Can Teriparatide prevent the onset of hypocalcemia after surgical thyroid removal?

• Register: ISRCTN
• Last refreshed on: 5 June 2017
• Main ID: ISRCTN74486450
• Date of registration: 12/04/2016
• Prospective Registration: No
• Primary sponsor: Università Campus Bio-Medico di Roma
• Public title: Can Teriparatide prevent the onset of hypocalcemia after surgical thyroid removal?
• Scientific title: PTH(1-34) for the primary prevention of post-surgical hypocalcemia: the THYPOS trial
• Date of first enrolment: 01/02/2016
• Target sample size: 22
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN74486450
• Study type: Interventional
• Study design: Prospective phase II single-centre open label randomized controlled trial (Prevention)
• Phase: Phase II

Countries of recruitment

Italy

Contacts

• Name: Andrea Palermo

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18 and over
2. Patients with a formal surgical indication for thyroidectomy.
Exclusion criteria: 1. Aged under 18 years
2. Pregnancy
3. Renal failure (glomerular filtration rate < 30 mL/min)
4. Hypersensitivity to the active substance or excipients
5. Any prior parathyroid pathology
6. Preexisting hypercalcemia
7. Metabolic bone disease other than osteoporosis
8. Ongoing therapy for osteoporosis
9. In the last 6 months administration of calcitonin
10. Systemic corticosteroids, estrogens, raloxifene, fluoride, lithium, loop or thiazide diuretics, aromatase inhibitors or other drugs that could interfere with calcium metabolism
11. History of skeletal malignancies (primary or metastatic)
12. Active or recent urolithiasis
13. Unexplained elevation of serum alkaline phosphatase levels
14. Prior radiation therapy involving the skeleton, serum magnesium levels below the lower limits or above the upper limits of normal

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Hypocalcemia due to Post-surgical hypoparathyroidism
Nutritional, Metabolic, Endocrine
Hypocalcemia due to Post-surgical hypoparathyroidism

Intervention(s)

Subjects with iPTH levels at 4 hours after thyroidectomy < 10 pg/ml will be enrolled. After surgery, they will be randomized (1:1) to receive treatment with teriparatide or following the standard clinical care.

Treatment group: A nurse administers 20 mcg of teriparatide using an injection pen (Forsteo® Eli Lilly Nederland B.V.) to patients immediately after randomisation. Following this, administrations will be done every 12 hours until discharge.

Control group: Participants will receive no treatment and they will be accurately observed until the discharge as suggested by national and international guidelines.

At 8.00 AM on the first and second postoperative, in fasting state, a blood sample will be drawn and calcium, phosphate, albumin, magnesium, will be measured. A clinical evaluation and ECG will be performed to exclude signs or symptoms of hypocalcemia.

Primary Outcome(s)

1. Serum calcium is measured using hematological testing at baseline (4 hours after thyroidectomy), in the morning (from 8:00 to 8:30 AM) of postoperative day 1 and 2, and daily until the discharge (if hospitalisation lasts more than two days)
2. Signs and symptoms of hypocalcemia are determined through physical examinations at baseline (4 hours after thyroidectomy) and daily until discharge.

Secondary Outcome(s)

Duration of hospitalization is measured counting the days from the thyroidectomy until the discharge.

Secondary ID(s)

N/A

2016-000481-32

Source(s) of Monetary Support

Università Campus Bio-Medico di Roma