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Plasma Sclerostin Level & Treatment of Osteomalacia (OMSOST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01553344
First received: March 12, 2012
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

The aim of this study is to determine plasma sclerostin levels and change in plasma sclerostin levels in patients with osteomalacia treated with calcium and vitamin D.

Patients with osteomalacia diagnosed and routinely treated with calcium and vitamin D will be included in the study. This is an observational study. The plasma sclerostin levels will be measured before and after osteomalacia treatment.


Condition
Endocrine System Diseases
Osteomalacia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Plasma Sclerostin Level in Patients With Osteomalacia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bagcilar Training and Research Hospital:

Primary Outcome Measures:
  • Plasma sclerostin level [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Changes in plasma sclerostin level in patients with osteomalacia who are scheduled for routine treatment of osteomalacia


Enrollment: 40
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
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 40 patients with osteomalacia. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained before and after treatment.

Plasma will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of plasma will be added to eppendorf tubes and stored at -20°C.

Plasma 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%.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with osteomalacia

Criteria

Inclusion Criteria:

  • Patients with osteomalacia who are scheduled for routine treatment of osteomalacia
  • Volunteer

Exclusion Criteria:

  • Endocrinopathies
  • Bone disease (osteoporosis, paget disease etc)
  • Patients who started treatment of vitamin D and calcium before the study
  • Tumor induced osteomalacia
  • Low serum Vitamin D level due to renal or hapatic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553344

Locations
Turkey
Bagcilar Training & Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Bagcilar Training and Research Hospital
Investigators
Principal Investigator: MUHARREM CIDEM, MD Bagcilar Training & Research Hospital Istanbul, Turkey
  More Information

No publications provided

Responsible Party: Ilhan Karacan, Clinical Associated Professor, Chief of Physical Med & Rehab Clinic, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01553344     History of Changes
Other Study ID Numbers: BEAH FTR -7
Study First Received: March 12, 2012
Last Updated: May 6, 2013
Health Authority: Turkey: Ministry of Health

Keywords provided by Bagcilar Training and Research Hospital:
sclerostin
osteomalacia

Additional relevant MeSH terms:
Endocrine System Diseases
Osteomalacia
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
 Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on May 16, 2013