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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Hanna Hollman
- Telefonnummer: +37259037517
- E-post: hanna.hollman@ut.ee
Studer Kontakt Backup
- Navn: Ceith Nikkolo
- Telefonnummer: +372 53318092
Studiesteder
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Tartu, Estland
- Rekruttering
- Tartu University Hospital
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Ta kontakt med:
- Ceith Nikkolo, PhD
- Telefonnummer: +372 53319082
- E-post: ceith.nikkolo@kliinikum.ee
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Other
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Tallinn, Other, Estland, 11914
- Rekruttering
- East Tallinn Central Hospital
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Ta kontakt med:
- Hanna Hollman, MD
- Telefonnummer: + 372 59037517
- E-post: hanna.hollman@itk.ee
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Occurence of symptomatic hypoparathyroidism
Tidsramme: 2 weeks
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Occurrence of symptomatic hypoparathyroidism within 14 days postoperatively
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2 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Serum calcium levels at 2 week follow-up
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
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2 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TartuUH-ETCH_403/T-13_2
Plan for individuelle deltakerdata (IPD)
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