Serum Prolidase Activity and the Role of Leptin in Osteomalacia

NCT ID: NCT05716750

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2023-06-30

Brief Summary

Evaluation of the change of serum Prolidase and Leptin values in the diagnosis and follow-up of osteomalacia and its clinical usability

Detailed Description

Osteomalacia describes a bone disorder in adults that is usually caused by long-term vitamin D deficiency. Osteomalacia, a metabolic bone disease characterized by impaired mineralization of the bone matrix.Not a single laboratory finding is specific to osteomalacia.The relationship between collagen and prolidase activity has been observed during fibrotic processes, where an increase in prolidase activity is accompanied by an increase in tissue collagen deposition. It has also been suggested that serum activity is increased in metabolic bone diseases.Leptin is a 16 kDa peptide hormone. It is a member of the long chain helical cytokine family, which is mainly produced by fat cells and proportional to the size of the stored fat. Leptin affects bone remodeling by reducing the activity of osteoclasts and thus participates in the pathogenesis of osteoporosis. In the light of these studies, the investigators planned our study according to the clinical significance of serum prolidase activity in osteomalacia and the place of leptin in osteomalacia.

Conditions

Osteomalacia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osteomalasia

Our study, which is the only group planned prospectively, aims to compare clinical and laboratory data and serum prolidase activity and leptin levels in 38 patients diagnosed with osteomalacia after and before 8 weeks of 50,000 IU D vit treatment.

Group Type: OTHER

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

50,000 IU vit D treatment for 8 weeks

Interventions

Vitamin D

50,000 IU vit D treatment for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

vit D treatment

Eligibility Criteria

Inclusion Criteria

• Among the patients who applied to the outpatient clinic, those with clinical complaints of osteomalacia (diffuse pain, fatigue, rapid fatigue, proximal extremity weakness, etc.)
• 25 0H vit. D level of 10ng/ml and below

Exclusion Criteria

• Other metabolic and endocrine bone diseases (secondary osteoporosis, paget hast, osteogenesis imperfecta, osteomyelitis etc.)
• Patients who have previously received treatment for low vitamin d
• Those with low vitamin D levels due to liver or kidney failure
• Those who receive treatment for tumor

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TUĞBA ŞAHBAZ

OTHER

Sponsor Role: lead

Responsible Party

TUĞBA ŞAHBAZ

assist. prof. dr

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

KAEK/2022.12.233

Identifier Type: -

Identifier Source: org_study_id