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Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism

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ClinicalTrials.gov Identifier: NCT04146259
Recruitment Status : Completed
First Posted : October 31, 2019
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
Symeon tournis, University of Athens

Brief Summary:
To investigate changes in sclerostin levels following acute post-thyroidectomy hypoparathyroidism

Condition or disease Intervention/treatment
Hypoparathyroidism Postprocedural Drug: calcium carbonate and alphacalcidol

Detailed Description:

Female patients with thyroid disorders, referred to the Department of Head and Neck Surgery, at Metaxa Anti-Cancer Hospital of Piraeus, for total thyroidectomy.

Based on the development of biochemical hypocalcemia (cCa < 8.4 mg/dl), subjects were divided into 2 groups: Group A: without postsurgical hypoparathyroidism that served as controls and group B: subjects, with acute postsurgical hypoparathyroidism.

Blood collections were performed in the morning after an overnight fast, in at least 3 different time points; preoperatively, 1st postoperative day and 7th postoperative day for the detrmination of sclerostin levels

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Study Type : Observational
Actual Enrollment : 109 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
group A
Control
Group B
Post-surgical hypoparathyroidism
Drug: calcium carbonate and alphacalcidol
treatment for hypocalcemia




Primary Outcome Measures :
  1. change in circulating serum sclerostin levels (pmol/L) during the observation period [ Time Frame: 7 days ]
    change in circulating serum sclerostin levels (pmol/L)during the observation period


Secondary Outcome Measures :
  1. the between groups difference in % changes of circulating sclerostin [ Time Frame: 7 days ]
    the between groups difference in % changes of circulating sclerostin


Biospecimen Retention:   Samples Without DNA
blood samples


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients with indication for total thyroidectomy
Criteria

Inclusion Criteria:

  • Indication for total thyroidectomy

Exclusion Criteria:

  • parathyroid disorders, chronic kidney disease (eGFR< 60 ml/min), treatment with antiosteoporosis drugs, rheumatic disease and history of long term (>1 month) or current corticosteroid use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146259


Locations
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Greece
Symeon Tournis
Athens, Greece, 14561
Sponsors and Collaborators
University of Athens
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Responsible Party: Symeon tournis, Senior Research Fellow, University of Athens
ClinicalTrials.gov Identifier: NCT04146259    
Other Study ID Numbers: 1387/08-12-2015
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Symeon tournis, University of Athens:
Sclerostin
Hypoparathyroidism
Additional relevant MeSH terms:
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Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Alfacalcidol
Hydroxycholecalciferols
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Bone Density Conservation Agents
Vitamins
Micronutrients