Duloxetine on Bone Metabolism

September 19, 2022 updated by: Bayram Kelle, Cukurova University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Duloxetine Group
Patients who use duloxetine at least 3 months for chronic pain or fibromyalgia
Drug: Duloxetine
Patients who use duloxetine for chronic pain or fibromyalgia
Healthy Group
Age and sex matched 51 healthy individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DXA
Time Frame: 3 months
Bone mineral densitomtry
3 months
CTX
Time Frame: 3 months
C-terminal telopeptide
3 months
OC
Time Frame: 3 months
Osteocalcin
3 months
25-OH VITD3
Time Frame: 3 months
25-hydroxyvitamin D3
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Principal Investigator: Burak Demir, Dr., Cukurova University Faculty of Medicine Department of Physical Medicine and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 25, 2022

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Duloxetine on Bone Metabolism

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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