Bone FracturePhase 4NCT03845153
Metformin Effect on Fracture Healing in Post-Menopausal Women
A Phase 4 study testing Metformin Retard 850 mg in people with Bone Fracture, run by Damanhour University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women only
- Conditions the study is for
- Bone Fracture
- What is being tested?
- Metformin Retard 850 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range from 55 to less than 65 years old with bone fracture.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Metformin Drug Effect on Fracture Healing in Post-Menopausal Women and Its Correlation to Serum Irisin Myokine Level.
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.
Read the 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.
- Conditions
- Bone Fracture
- Being tested
- Metformin Retard 850 mg, Placebo
- Keywords
- Bone Fracture, Post-Menopausal Women, Metformin, Irisin
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Retard 850 mgDrug
Also called Glucophage
tablet
PlaceboOther
placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Irisin (ng/ml)
myokine/adipokine
Measured: three months
Bone specific alkaline phosphatase (IU/L)
isoenzyme produced by osteoblasts involved with calcification of skeleton and bone formation
Measured: 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
Measured: two months post stabilization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Gamal Omran, Professor, Study director, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845153
- Sponsor's protocol ID
- Metformin on Fracture healing
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2019
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metformin Drug Effect on Fracture Healing in Post-Menopausal Women and Its Correlation to Serum Irisin Myokine Level.
- ClinicalTrials.gov ID
- NCT03845153
- Acronym / sponsor ID
- Metformin on Fracture healing
- Conditions
- Bone Fracture
- Keywords
- Bone Fracture, Post-Menopausal Women, Metformin, Irisin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin Retard 850 mg20 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. |
| Placebo | Placebo comparator | Other: Placebo20 post-menopausal women with a bone fracture treated with placebo once daily for two weeks then twice daily for three months. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age range from 55 to less than 65 years old with bone fracture.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin Retard 850 mgAlso: Glucophagetablet | Drug | Metformin |
| Placeboplacebo tablet | Other | Placebo |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gamal Omran, Professor study director
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin Retard 850 mg in people with Bone Fracture, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Irisin (ng/ml) (time frame: three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.