Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism

Hypoparathyroidism Postprocedural Clinical Trial

Official title:

Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146259
• Other study ID #: 1387/08-12-2015
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2019
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 1, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoparathyroidism
• Hypoparathyroidism Postprocedural

Intervention

Drug:
• calcium carbonate and alphacalcidol
treatment for hypocalcemia

Locations

Country	Name	City	State
Greece	Symeon Tournis	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in circulating serum sclerostin levels (pmol/L) during the observation period	change in circulating serum sclerostin levels (pmol/L)during the observation period	7 days
Secondary	the between groups difference in % changes of circulating sclerostin	the between groups difference in % changes of circulating sclerostin	7 days