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Serum Prolidase Activity and the Role of Leptin in Osteomalacia

Primary Purpose

Osteomalacia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
TUĞBA ŞAHBAZ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteomalacia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Osteomalasia

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Serum Prolidase activity
    Prolidase activity
    Serum Leptin
    Leptin

    Secondary Outcome Measures

    Full Information

    First Posted
    January 9, 2023
    Last Updated
    February 10, 2023
    Sponsor
    TUĞBA ŞAHBAZ
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05716750
    Brief Title
    Serum Prolidase Activity and the Role of Leptin in Osteomalacia
    Official Title
    Serum Prolidase Activity and the Role of Leptin in Osteomalacia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 15, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    TUĞBA ŞAHBAZ

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteomalacia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Osteomalasia
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin D
    Other Intervention Name(s)
    vit D treatment
    Intervention Description
    50,000 IU vit D treatment for 8 weeks
    Primary Outcome Measure Information:
    Title
    Serum Prolidase activity
    Description
    Prolidase activity
    Time Frame
    8 weeks
    Title
    Serum Leptin
    Description
    Leptin
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Serum Prolidase Activity and the Role of Leptin in Osteomalacia

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