Hypoparathyroidism PostproceduralNCT04146259
Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism
An observational study of Hypoparathyroidism Postprocedural, run by University of Athens at 1 site in Greece.
Trial summary
To investigate changes in sclerostin levels following acute post-thyroidectomy hypoparathyroidism Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Hypoparathyroidism Postprocedural
- What is being tested?
- calcium carbonate and alphacalcidol
- How many people
- 109 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2017to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with indication for total thyroidectomy
Who may be able to join
- Indication for total thyroidectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To investigate changes in sclerostin levels following acute post-thyroidectomy hypoparathyroidism
Read the 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
- Conditions
- Hypoparathyroidism Postprocedural
- Being tested
- calcium carbonate and alphacalcidol
- Keywords
- Sclerostin, Hypoparathyroidism
- Medical subject headings
- Sclerosteosis, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium carbonate and alphacalcidolDrug
treatment for hypocalcemia
| Study group | Role | What they receive |
|---|---|---|
| group A | Control | |
| Group B | Post-surgical hypoparathyroidism Receives: Drug: calcium carbonate and alphacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in circulating serum sclerostin levels (pmol/L) during the observation period
change in circulating serum sclerostin levels (pmol/L)during the observation period
Measured: 7 days
Secondary outcomes (1)
the between groups difference in % changes of circulating sclerostin
the between groups difference in % changes of circulating sclerostin
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoparathyroidism PostproceduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Symeon tournis, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146259
- Sponsor's protocol ID
- 1387/08-12-2015
- Status last verified
- Oct 2019
- First submitted
- 29 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT04146259
- Acronym / sponsor ID
- 1387/08-12-2015
- Conditions
- Hypoparathyroidism Postprocedural
- Keywords
- Sclerostin, Hypoparathyroidism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | –Control |
| Group B | – | Drug: calcium carbonate and alphacalcidolPost-surgical hypoparathyroidism |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with indication for total thyroidectomy
Key inclusion criteria (1 listed)
- Indication for total thyroidectomy
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcium carbonate and alphacalcidoltreatment for hypocalcemia | Drug | Group B |
Primary outcome
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
1 secondary outcome
the between groups difference in % changes of circulating sclerostin
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Hypoparathyroidism Postprocedural
RecruitingPhase 1/2
Parathyroid Allotransplant for Treatment of Hypoparathyroidism
Hypoparathyroidism, Hypoparathyroidism Postprocedural
Recruiting
Parathyroid Allotransplant for Severe Refractory Hypoparathyroidism
Hypoparathyroidism Postprocedural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoparathyroidism Postprocedural, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in circulating serum sclerostin levels (pmol/L) during the observation period (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.