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Status unknownNCT05716750Updated Feb 14, 2023

Serum Prolidase Activity and the Role of Leptin in Osteomalacia

An interventional study of Vitamin D in Osteomalacia, sponsored by TUĞBA ŞAHBAZ. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-14.

Sponsored by TUĞBA ŞAHBAZ · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Osteomalacia

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03

In context

Osteomalacia

34 studies on the registry are indexed under Osteomalacia; 3 are open to participants now.

This study's planned enrollment of 38 is above the median of 15 across 17 interventional studies indexed under Osteomalacia.

Browse Osteomalacia studies →

Lead sponsor

This is the only study on the registry with TUĞBA ŞAHBAZ as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (estimated)

Study arms

  • Other
    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.

    Dietary Supplement: Vitamin D

Interventions

  • Dietary supplementVitamin D

    50,000 IU vit D treatment for 8 weeks

    Also known as: vit D treatment

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What researchers measure

Primary outcomes

  1. Serum Prolidase activity

    Prolidase activity

    Time frame: 8 weeks

  2. Serum Leptin

    Leptin

    Time frame: 8 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05716750
Lead sponsor
TUĞBA ŞAHBAZ
Responsible party
TUĞBA ŞAHBAZ (assist. prof. dr, University of Beykent) — Sponsor-investigator
First posted
Feb 8, 2023
Start date
Feb 15, 2023 (estimated)
Primary completion
Apr 30, 2023 (estimated)
Completion
Jun 30, 2023 (estimated)
Last update
Feb 14, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin D

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