Effect on Fracture Healing in Post-Menopausal Women and Its Correlation to Serum Irisin Myokine Level.

Conditions
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Bone Fracture

Intervention / Treatment
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* Drug: Metformin Retard 850 mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metformin<br>20 post-menopausal women with a bone fracture treated with metformin Retard 850 mg once daily for two weeks then 850 mg twice daily for three months. | Drug: Metformin Retard 850 mg<br>* tablet<br>* Other names: Glucophage;|
| Placebo Comparator: Placebo<br>20 post-menopausal women with a bone fracture treated with placebo once daily for two weeks then twice daily for three months. | Other: Placebo<br>* placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Irisin (ng/ml) | myokine/adipokine | three months | 
| Bone specific alkaline phosphatase (IU/L) | isoenzyme produced by osteoblasts involved with calcification of skeleton and bone formation | three months | 
| postoperative X-rays - Lane and Sandhu radiological scoring system | evaluate the degree of new bone formation in the fracture line on anterior-posterior and lateral radiographs | two months post stabilization. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone Fracture, Post-Menopausal Women, Metformin, Irisin