NCT04146259

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

October 29, 2019

Last Update Submit

October 30, 2019

Conditions

Hypoparathyroidism Postprocedural

Keywords

SclerostinHypoparathyroidism

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • the between groups difference in % changes of circulating sclerostin

    7 days

Study Arms (2)

group A

Control

Group B

Post-surgical hypoparathyroidism

Drug: calcium carbonate and alphacalcidol

Interventions

calcium carbonate and alphacalcidolDRUG

treatment for hypocalcemia

Group B

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients with indication for total thyroidectomy

You may qualify if:

  • Indication for total thyroidectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Symeon Tournis

Athens, 14561, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

SclerosteosisHypoparathyroidism

Interventions

Calcium Carbonatealfacalcidol

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

October 29, 2019

First Posted

October 31, 2019

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

August 1, 2019

Last Updated

November 1, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)