Thyroid CancerNCT05252884
Calcium+Calcitriol Versus PTH for the Prevention of Hypocalcemia in Thyroidectomy. Randomized Clinical Trial
A study testing calcium correction according to PTH levels and routine postoperative calcium and calcitriol in people with Thyroid Cancer and Goiter, run by Centro de Excelencia en Enfermedades de Cabeza y Cuello at 2 sites in Colombia.
Trial summary
The objective of this study is to compare the frequency of post-thyroidectomy symptomatic and biochemical hypocalcaemia between the strategy of routine prophylactic calcium + calcitriol vs the administration of calcium guided by PTH values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Goiter, Thyroiditis
- What is being tested?
- calcium correction according to PTH levels and routine postoperative calcium and calcitriol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 2 sitesColombia
- Study dates
- 30 Jun 2022to 20 Dec 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total thyroidectomy who meet the following criteria: Patients over 18 years of age, Benign (goiter, thyroiditis, hyperthyroidism) or malignant (carcinoma) diagnosis, Patients who agree to participate in the study and sign the informed consent.
Who cannot join
- Patients with parathyroid surgery in conjunction with thyroidectomy, Patients with prior parathyroid disease for other causes (hyperparathyroidism primary or secondary to kidney disease, etc.), Patients with anaplastic carcinoma or lymphoma, Patients undergoing total thyroidectomy for causes other than thyroid disease such as, for example, total laryngectomy or pharyngo-laryngectomy that, due to margins or direct extension, require thyroidectomy. , Altered cognitive state that interfered or made the evaluation impossible.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Hospital Alma Mater de Antioquia
Medellín, Antioquia, 050010
Hospital Universitario San Vicente Fundacion
Medellín, Antioquia, 050010
About this study
Official title: Comparison of Routine Prophylactic Calcium + Calcitriol and Selective Use Based on PTH for the Prevention of Postoperative Hypocalcemia in Patients With Total Thyroidectomy. Randomized Clinical Trial
The objective of this study is to compare the frequency of post-thyroidectomy symptomatic and biochemical hypocalcaemia between the strategy of routine prophylactic calcium + calcitriol vs the administration of calcium guided by PTH values.
Read the detailed description
Postoperative hypocalcaemia is the most common complication that occurs in patients undergoing total thyroidectomy 1, with a frequency between 15 and 30%. 1-3 In the vast majority of cases, this complication is transitory, and only 1-3% manifest definitively. 4.5 Hypocalcemia is produced by surgical manipulation of the parathyroid glands, where their vascularization may be compromised, by stunning, or by inadvertent removal of the glands during thyroidectomy. 3,4 Other risk factors that have been associated include bilateral resection, inflammatory disease, and parathyroid reimplantation.1,6 Despite minimal manipulation during the surgical procedure, episodes of postoperative hypocalcemia continue to occur. To reduce the frequency of appearance and obtain symptomatic relief in the patient, several preventive strategies have been developed, 4,7-9 among which are the postoperative prophylactic administration of calcium + calcitriol 5,9 and the postoperative measurement of parathyroid hormone ( PTH) as a reference for oral calcium administration. 4,10 These strategies differ in the frequency of adverse events and cost. To date, these two interventions have not been directly compared in a clinical trial to determine which of them offers greater effectiveness and fewer adverse events and costs, and their use is made according to the individual preferences of the surgeon. A randomized clinical trial would offer information of high methodological quality for the standardization of conduct.
Research Question In a postoperative total thyroidectomy patient, is the calcium + calcitriol administration strategy based on postoperative PTH measurement superior to the routine prophylactic administration of calcium + calcitriol to reduce the frequency of symptomatic and postoperative biochemical hypocalcaemia?
Justification Postoperative hypocalcaemia is a condition that occurs in up to a third of postoperative total thyroidectomy patients. Hypocalcaemia worsens the clinical condition of the patient, implies prolongations of the hospital stay, readmissions and use of medications. 2,3,6 In addition to an adequate surgical technique, its prevention involves pharmacological interventions and diagnostic tests.
