Metformin Effect on Fracture Healing in Post-Menopausal Women

NCT03845153 | Completed Phase 4 DMC

• 1 other identifier: Metformin on Fracture healing
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Fracture

Keywords

Bone Fracture; Post-Menopausal Women; Metformin; Irisin

Outcome Measures

Primary Outcomes (3)

• Human Irisin (ng/ml)

  myokine/adipokine

  three months

• Bone specific alkaline phosphatase (IU/L)

  isoenzyme produced by osteoblasts involved with calcification of skeleton and bone formation

  three months

• postoperative X-rays - Lane and Sandhu radiological scoring system

  evaluate the degree of new bone formation in the fracture line on anterior-posterior and lateral radiographs

  two months post stabilization.

Study Arms (2)

Metformin

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Metformin Retard 850 mg DRUG

tablet

Also known as: Glucophage

Metformin

Placebo OTHER

placebo tablet

Placebo

Eligibility Criteria

• Age: 55 Years - 65 Years
• Gender Eligibility Details: post-menopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 55 to less than 65 years old with bone fracture.

You may not qualify if:

• 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

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhour Medical National Institute

Damanhūr, El-Bahairah, 31527, Egypt

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Metformin

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Gamal Omran, Professor

  Damanhour University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double-blind perspective study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)