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Clinical Trials/NCT04146259
NCT04146259CompletedNot Applicable

Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism

University of Athens1 site in 1 country109 target enrollmentStarted: January 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
109
Locations
1
Primary Endpoint
change in circulating serum sclerostin levels (pmol/L) during the observation period

Study Overview

Brief Summary

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

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group B

Post-surgical hypoparathyroidism

Intervention: calcium carbonate and alphacalcidol (Drug)

Outcomes

Primary Outcomes

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 Outcomes

  • the between groups difference in % changes of circulating sclerostin(7 days)

Investigators

Sponsor
University of Athens
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Symeon tournis

Senior Research Fellow

University of Athens

Study Sites (1)

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