Among the alternatives currently used is the prophylactic administration of calcium and calcitriol for two weeks. 11 Despite being a cheap and safe strategy, it has uncomfortable side effects for the patient such as constipation, epigastric pain, metallic taste, loss of appetite and mood changes. 12,13 Due to this, several authors have proposed the measurement of calcium or PTH in the immediate postoperative period as a reference to decide the need for oral administration of calcium and calcitriol, thus avoiding unnecessary use in patients with normal values. 2,4,8,10,11 Theoretically, a measurement of PTH >10 pg/ml in the postoperative period would allow predicting patients who are at greater risk of developing hypocalcaemia than those who are not and can be discharged without taking calcium + calcitriol, but studies are very heterogeneous and difficult to compare with each other. 2.14 Recently, a meta-analysis evaluated the strategy of administration of calcium + calcitriol vs calcium measurement with advantages for the first 10, but there are few clinical trials that compare this strategy with postoperative PTH measurement. 14 Because this surgical group performs outpatient management after thyroidectomy, defining which of the two strategies offers greater effectiveness and a better profile of adverse events is of the utmost importance, as it would allow making general recommendations and adjusting current institutional protocols. On the other hand, the result of this trial would be a potential source of information to evaluate the cost-effectiveness of interventions in the future.
Aim: To compare the frequency of post-thyroidectomy symptomatic and biochemical hypocalcaemia between the strategy of routine prophylactic calcium + calcitriol vs the administration of calcium guided by PTH values.
- Conditions
- Thyroid Cancer, Goiter, Thyroiditis, Hyperthyroidism
- Being tested
- calcium correction according to PTH levels, routine postoperative calcium and calcitriol
- Keywords
- thyroidectomy, hypocalcemia, randomized clinical trial
- Medical subject headings
- Thyroid Neoplasms, Goiter, Thyroiditis, Hyperthyroidism, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium correction according to PTH levelsDiagnostic test
Also called PTH
A PTH blood test will be performed 4 hours post-thyroidectomy. If the PTH result is >15 pg/mL, the patient will be discharged without calcium intake; if PTH < 15 pg/mL, start a dose of 1200 mg Calcium carbonate every 8 hours + 0.25 mcg of calcitriol every 12 hours orally for 15 days
routine postoperative calcium and calcitriolDrug
Also called calcium carbonate, calcitriol
The patient will receive a dose of 1,200 mg Calcium carbonate every 8 hours + 0.25 mcg of calcitriol every 12 hours orally for 15 days, starting on the same day as the intervention.
| Study group | Role | What they receive |
|---|---|---|
| calcium correction according to PTH levels | Experimental | A PTH blood test will be performed 4 hours post-thyroidectomy. Receives: Diagnostic Test: calcium correction according to PTH levels |
| routine postoperative calcium and calcitriol | Active comparator | The patient will receive Calcium carbonate + calcitriol Receives: Drug: routine postoperative calcium and calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic hypocalcaemia
The presence of symptomatic hypocalcaemia in the postoperative period of thyroidectomy defined according to the scale proposed by Wilde et al. (hypoparathyroid patient questionnaire HPQ) Min value 0 Max value 60 Higher scores represent worst symptoms
Measured: 15 days
Secondary outcomes (2)
Biochemical hypocalcemia
Biochemical hypocalcemia defined as serum calcium < 8 mg/dL or PTH < 15
Measured: 48 hours and 15 days postoperatively
Adverse events of the medication
Adverse events of the medication (calcium+calcitriol) included in the scale of Wilde et al.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start30 Jun 2022
- Primary completion30 Oct 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel, multicenter stratified clinical trial with 1:1 allocation.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Excelencia en Enfermedades de Cabeza y Cuello
- Sponsor type
- University, hospital or other
- Collaborators
- IPS universitaria, Hospital San Vicente Fundación, Clinica Las Vegas- Grupo QuironSalud
- Responsible party
- Principal investigator, Alvaro Sanabria, Centro de Excelencia en Enfermedades de Cabeza y Cuello
- Investigators
- Alvaro Sanabria, MD, Principal investigator, Centro de Excelencia en Enfermedades de Cabeza y Cuello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252884
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abboud B, Sargi Z, Akkam M, Sleilaty F. Risk factors for postthyroidectomy hypocalcemia. J Am Coll Surg. 2002 Oct;195(4):456-61. doi: 10.1016/s1072-7515(02)01310-8.
