Changes in Circulating Sclerostin Levels During Acute Pos... | NCT04146259

Studies
Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism

NCT04146259

Sponsor

University of Athens

Status

Completed

Last Update Posted

Nov 1, 2019Actual

Enrollment

109Actual

Phase

Not provided

Conditions

Hypoparathyroidism Postprocedural

Interventions

calcium carbonate and alphacalcidol

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Aug 1, 2019Actual

First Submitted Date

Oct 29, 2019

First Submission Date that Met QC Criteria

Oct 29, 2019

First Posted Date

Oct 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2019

Last Update Posted Date

Nov 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A		Control
Group B		Post-surgical hypoparathyroidism	Drug: calcium carbonate and alphacalcidol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
calcium carbonate and alphacalcidol	Drug	treatment for hypocalcemia	Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
the between groups difference in % changes of circulating sclerostin	the between groups difference in % changes of circulating sclerostin	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Female patients with indication for total thyroidectomy

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Symeon Tournis		Athens		14561	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C537525	Sclerosteosis
D007011	Hypoparathyroidism

Ancestor Terms

ID	Term
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002119	Calcium Carbonate
C008088	alfacalcidol

Ancestor Terms

ID	Term
D017610	Calcium Compounds
D007287	Inorganic Chemicals
D002254	Carbonates
D002255	Carbonic Acid

Browse Leaves

Not provided

Browse Branches

Not provided