Chronic PainNCT05550506
Duloxetine on Bone Metabolism
An observational study of Chronic Pain and Fibromyalgia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to determine the effect of duloxetine as monotherapy on biochemical markers and bone mineral density. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Fibromyalgia
- What is being tested?
- Duloxetine
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2022to 25 Dec 2022
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who use duloxetine for at least 3 months due to chronic pain or fibromyalgia
Who may be able to join
- >18 years or <50 years
- patients using duloxetine for at least 3 months due to chronic pain or fibromyalgia
Who cannot join
- postmenopausal women
- clinical conditions which cause secondary osteoporosis
- patients using medication that cause secondary osteoporosis
- pregnancy and malignity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Çukurova Üniversitesi
Adana
Bayram Kelle, bayramkelle@yahoo.com
About this study
Official title: The Effect of Duloxetine on Bone Metabolism
The aim of the study was to determine the effect of duloxetine as monotherapy on biochemical markers and bone mineral density.
Read the detailed description
51 patients diagnosed with chronic pain or fibromyalgia syndrome who were using duloxetine for at least 3 months and age and sex matched 51 healthy individuals were recruited for this cross-sectional study. Bone mineral density of both groups were measured by dual energy x ray absorbsiometry(DXA), bone biochemical markers, serum calcium, and vitamin D levels were investigated.
- Conditions
- Chronic Pain, Fibromyalgia
- Being tested
- Duloxetine
- Keywords
- duloxetine, chronic pain, fibromyalgia, bone metabolism
- Medical subject headings
- Chronic Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Patients who use duloxetine for chronic pain or fibromyalgia
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine Group | Patients who use duloxetine at least 3 months for chronic pain or fibromyalgia Receives: Drug: Duloxetine | |
| Healthy Group | Age and sex matched 51 healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
DXA
Bone mineral densitomtry
Measured: 3 months
CTX
C-terminal telopeptide
Measured: 3 months
OC
Osteocalcin
Measured: 3 months
25-OH VITD3
25-hydroxyvitamin D3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start27 Jul 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion25 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bayram Kelle, Cukurova University
- Investigators
- Burak Demir, Dr., Principal investigator, Cukurova University Faculty of Medicine Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550506
- Sponsor's protocol ID
- Duloxetine on Bone Metabolism
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Duloxetine on Bone Metabolism
- ClinicalTrials.gov ID
- NCT05550506
- Acronym / sponsor ID
- Duloxetine on Bone Metabolism
- Conditions
- Chronic Pain, Fibromyalgia
- Keywords
- duloxetine, chronic pain, fibromyalgia, bone metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 25 Dec 2022 (estimated)
- First posted
- 22 Sep 2022 (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.
The aim of the study was to determine the effect of duloxetine as monotherapy on biochemical markers and bone mineral density.
Detailed description
51 patients diagnosed with chronic pain or fibromyalgia syndrome who were using duloxetine for at least 3 months and age and sex matched 51 healthy individuals were recruited for this cross-sectional study. Bone mineral density of both groups were measured by dual energy x ray absorbsiometry(DXA), bone biochemical markers, serum calcium, and vitamin D levels were investigated.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine Group | – | Drug: DuloxetinePatients who use duloxetine at least 3 months for chronic pain or fibromyalgia |
| Healthy Group | – | –Age and sex matched 51 healthy individuals |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who use duloxetine for at least 3 months due to chronic pain or fibromyalgia
Key inclusion criteria (2 listed)
- >18 years or <50 years
- patients using duloxetine for at least 3 months due to chronic pain or fibromyalgia
Key exclusion criteria (4 listed)
- postmenopausal women
- clinical conditions which cause secondary osteoporosis
- patients using medication that cause secondary osteoporosis
- pregnancy and malignity
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 |
|---|---|---|
| DuloxetinePatients who use duloxetine for chronic pain or fibromyalgia | Drug | Duloxetine Group |
Primary outcome
DXA
Time frame: 3 months
Bone mineral densitomtry
CTX
Time frame: 3 months
C-terminal telopeptide
OC
Time frame: 3 months
Osteocalcin
25-OH VITD3
Time frame: 3 months
25-hydroxyvitamin D3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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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.
Burak Demir, Dr. principal investigator
Cukurova University Faculty of Medicine Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Fibromyalgia, run by Cukurova University at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Sep 2022. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bayram Kelle, Assoc. Prof. (903223386060-3161, bayramkelle@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DXA (time frame: 3 months). The study lists 4 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 22 Sep 2022.