PubMed 12375749Mathur A, Nagarajan N, Kahan S, Schneider EB, Zeiger MA. Association of Parathyroid Hormone Level With Postthyroidectomy Hypocalcemia: A Systematic Review. JAMA Surg. 2018 Jan 1;153(1):69-76. doi: 10.1001/jamasurg.2017.3398.
PubMed 29167863Terris DJ, Snyder S, Carneiro-Pla D, Inabnet WB 3rd, Kandil E, Orloff L, Shindo M, Tufano RP, Tuttle RM, Urken M, Yeh MW; American Thyroid Association Surgical Affairs Committee Writing Task Force. American Thyroid Association statement on outpatient thyroidectomy. Thyroid. 2013 Oct;23(10):1193-202. doi: 10.1089/thy.2013.0049. Epub 2013 Sep 14.
PubMed 23742254Dedivitis RA, Aires FT, Cernea CR. Hypoparathyroidism after thyroidectomy: prevention, assessment and management. Curr Opin Otolaryngol Head Neck Surg. 2017 Apr;25(2):142-146. doi: 10.1097/MOO.0000000000000346.
PubMed 28267706Sanabria A, Dominguez LC, Vega V, Osorio C, Duarte D. Routine postoperative administration of vitamin D and calcium after total thyroidectomy: a meta-analysis. Int J Surg. 2011;9(1):46-51. doi: 10.1016/j.ijsu.2010.08.006. Epub 2010 Sep 8.
PubMed 20804871Iglesias P, Diez JJ. Endocrine Complications of Surgical Treatment of Thyroid Cancer: An Update. Exp Clin Endocrinol Diabetes. 2017 Sep;125(8):497-505. doi: 10.1055/s-0043-106441. Epub 2017 Apr 25.
PubMed 28444664Leoncini E, Ricciardi W, Cadoni G, Arzani D, Petrelli L, Paludetti G, Brennan P, Luce D, Stucker I, Matsuo K, Talamini R, La Vecchia C, Olshan AF, Winn DM, Herrero R, Franceschi S, Castellsague X, Muscat J, Morgenstern H, Zhang ZF, Levi F, Dal Maso L, Kelsey K, McClean M, Vaughan TL, Lazarus P, Purdue MP, Hayes RB, Chen C, Schwartz SM, Shangina O, Koifman S, Ahrens W, Matos E, Lagiou P, Lissowska J, Szeszenia-Dabrowska N, Fernandez L, Menezes A, Agudo A, Daudt AW, Richiardi L, Kjaerheim K, Mates D, Betka J, Yu GP, Schantz S, Simonato L, Brenner H, Conway DI, Macfarlane TV, Thomson P, Fabianova E, Znaor A, Rudnai P, Healy C, Boffetta P, Chuang SC, Lee YC, Hashibe M, Boccia S. Adult height and head and neck cancer: a pooled analysis within the INHANCE Consortium. Eur J Epidemiol. 2014 Jan;29(1):35-48. doi: 10.1007/s10654-013-9863-2. Epub 2013 Nov 24.
PubMed 24271556Carr AA, Yen TW, Fareau GG, Cayo AK, Misustin SM, Evans DB, Wang TS. A single parathyroid hormone level obtained 4 hours after total thyroidectomy predicts the need for postoperative calcium supplementation. J Am Coll Surg. 2014 Oct;219(4):757-64. doi: 10.1016/j.jamcollsurg.2014.06.003. Epub 2014 Jun 18.
