Study on the Correlation of Free Vitamin d With BMD and Fracture

Study Overview
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Brief Summary
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According to the free hormone hypothesis, the biological activity of a hormone is carried by the portion that is not bound to protein or its carrier in circulation. Based on this, we believe that the free vitamin d, which is the proportion of Vitamin D unbound to vitamin D binding protein and albumin, performs the calcium-regulating functions of the vitamin. Hence, our objective is to study whether free vitamin correlated better with BMD and fracture than the total vitamin D.

Detailed Description
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Osteoporosis is a major health issue worldwide as it increases the risk of fragility fracture and chronic disability. The studies on the association between vitamin d and osteoporosis have yielded conflicting results. While some have shown a positive correlation, others have concluded that there is no association at all. Recent reports have shown vitamin D supplementation do not prevent fragile fractures. This might be because the actual vitamin D status, which should be the free vitamin D, has not been measured.

Official Title
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Free Vitamin D Correlate Better With BMD and Fracture Than Total Serum Vitamin D?

Conditions
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Osteoporosis

Intervention / Treatment
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* Diagnostic Test: free vitamin d test
* Diagnostic Test: total vitamin d


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a diagnosis of osteoporosis and with or without fracture post- menopausal women age > 48 years Exclusion Criteria: vitamin D supplementation in recent 6 months patients on steroid age < 48 years patients with chronic diseases such as liver cirrhosis, renal failure, hypertension, hyperparathyroidism

Ages Eligible for Study
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Minimum Age: 48 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: free vitamin d<br>free vitamin is directly measured from blood serum using an ELISA kit | Diagnostic Test: free vitamin d test<br>* using the patient's blood serum ELISA test for free vitamin d can be performed<br>|
| Experimental: total vitamin d<br>Total vitamin d is measured routinely from blood serum | Diagnostic Test: total vitamin d<br>* routinely measured from serum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free vitamin D | measured using free vitamin D Elisa kit | ! day | 
| Total vitamin D | It is measured as a part of routine investigation at the time of admission | ! day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMD | Bone mineral density is measured using the Dual-energy X-ray absorptiometry | ! day | 
| Vertebral fracture | With the help of plain X-ray | ! day |