Metformin Effect on Fracture Healing in Post-Menopausal Women

Bone Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03845153
• Other study ID #: Metformin on Fracture healing
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone

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.