PubMed 25053220Arer IM, Kus M, Akkapulu N, Aytac HO, Yabanoglu H, Caliskan K, Tarim MA. Prophylactic oral calcium supplementation therapy to prevent early post thyroidectomy hypocalcemia and evaluation of postoperative parathyroid hormone levels to detect hypocalcemia: A prospective randomized study. Int J Surg. 2017 Feb;38:9-14. doi: 10.1016/j.ijsu.2016.12.041. Epub 2016 Dec 27.
PubMed 28039060Sanabria A, Rojas A, Arevalo J. Meta-analysis of routine calcium/vitamin D3 supplementation versus serum calcium level-based strategy to prevent postoperative hypocalcaemia after thyroidectomy. Br J Surg. 2019 Aug;106(9):1126-1137. doi: 10.1002/bjs.11216. Epub 2019 Jun 25.
PubMed 31236917Cayo AK, Yen TW, Misustin SM, Wall K, Wilson SD, Evans DB, Wang TS. Predicting the need for calcium and calcitriol supplementation after total thyroidectomy: results of a prospective, randomized study. Surgery. 2012 Dec;152(6):1059-67. doi: 10.1016/j.surg.2012.08.030. Epub 2012 Oct 13.
PubMed 23068088Harvey NC, Biver E, Kaufman JM, Bauer J, Branco J, Brandi ML, Bruyere O, Coxam V, Cruz-Jentoft A, Czerwinski E, Dimai H, Fardellone P, Landi F, Reginster JY, Dawson-Hughes B, Kanis JA, Rizzoli R, Cooper C. The role of calcium supplementation in healthy musculoskeletal ageing : An expert consensus meeting of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the International Foundation for Osteoporosis (IOF). Osteoporos Int. 2017 Feb;28(2):447-462. doi: 10.1007/s00198-016-3773-6. Epub 2016 Oct 20.
PubMed 27761590Sanaei M, Banasiri M, Shafiee G, Rostami M, Alizad S, Ebrahimi M, Larijani B, Heshmat R. Calcium vitamin D3 supplementation in clinical practice: side effect and satisfaction. J Diabetes Metab Disord. 2016 Mar 29;15:9. doi: 10.1186/s40200-016-0231-0. eCollection 2015.
PubMed 27030820Houlton JJ, Pechter W, Steward DL. PACU PTH facilitates safe outpatient total thyroidectomy. Otolaryngol Head Neck Surg. 2011 Jan;144(1):43-7. doi: 10.1177/0194599810390453.
PubMed 21493385Garcia-Lozano C, Betancourt C, Sanchez JG, Pinillos P, Trujillo Y, Marulanda M, Olivera MP, Ariza A, Figueroa-Bohorquez D, Mendieta L, Santivanez JJ, Sanabria A. Routine vs Selective Calcium Supplementation After Total Thyroidectomy: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Apr 1;152(4):392-399. doi: 10.1001/jamaoto.2025.5514.
PubMed 41712216
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Routine Prophylactic Calcium + Calcitriol and Selective Use Based on PTH for the Prevention of Postoperative Hypocalcemia in Patients With Total Thyroidectomy. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05252884
- Acronym / sponsor ID
- 1
- Conditions
- Thyroid Cancer, Goiter, Thyroiditis, Hyperthyroidism
- Keywords
- thyroidectomy, hypocalcemia, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Centro de Excelencia en Enfermedades de Cabeza y CuelloUniversity, hospital or other
- Collaborators
- IPS universitaria, Hospital San Vicente Fundación, Clinica Las Vegas- Grupo QuironSalud
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 23 Feb 2022 (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.
The objective of this study is to compare the frequency of post-thyroidectomy symptomatic and biochemical hypocalcaemia between the strategy of routine prophylactic calcium + calcitriol vs the administration of calcium guided by PTH values.
