Serum Prolidase Activity and the Role of Leptin in Osteomalacia

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05716750

Enrollment

Registered

2023-02-08

Start date

2023-02-15

Completion date

2023-06-30

Last updated

2023-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteomalacia

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.

Interventions

DIETARY_SUPPLEMENTVitamin D

50,000 IU vit D treatment for 8 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Serum Prolidase activity	8 weeks	Prolidase activity
Serum Leptin	8 weeks	Leptin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026