SE OF TERIPARATIDE TO PREVENT HYPOCALCEMIA IN POST SURGICAL PATIENTS

Phase 1

• Conditions: POST SURGICAL HYPOCALCEMIA; MedDRA version: 20.0Level: PTClassification code 10033557Term: PalpitationsSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10021097Term: HypotensionSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.0Level: PTClassification code 10037087Term: PruritusSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2016-000481-32-IT
• Lead Sponsor: IVERSITÀ CAMPUS BIO-MEDICO DI ROMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

surgical indication for thyroidectomy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Age younger than 18 years
-Pregnancy
-Renal failure (glomerular filtration rate < 30 mL/min)
-Hypersensitivity to the active substance or excipients
-Any prior parathyroid pathology
-Familiar history of Osteosarcoma or any other bone tumors
-Preexisting hypercalcemia
-Symptomatic orthostatic hypotension
-Metabolic bone disease other than osteoporosis
-Ongoing teriparatide therapy for osteoporosis
-History of skeletal malignancies (primary or metastatic)
-Treatment with digoxin (digitalis therapy)
-Active or recent urolithiasis
-Unexplained elevation of serum alkaline phosphatase levels
-Prior radiation therapy involving the skeleton

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate if teriparatide is able to prevent post-surgical hypocalcemia in subjects with high risk of hypocalcemia after thyroid surgery. ;Secondary Objective: N.A.;Primary end point(s): Change in calcium levels from the enrollment to the discharge;Timepoint(s) of evaluation of this end point: every 12 hours till to discharge

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): reduction of duration of the hospitalization;Timepoint(s) of evaluation of this end point: at the discharge