Duloxetine on Bone Metabolism | NCT05550506

Studies
Duloxetine on Bone Metabolism

NCT05550506

Sponsor

Cukurova University

Status

Unknown status

Last Update Posted

Sep 22, 2022Actual

Enrollment

102Estimated

Phase

Not provided

Conditions

Chronic Pain
Fibromyalgia

Interventions

Duloxetine

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2022Actual

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Dec 25, 2022Estimated

First Submitted Date

Sep 19, 2022

First Submission Date that Met QC Criteria

Sep 19, 2022

First Posted Date

Sep 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2022

Last Update Posted Date

Sep 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

102Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine	Drug	Patients who use duloxetine for chronic pain or fibromyalgia	Duloxetine Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bayram Kelle, Assoc. Prof.	Contact	903223386060-3161		bayramkelle@yahoo.com
Bayram Kelle, Assoc. Prof	Contact	903223386060-3161		bayramkelle@yahoo.com

Overall Officials

Name	Affiliation	Role
Burak Demir, Dr.	Cukurova University Faculty of Medicine Department of Physical Medicine and Rehabilitation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Çukurova Üniversitesi	Recruiting	Adana			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain
D005356	Fibromyalgia

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068736	Duloxetine Hydrochloride

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided