NCT05550506

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

September 19, 2022

Last Update Submit

September 19, 2022

Conditions

Chronic PainFibromyalgia

Keywords

duloxetinechronic painfibromyalgiabone metabolism

Outcome Measures

Primary Outcomes (4)

  • DXA

    Bone mineral densitomtry

    3 months

  • CTX

    C-terminal telopeptide

    3 months

  • OC

    Osteocalcin

    3 months

  • 25-OH VITD3

    25-hydroxyvitamin D3

    3 months

Study Arms (2)

Duloxetine Group

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

Drug: Duloxetine

Healthy Group

Age and sex matched 51 healthy individuals

Interventions

DuloxetineDRUG

Patients who use duloxetine for chronic pain or fibromyalgia

Duloxetine Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • postmenopausal women
  • clinical conditions which cause secondary osteoporosis
  • patients using medication that cause secondary osteoporosis
  • pregnancy and malignity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Çukurova Üniversitesi

Adana, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chronic PainFibromyalgia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Burak Demir, Dr.

    Cukurova University Faculty of Medicine Department of Physical Medicine and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bayram Kelle, Assoc. Prof.

CONTACT

903223386060-3161bayramkelle@yahoo.com

Bayram Kelle, Assoc. Prof

CONTACT

903223386060-3161bayramkelle@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 22, 2022

Study Start

July 27, 2022

Primary Completion

October 1, 2022

Study Completion

December 25, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Locations

TU(1)