Study of Metformin Drug Effect on Fracture Healing in Post-Menopausal Women and Its Correlation to Serum Irisin Myokine Level.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Damanhour University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Human Irisin (ng/ml)
Study Overview
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
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
double-blind perspective study
Eligibility Criteria
- Ages
- 55 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Metformin Retard 850 mg (Drug)
Placebo
20 post-menopausal women with a bone fracture treated with placebo once daily for two weeks then twice daily for three months.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Human Irisin (ng/ml)
Time Frame: three months
myokine/adipokine
Bone specific alkaline phosphatase (IU/L)
Time Frame: three months
isoenzyme produced by osteoblasts involved with calcification of skeleton and bone formation
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Rehab Werida
Principal Investigator
Damanhour University