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Completed

NCT Number: NCT03845153

Metformin Effect on Fracture Healing in Post-Menopausal Women

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.

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Key information

Conditions

Bone Fracture Fractures, Bone Wounds and Injuries

Age range

55 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Damanhour Medical National Institute

Damanhūr, El-Bahairah, 31527, Egypt

About this study

  • 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.
  • Getting informed consent from all participants to take part in this study.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metformin Retard 850 mg

Drug

tablet

Other names: Glucophage

Placebo

Other

placebo tablet

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 19, 2019
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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