Metformin Effect on Fracture Healing in Post-Menopausal Women

• ClinicalTrials.gov Identifier: NCT03845153
• Recruitment Status: Completed
• First Posted: February 19, 2019
• Last Update Posted: February 9, 2021
• Sponsor: Damanhour University
• Information provided by (Responsible Party): Rehab Werida, Damanhour University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bone Fracture	Drug: Metformin Retard 850 mg; Other: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant, Outcomes Assessor)
• Masking Description: double-blind perspective study
• Primary Purpose: Treatment
• Official Title: Study of Metformin Drug Effect on Fracture Healing in Post-Menopausal Women and Its Correlation to Serum Irisin Myokine Level.
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: January 1, 2021
• Actual Study Completion Date: January 1, 2021

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: post-menopausal women
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Egypt

Damanhour Medical National Institute

Damanhūr, El-Bahairah, Egypt, 31527

Sponsors and Collaborators

Damanhour University

Investigators

• Study Director: Gamal Omran, Professor; Damanhour University

More Information

• Responsible Party: Rehab Werida, Principal Investigator, Damanhour University
• ClinicalTrials.gov Identifier: NCT03845153
• Other Study ID Numbers: Metformin on Fracture healing
• First Posted: February 19, 2019
• Last Update Posted: February 9, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rehab Werida, Damanhour University:

Bone Fracture; Post-Menopausal Women; Metformin; Irisin

Additional relevant MeSH terms:

Fractures, Bone; Wounds and Injuries; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs