Duloxetine on Bone Metabolism

• Sponsor: Cukurova University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05550506
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 20.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Fibromyalgia	Drug: Duloxetine

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 Design

• Study Type: Observational
• Anticipated Enrollment: 102 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: The Effect of Duloxetine on Bone Metabolism
• Actual Study Start Date: Jul 27, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 25, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. DXA [3 months]

   Bone mineral densitomtry

2. CTX [3 months]

   C-terminal telopeptide

3. OC [3 months]

   Osteocalcin

4. 25-OH VITD3 [3 months]

   25-hydroxyvitamin D3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Çukurova Üniversitesi	Adana		Turkey

Sponsors and Collaborators

• Cukurova University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayram Kelle, Associate Professor, Cukurova University
• ClinicalTrials.gov Identifier: NCT05550506
• Other Study ID Numbers: Duloxetine on Bone Metabolism
• First Posted: Sep 22, 2022
• Last Update Posted: Sep 22, 2022
• Last Verified: Sep 1, 2022

• 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
• Keywords provided by Bayram Kelle, Associate Professor, Cukurova University: duloxetine; chronic pain; fibromyalgia; bone metabolism
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Chronic Pain; Duloxetine Hydrochloride

Study Results

No Results Posted as of Sep 22, 2022