Detailed description
Postoperative hypocalcaemia is the most common complication that occurs in patients undergoing total thyroidectomy 1, with a frequency between 15 and 30%. 1-3 In the vast majority of cases, this complication is transitory, and only 1-3% manifest definitively. 4.5 Hypocalcemia is produced by surgical manipulation of the parathyroid glands, where their vascularization may be compromised, by stunning, or by inadvertent removal of the glands during thyroidectomy. 3,4 Other risk factors that have been associated include bilateral resection, inflammatory disease, and parathyroid reimplantation.1,6 Despite minimal manipulation during the surgical procedure, episodes of postoperative hypocalcemia continue to occur. To reduce the frequency of appearance and obtain symptomatic relief in the patient, several preventive strategies have been developed, 4,7-9 among which are the postoperative prophylactic administration of calcium + calcitriol 5,9 and the postoperative measurement of parathyroid hormone ( PTH) as a reference for oral calcium administration. 4,10 These strategies differ in the frequency of adverse events and cost. To date, these two interventions have not been directly compared in a clinical trial to determine which of them offers greater effectiveness and fewer adverse events and costs, and their use is made according to the individual preferences of the surgeon. A randomized clinical trial would offer information of high methodological quality for the standardization of conduct.
Research Question In a postoperative total thyroidectomy patient, is the calcium + calcitriol administration strategy based on postoperative PTH measurement superior to the routine prophylactic administration of calcium + calcitriol to reduce the frequency of symptomatic and postoperative biochemical hypocalcaemia?
Justification Postoperative hypocalcaemia is a condition that occurs in up to a third of postoperative total thyroidectomy patients. Hypocalcaemia worsens the clinical condition of the patient, implies prolongations of the hospital stay, readmissions and use of medications. 2,3,6 In addition to an adequate surgical technique, its prevention involves pharmacological interventions and diagnostic tests.
Among the alternatives currently used is the prophylactic administration of calcium and calcitriol for two weeks. 11 Despite being a cheap and safe strategy, it has uncomfortable side effects for the patient such as constipation, epigastric pain, metallic taste, loss of appetite and mood changes. 12,13 Due to this, several authors have proposed the measurement of calcium or PTH in the immediate postoperative period as a reference to decide the need for oral administration of calcium and calcitriol, thus avoiding unnecessary use in patients with normal values. 2,4,8,10,11 Theoretically, a measurement of PTH >10 pg/ml in the postoperative period would allow predicting patients who are at greater risk of developing hypocalcaemia than those who are not and can be discharged without taking calcium + calcitriol, but studies are very heterogeneous and difficult to compare with each other. 2.14 Recently, a meta-analysis evaluated the strategy of administration of calcium + calcitriol vs calcium measurement with advantages for the first 10, but there are few clinical trials that compare this strategy with postoperative PTH measurement. 14 Because this surgical group performs outpatient management after thyroidectomy, defining which of the two strategies offers greater effectiveness and a better profile of adverse events is of the utmost importance, as it would allow making general recommendations and adjusting current institutional protocols. On the other hand, the result of this trial would be a potential source of information to evaluate the cost-effectiveness of interventions in the future.
Aim: To compare the frequency of post-thyroidectomy symptomatic and biochemical hypocalcaemia between the strategy of routine prophylactic calcium + calcitriol vs the administration of calcium guided by PTH values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized, parallel, multicenter stratified clinical trial with 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| calcium correction according to PTH levels | Experimental | Diagnostic Test: calcium correction according to PTH levelsA PTH blood test will be performed 4 hours post-thyroidectomy. |
| routine postoperative calcium and calcitriol | Active comparator | Drug: routine postoperative calcium and calcitriolThe patient will receive Calcium carbonate + calcitriol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing total thyroidectomy who meet the following criteria: Patients over 18 years of age, Benign (goiter, thyroiditis, hyperthyroidism) or malignant (carcinoma) diagnosis, Patients who agree to participate in the study and sign the informed consent.
