Clinical trial NCT03845153: Metformin Effect on Fracture Healing in Post-Menopausal Women
Official title: Study of Metformin Drug Effect on Fracture Healing in Post-Menopausal Women and Its Correlation to Serum Irisin Myokine Level.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bone Fracture
Keywords: Bone Fracture
Post-Menopausal Women
Metformin
Irisin
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Human Irisin (ng/ml)
timeFrame: three months
measure: Bone specific alkaline phosphatase (IU/L)
timeFrame: three months
measure: postoperative X-rays - Lane and Sandhu radiological scoring system
timeFrame: two months post stabilization.
Secondary outcomes:
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Medical National Institute
state: El-Bahairah
Study officials:
affiliation: Damanhour University
name: Gamal Omran, Professor
role: STUDY_DIRECTOR
References: