Metformin Effect on Fracture Healing in Post-Menopausal Women

Damanhour University

Status and phase: Completed; Phase 4

Conditions: Bone Fracture

Treatments: Drug: Metformin Retard 850 mg; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03845153

Metformin on Fracture healing

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Metformin

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin Retard 850 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo