NCT03425747

Brief Summary

Hypoparathyroidism is an endocrinopathy characterized by a deficient secretion or action of PTH associated with low calcium level. According to the European guideline (2015), standard treatment includes oral calcium salts and active vitamin D metabolites to relieve symptoms of hypocalcaemia, maintain serum calcium levels in the low normal range and improve the patient's QoL Calcium carbonate is most often used and less expensive than other calcium preparations and contains the highest concentration of elemental calcium per gram (42%). It requires gastric hydrochloric acid to form carbonic acid (H2CO3) that immediately decomposes into water (H2O) and carbon dioxide (CO2). CO2 is responsible for its side effects such as flatulence, constipation and general gastrointestinal disorders. Therefore, in some patients it is better to find an alternative to calcium carbonate. Calcium citrate should be recommended to patients with achlorhydria or on treatment with proton pump inhibitors (PPI) as well as to patients who preferred to take supplements outside mealtimes. furthermore, patients with hypoparathyroidism have an increased risk of kidney stones. Kidney stones are formed by calcium salts, among which the most frequent ones are calcium-oxalate (70-80%), followed by calcium-phosphate and uric acid. Citrate salts are widely used in the treatmentof nephrolithiasis, since have shown an inhibitory effect on kidney stone formation. Up to now, there are no studies aimed to investigate the efficacy of calcium citrate in the management of subjects with chronic hypoparathyroidism. In particular, we will investigate if calcium citrate compared to calcium carbonate does not affect the risk of renal stones, if it is able to maintain normal calcium levels and, if it has an impact on QOL, in subjects with chronic hypoparathyroidism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2019

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

January 27, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
1.7 years until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

January 27, 2018

Last Update Submit

April 2, 2020

Conditions

Chronic Hypoparathyroidism

Keywords

calcium carbonatecalcium citratequality of lifehypoparathyroidismhypocalcemiacalicum oxalate saturationkydney stone

Outcome Measures

Primary Outcomes (2)

  • Change in serum calcium level

    albumin-adjusted calcium levels

    0, 1 and 2 months

  • Change in calcium oxalate saturation

    24-h urinary calcium oxalate saturation

    0, 1 and 2 months

Secondary Outcomes (1)

  • Change in Quality of life and fatigue

    0,1,2 months

Study Arms (2)

Calcium Carbonate

ACTIVE COMPARATOR

Calcium Carbonate

Drug: Calcium CarbonateDrug: Calcium Citrate

calcium Citrate

ACTIVE COMPARATOR

Calcium Citrate

Drug: Calcium CarbonateDrug: Calcium Citrate

Interventions

Calcium CarbonateDRUG

subjects will be assigned to a calcium supplement (Carbonate or Citrate) at the same total amount of elemental calcium that they had taken before the study enrolment.

Calcium Carbonatecalcium Citrate
Calcium CitrateDRUG

subjects will be assigned to a calcium supplement (Carbonate or Citrate) at the same total amount of elemental calcium that they had taken before the study enrolment.

Calcium Carbonatecalcium Citrate

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of postsurgical chronic hypoparathyroidism by at least 6 months
  • No change of treatment over the last 3 months prior to enrollment.
  • Values of serum calcium and phosphorus stable over the last three months prior to enrollment
  • Absence of symptoms from hypocalcaemia in the 3 months prior to enrollment
  • A requirement for active vitamin D (calcitriol ≥0.25 mcg daily) and oral calcium (≥1000 mg daily) treatment.

You may not qualify if:

  • liver failure
  • renal failure (gfr \<30 ml/min)
  • hypercalcemia
  • hyperthyroidism
  • parathyroid disorders
  • use of the following drugs within 3 months of the study: diuretics, bisphosphonates, calcitonin, corticosteroids, anabolic steroids, anticonvulsants, H2 receptor antagonists or proton pump inhibitor
  • heavy smokers (\>10 cigarettes/day)
  • abusing alcohol (\>70 ml/day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Bio-Medico University

Roma, 00128, Italy

Location

Related Publications (11)

  • Cusano NE, Rubin MR, Bilezikian JP. Parathyroid hormone therapy for hypoparathyroidism. Best Pract Res Clin Endocrinol Metab. 2015 Jan;29(1):47-55. doi: 10.1016/j.beem.2014.09.001. Epub 2014 Sep 10.

    PMID: 25617172BACKGROUND

  • Shoback D. Clinical practice. Hypoparathyroidism. N Engl J Med. 2008 Jul 24;359(4):391-403. doi: 10.1056/NEJMcp0803050. No abstract available.

    PMID: 18650515BACKGROUND

  • Bollerslev J, Rejnmark L, Marcocci C, Shoback DM, Sitges-Serra A, van Biesen W, Dekkers OM; European Society of Endocrinology. European Society of Endocrinology Clinical Guideline: Treatment of chronic hypoparathyroidism in adults. Eur J Endocrinol. 2015 Aug;173(2):G1-20. doi: 10.1530/EJE-15-0628.

    PMID: 26160136BACKGROUND

  • Cusano NE, Rubin MR, McMahon DJ, Irani D, Tulley A, Sliney J Jr, Bilezikian JP. The effect of PTH(1-84) on quality of life in hypoparathyroidism. J Clin Endocrinol Metab. 2013 Jun;98(6):2356-61. doi: 10.1210/jc.2013-1239. Epub 2013 Apr 17.

    PMID: 23596139BACKGROUND

  • Arlt W, Fremerey C, Callies F, Reincke M, Schneider P, Timmermann W, Allolio B. Well-being, mood and calcium homeostasis in patients with hypoparathyroidism receiving standard treatment with calcium and vitamin D. Eur J Endocrinol. 2002 Feb;146(2):215-22. doi: 10.1530/eje.0.1460215.

    PMID: 11834431BACKGROUND

  • Bilezikian JP, Khan A, Potts JT Jr, Brandi ML, Clarke BL, Shoback D, Juppner H, D'Amour P, Fox J, Rejnmark L, Mosekilde L, Rubin MR, Dempster D, Gafni R, Collins MT, Sliney J, Sanders J. Hypoparathyroidism in the adult: epidemiology, diagnosis, pathophysiology, target-organ involvement, treatment, and challenges for future research. J Bone Miner Res. 2011 Oct;26(10):2317-37. doi: 10.1002/jbmr.483.

    PMID: 21812031BACKGROUND

  • Harvey JA, Zobitz MM, Pak CY. Dose dependency of calcium absorption: a comparison of calcium carbonate and calcium citrate. J Bone Miner Res. 1988 Jun;3(3):253-8. doi: 10.1002/jbmr.5650030303.

    PMID: 3213620BACKGROUND

  • Straub DA. Calcium supplementation in clinical practice: a review of forms, doses, and indications. Nutr Clin Pract. 2007 Jun;22(3):286-96. doi: 10.1177/0115426507022003286.

    PMID: 17507729BACKGROUND

  • Tondapu P, Provost D, Adams-Huet B, Sims T, Chang C, Sakhaee K. Comparison of the absorption of calcium carbonate and calcium citrate after Roux-en-Y gastric bypass. Obes Surg. 2009 Sep;19(9):1256-61. doi: 10.1007/s11695-009-9850-6. Epub 2009 May 13.

    PMID: 19437082BACKGROUND

  • Santonati A, Palermo A, Maddaloni E, Bosco D, Spada A, Grimaldi F, Raggiunti B, Volpe R, Manfrini S, Vescini F; Hypoparathyroidism AME Group. PTH(1-34) for Surgical Hypoparathyroidism: A Prospective, Open-Label Investigation of Efficacy and Quality of Life. J Clin Endocrinol Metab. 2015 Sep;100(9):3590-7. doi: 10.1210/jc.2015-1855. Epub 2015 Jul 21.

    PMID: 26196949BACKGROUND

  • Cusano NE, Rubin MR, McMahon DJ, Irani D, Anderson L, Levy E, Bilezikian JP. PTH(1-84) is associated with improved quality of life in hypoparathyroidism through 5 years of therapy. J Clin Endocrinol Metab. 2014 Oct;99(10):3694-9. doi: 10.1210/jc.2014-2267. Epub 2014 Jun 30.

    PMID: 24978675BACKGROUND

MeSH Terms

Conditions

HypoparathyroidismHypocalcemia

Interventions

Calcium CarbonateCalcium Citrate

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Calcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMineralsCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2018

First Posted

February 8, 2018

Study Start

October 15, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

April 3, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)