Serum Sclerostin Level & Treatment of Vitamin D Deficiency

Serum Sclerostin Level in Patients With Vitamin D Deficiency

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01553344

Acronym

OMSOST

Enrollment

Registered

2012-03-14

Start date

2012-03-31

Completion date

2013-11-30

Last updated

2014-12-23

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

Conditions

Endocrine System Diseases, Vitamin D Deficiency

Keywords

sclerostin, osteomalacia, vitamin D deficiency

Brief summary

The aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D. Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with calcium and vitamin D will be included in the study. This is an observational study. The serum sclerostin levels will be measured before and after Vitamin D treatment.

Detailed description

This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board. This study will be completed with patients with Vitamin D deficiency. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained before and after treatment. Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of serum will be added to eppendorf tubes and stored at -20°C. Serum sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically \<0.012 ng/ml. Intra-assay precision is less than 8%.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Premenopausal * Serum 25(OH)D \< 10 ng/mL

Exclusion criteria

* Anemia * Tumor-induced osteomalacia (hypophosphatemia) * Hypothyroidism * Hepatic / renal disease * Primary hyperparathyroidism * Fibromyalgia * Polymyalgia rheumatica * Serum 25(OH)D \> 10 ng/mL * Vitamin D and calcium treatment commenced prior to study participation

Design outcomes

Primary

Measure	Time frame	Description
Serum sclerostin level	8 weeks	Changes in serum sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia

Countries

Turkey (Türkiye)

Outcome results