Metformin Effect on Fracture Healing in Post-Menopausal Women

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Fracture
• Intervention / Treatment: Other: Placebo; Drug: Metformin Retard 850 mg

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • El-Bahairah
    • Damanhūr, El-Bahairah, Egypt, 31527
      • Damanhour Medical National Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	Drug: Metformin Retard 850 mg; tablet; Other Names: Glucophage
PLACEBO_COMPARATOR: Placebo; 20 post-menopausal women with a bone fracture treated with placebo once daily for two weeks then twice daily for three months.	Other: Placebo; placebo tablet

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Damanhour University
• Investigators: Study Director: Gamal Omran, Professor, Damanhour University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): January 1, 2021
• Study Completion (ACTUAL): January 1, 2021

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 15, 2019
• First Posted (ACTUAL): February 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Metformin; Irisin; Bone Fracture; Post-Menopausal Women
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: Metformin on Fracture healing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No