Metformin Effect on Fracture Healing in Post-Menopausal Women

NCT ID: NCT03845153

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-01-01

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.

Conditions

Bone Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Metformin

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.

Group Type: ACTIVE_COMPARATOR

Metformin Retard 850 mg

Intervention Type: DRUG

tablet

Placebo

20 post-menopausal women with a bone fracture treated with placebo once daily for two weeks then twice daily for three months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo tablet

Interventions

Metformin Retard 850 mg

tablet

Intervention Type: DRUG

Placebo

placebo tablet

Intervention Type: OTHER

Other Intervention Names

Glucophage

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Werida

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gamal Omran, Professor

Role: STUDY_DIRECTOR

Damanhour University

Locations

Damanhour Medical National Institute

Damanhūr, El-Bahairah, Egypt

Countries

Egypt

Other Identifiers

Metformin on Fracture healing

Identifier Type: -

Identifier Source: org_study_id