Serum Prolidase Activity and the Role of Leptin in Osteomalacia

Osteomalacia Clinical Trial

Official title:

Serum Prolidase Activity and the Role of Leptin in Osteomalacia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05716750
• Other study ID #: KAEK/2022.12.233
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2023
• Source: University of Beykent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 38
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteomalacia

Intervention

Dietary Supplement:
• Vitamin D
50,000 IU vit D treatment for 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TUGBA SAHBAZ

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Prolidase activity	Prolidase activity	8 weeks
Primary	Serum Leptin	Leptin	8 weeks