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NCT05550506 Clinical Trial

Duloxetine on Bone Metabolism

Chronic Pain Clinical Trial

Official title:
The Effect of Duloxetine on Bone Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05550506
Other study ID # Duloxetine on Bone Metabolism
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 27, 2022
Est. completion date December 25, 2022

Study information
Verified date September 2022
Source Cukurova University
Contact Bayram Kelle, Assoc. Prof.
Phone 903223386060-3161
Email bayramkelle@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 102
Est. completion date December 25, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Duloxetine
Patients who use duloxetine for chronic pain or fibromyalgia

Locations
Country Name City State
Turkey Çukurova Üniversitesi Adana

Sponsors (1)
Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary DXA Bone mineral densitomtry 3 months
Primary CTX C-terminal telopeptide 3 months
Primary OC Osteocalcin 3 months
Primary 25-OH VITD3 25-hydroxyvitamin D3 3 months
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