Metformin Effect on Fracture Healing in Post-Menopausal W... | NCT03845153

Studies
Metformin Effect on Fracture Healing in Post-Menopausal Women

NCT03845153

Sponsor

Damanhour University

Status

Completed

Last Update Posted

Feb 9, 2021Actual

Enrollment

40Actual

Phase

Phase 4

Conditions

Bone Fracture

Interventions

Metformin Retard 850 mg
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Feb 15, 2019

First Submission Date that Met QC Criteria

Feb 15, 2019

First Posted Date

Feb 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 5, 2021

Last Update Posted Date

Feb 9, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rehab Werida, Principal Investigator, Damanhour UniversityPrincipal Investigator

Lead Sponsor

Damanhour UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Metformin Retard 850 mg	Drug	tablet	Metformin	Glucophage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

post-menopausal women

Minimum Age

55 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gamal Omran, Professor	Damanhour University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Damanhour Medical National Institute		Damanhūr	El-Bahairah	31527	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

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.