Calcium Replacement Therapy in Postoperative Hypoparathyroidism
A Pilot Study of Calcium Replacement Therapy in Postoperative Hypoparathyroidism
The goal of this clinical trial is to evaluate whether a lower-dose calcium replacement therapy is non-inferior to a higher-dose regimen in preventing symptomatic hypoparathyroidism in patients following thyroidectomy. The hypothesis is:
• lower-dose calcium replacement therapy is non-inferior to higher-dose therapy in preventing symptomatic hypoparathyroidism during the first two postoperative weeks
Researchers will compare patients receiving a lower-dose calcium replacement regimen with those receiving a higher-dose regimen to assess whether the lower dose is not associated with a higher incidence of symptomatic hypoparathyroidism.
Patients who develop post-thyroidectomy hypoparathyroidism are divided into groups for calcium replacement therapy. If they are asymptomatic, they will be scheduled for a follow-up visit at two weeks after surgery. During the follow-up visit, calcium metabolism will be evaluated, and treatment adjusted if necessary.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Hanna Hollman
- Telefonnummer: +37259037517
- E-post: hanna.hollman@ut.ee
Studera Kontakt Backup
- Namn: Ceith Nikkolo
- Telefonnummer: +372 53318092
Studieorter
-
-
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Tartu, Estland
- Rekrytering
- Tartu University Hospital
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Kontakt:
- Ceith Nikkolo, PhD
- Telefonnummer: +372 53319082
- E-post: ceith.nikkolo@kliinikum.ee
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-
Other
-
Tallinn, Other, Estland, 11914
- Rekrytering
- East Tallinn Central Hospital
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Kontakt:
- Hanna Hollman, MD
- Telefonnummer: + 372 59037517
- E-post: hanna.hollman@itk.ee
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- patients over the age of 18 undergoing surgery involving both lobes of the thyroid gland (thyroidectomy, "near-total" thyroidectomy, subtotal thyroidectomy, and "completed" thyroidectomy)
- Based on the first post-operative day analysis, PTH levels are below the normal range (in our hospitals 1.8-7.8 pmol/l), but not so low (below 1.06 pmol/L) as to require calcium replacement therapy with calcitriol (rocaltrol)
Exclusion Criteria:
- previously diagnosed osteoporosis; the patient is already taking calcium and vitamin D supplements prior to thyroid surgery
- renal insufficiency (eGFR < 30)
- patients with concomitant hyperparathyroidism undergoing simultaneous thyroidectomy and parathyroidectomy for a parathyroid adenoma
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Lower dose calcium replacement
calcium carbonate 1250 mg x 2
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One study group takes calcium carbonate 1250 mg (500 mg elemental calcium) twice a day (at lunchtime and in the evening)
|
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Aktiv komparator: Higher dose calcium replacement
calcium carbonate 1250 mg x 4
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The second study group takes 1250 mg of calcium carbonate (500 mg of elemental calcium) four times a day (starting at noon, at approximately 4-hour intervals: at noon, in the early afternoon, in the evening, and before bedtime).
This dosage regimen is prescribed because 500 mg of calcium can be absorbed at a time.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Occurence of symptomatic hypoparathyroidism
Tidsram: 2 weeks
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Occurrence of symptomatic hypoparathyroidism within 14 days postoperatively
|
2 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Serum calcium levels at 2 week follow-up
Tidsram: 2 weeks
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Comparison of serum calcium levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups.
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2 weeks
|
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Duration and permanence of hypoparathyroidism
Tidsram: Up to 12 months postoperatively
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Assessment of whether postoperative hypoparathyroidism resolves (transient) or persists (permanent) during follow-up.
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Up to 12 months postoperatively
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Serum parathyroid hormone (PTH) levels at 2 week follow-up
Tidsram: 2 weeks
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Comparison of serum parathyroid hormone (PTH) levels at the 2-week follow-up between lower- and higher-dose calcium replacement groups.
|
2 weeks
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TartuUH-ETCH_403/T-13_2
Plan för individuella deltagardata (IPD)
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