Key exclusion criteria (1 listed)
- Patients with parathyroid surgery in conjunction with thyroidectomy, Patients with prior parathyroid disease for other causes (hyperparathyroidism primary or secondary to kidney disease, etc.), Patients with anaplastic carcinoma or lymphoma, Patients undergoing total thyroidectomy for causes other than thyroid disease such as, for example, total laryngectomy or pharyngo-laryngectomy that, due to margins or direct extension, require thyroidectomy. , Altered cognitive state that interfered or made the evaluation impossible.
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 correction according to PTH levelsAlso: PTHA PTH blood test will be performed 4 hours post-thyroidectomy. If the PTH result is >15 pg/mL, the patient will be discharged without calcium intake; if PTH < 15 pg/mL, start a dose of 1200 mg Calcium carbonate every 8 hours + 0.25 mcg of calcitriol every 12 hours orally for 15 days | Diagnostic test | calcium correction according to PTH levels |
| routine postoperative calcium and calcitriolAlso: calcium carbonate, calcitriolThe patient will receive a dose of 1,200 mg Calcium carbonate every 8 hours + 0.25 mcg of calcitriol every 12 hours orally for 15 days, starting on the same day as the intervention. | Drug | routine postoperative calcium and calcitriol |
Primary outcome
symptomatic hypocalcaemia
Time frame: 15 days
The presence of symptomatic hypocalcaemia in the postoperative period of thyroidectomy defined according to the scale proposed by Wilde et al. (hypoparathyroid patient questionnaire HPQ) Min value 0 Max value 60 Higher scores represent worst symptoms
2 secondary outcomes
Biochemical hypocalcemia
Time frame: 48 hours and 15 days postoperatively
Adverse events of the medication
Time frame: 15 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 7 Feb 2025.
- Background: PubMed 12375749Abboud B, Sargi Z, Akkam M, Sleilaty F. Risk factors for postthyroidectomy hypocalcemia. J Am Coll Surg. 2002 Oct;195(4):456-61. doi: 10.1016/s1072-7515(02)01310-8.
- Background: PubMed 29167863Mathur A, Nagarajan N, Kahan S, Schneider EB, Zeiger MA. Association of Parathyroid Hormone Level With Postthyroidectomy Hypocalcemia: A Systematic Review. JAMA Surg. 2018 Jan 1;153(1):69-76. doi: 10.1001/jamasurg.2017.3398.
- Background: PubMed 23742254Terris DJ, Snyder S, Carneiro-Pla D, Inabnet WB 3rd, Kandil E, Orloff L, Shindo M, Tufano RP, Tuttle RM, Urken M, Yeh MW; American Thyroid Association Surgical Affairs Committee Writing Task Force. American Thyroid Association statement on outpatient thyroidectomy. Thyroid. 2013 Oct;23(10):1193-202. doi: 10.1089/thy.2013.0049. Epub 2013 Sep 14.
- Background: PubMed 28267706Dedivitis RA, Aires FT, Cernea CR. Hypoparathyroidism after thyroidectomy: prevention, assessment and management. Curr Opin Otolaryngol Head Neck Surg. 2017 Apr;25(2):142-146. doi: 10.1097/MOO.0000000000000346.
- Background: PubMed 20804871Sanabria A, Dominguez LC, Vega V, Osorio C, Duarte D. Routine postoperative administration of vitamin D and calcium after total thyroidectomy: a meta-analysis. Int J Surg. 2011;9(1):46-51. doi: 10.1016/j.ijsu.2010.08.006. Epub 2010 Sep 8.
- Background: PubMed 28444664Iglesias P, Diez JJ. Endocrine Complications of Surgical Treatment of Thyroid Cancer: An Update. Exp Clin Endocrinol Diabetes. 2017 Sep;125(8):497-505. doi: 10.1055/s-0043-106441. Epub 2017 Apr 25.
