Duloxetine on Bone Metabolism

NCT ID: NCT05550506

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-27

Study Completion Date

2022-12-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study was to determine the effect of duloxetine as monotherapy on biochemical markers and bone mineral density.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Duloxetine Group

Patients who use duloxetine at least 3 months for chronic pain or fibromyalgia

Duloxetine

Intervention Type DRUG

Patients who use duloxetine for chronic pain or fibromyalgia

Healthy Group

Age and sex matched 51 healthy individuals

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Duloxetine

Patients who use duloxetine for chronic pain or fibromyalgia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>18 years or \<50 years
* patients using duloxetine for at least 3 months due to chronic pain or fibromyalgia

Exclusion Criteria

* postmenopausal women
* clinical conditions which cause secondary osteoporosis
* patients using medication that cause secondary osteoporosis
* pregnancy and malignity
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cukurova University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bayram Kelle

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Burak Demir, Dr.

Role: PRINCIPAL_INVESTIGATOR

Cukurova University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Çukurova Üniversitesi

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bayram Kelle, Assoc. Prof.

Role: CONTACT

903223386060-3161

Bayram Kelle, Assoc. Prof

Role: CONTACT

903223386060-3161

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bayram Kelle

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Duloxetine on Bone Metabolism

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Osteosarcopenia and Exercise
NCT04526327 COMPLETED NA