Duloxetine on Bone Metabolism

Recruiting

• Conditions: Chronic Pain; Fibromyalgia
• Interventions: Drug: Duloxetine

• Registration Number: NCT05550506
• Lead Sponsor: Cukurova University

Brief Summary

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 Timeline

• Study Start: 2022-07-27
• Status Verified: 2022-09
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 102

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Duloxetine Group	Duloxetine	Patients who use duloxetine at least 3 months for chronic pain or fibromyalgia

Primary Outcome Measures

Name	Time	Method
DXA	3 months	Bone mineral densitomtry
CTX	3 months	C-terminal telopeptide
OC	3 months	Osteocalcin
25-OH VITD3	3 months	25-hydroxyvitamin D3

Trial Locations

Locations (1)

Çukurova Üniversitesi; 🇹🇷 Adana, Turkey