- Background: PubMed 24271556Leoncini E, Ricciardi W, Cadoni G, Arzani D, Petrelli L, Paludetti G, Brennan P, Luce D, Stucker I, Matsuo K, Talamini R, La Vecchia C, Olshan AF, Winn DM, Herrero R, Franceschi S, Castellsague X, Muscat J, Morgenstern H, Zhang ZF, Levi F, Dal Maso L, Kelsey K, McClean M, Vaughan TL, Lazarus P, Purdue MP, Hayes RB, Chen C, Schwartz SM, Shangina O, Koifman S, Ahrens W, Matos E, Lagiou P, Lissowska J, Szeszenia-Dabrowska N, Fernandez L, Menezes A, Agudo A, Daudt AW, Richiardi L, Kjaerheim K, Mates D, Betka J, Yu GP, Schantz S, Simonato L, Brenner H, Conway DI, Macfarlane TV, Thomson P, Fabianova E, Znaor A, Rudnai P, Healy C, Boffetta P, Chuang SC, Lee YC, Hashibe M, Boccia S. Adult height and head and neck cancer: a pooled analysis within the INHANCE Consortium. Eur J Epidemiol. 2014 Jan;29(1):35-48. doi: 10.1007/s10654-013-9863-2. Epub 2013 Nov 24.
- Background: PubMed 25053220Carr AA, Yen TW, Fareau GG, Cayo AK, Misustin SM, Evans DB, Wang TS. A single parathyroid hormone level obtained 4 hours after total thyroidectomy predicts the need for postoperative calcium supplementation. J Am Coll Surg. 2014 Oct;219(4):757-64. doi: 10.1016/j.jamcollsurg.2014.06.003. Epub 2014 Jun 18.
- Background: PubMed 28039060Arer IM, Kus M, Akkapulu N, Aytac HO, Yabanoglu H, Caliskan K, Tarim MA. Prophylactic oral calcium supplementation therapy to prevent early post thyroidectomy hypocalcemia and evaluation of postoperative parathyroid hormone levels to detect hypocalcemia: A prospective randomized study. Int J Surg. 2017 Feb;38:9-14. doi: 10.1016/j.ijsu.2016.12.041. Epub 2016 Dec 27.
- Background: PubMed 31236917Sanabria A, Rojas A, Arevalo J. Meta-analysis of routine calcium/vitamin D3 supplementation versus serum calcium level-based strategy to prevent postoperative hypocalcaemia after thyroidectomy. Br J Surg. 2019 Aug;106(9):1126-1137. doi: 10.1002/bjs.11216. Epub 2019 Jun 25.
- Background: PubMed 23068088Cayo AK, Yen TW, Misustin SM, Wall K, Wilson SD, Evans DB, Wang TS. Predicting the need for calcium and calcitriol supplementation after total thyroidectomy: results of a prospective, randomized study. Surgery. 2012 Dec;152(6):1059-67. doi: 10.1016/j.surg.2012.08.030. Epub 2012 Oct 13.
- Background: PubMed 27761590Harvey NC, Biver E, Kaufman JM, Bauer J, Branco J, Brandi ML, Bruyere O, Coxam V, Cruz-Jentoft A, Czerwinski E, Dimai H, Fardellone P, Landi F, Reginster JY, Dawson-Hughes B, Kanis JA, Rizzoli R, Cooper C. The role of calcium supplementation in healthy musculoskeletal ageing : An expert consensus meeting of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the International Foundation for Osteoporosis (IOF). Osteoporos Int. 2017 Feb;28(2):447-462. doi: 10.1007/s00198-016-3773-6. Epub 2016 Oct 20.
- Individual participant dataSharing planned: No
Related trials for Thyroid Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
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.
Alvaro Sanabria, MD principal investigator
Centro de Excelencia en Enfermedades de Cabeza y Cuello
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcium correction according to PTH levels and routine postoperative calcium and calcitriol in people with Thyroid Cancer and Goiter, run by Centro de Excelencia en Enfermedades de Cabeza y Cuello at 2 sites in Colombia.
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 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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?
symptomatic hypocalcaemia (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05252884, which also lists 15 linked publications.
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 7 Feb 2025.