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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03845153
Other study ID # Metformin on Fracture healing
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2019
Est. completion date January 1, 2021

Study information

Verified date February 2021
Source Damanhour University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 55 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metformin Retard 850 mg
tablet
Other:
Placebo
placebo tablet

Locations

Country Name City State
Egypt Damanhour Medical National Institute Damanhur El-Bahairah

Sponsors (1)

Lead Sponsor Collaborator
Damanhour University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Human Irisin (ng/ml) myokine/adipokine three months
Primary Bone specific alkaline phosphatase (IU/L) isoenzyme produced by osteoblasts involved with calcification of skeleton and bone formation three months
Primary 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.
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