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

PTH(1-34) for the primary prevention of post-surgical hypocalcemia: the THYPOS trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74486450
Enrollment
22
Registered
2016-04-12
Start date
2016-02-01
Completion date
Unknown
Last updated
2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 clin

Sponsors

Università Campus Bio-Medico di Roma
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 and over 2. Patients with a formal surgical indication for thyroidectomy.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026