PTH(1-34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial

J Clin Endocrinol Metab. 2016 Nov;101(11):4039-4045. doi: 10.1210/jc.2016-2530. Epub 2016 Aug 15.

Abstract

Context: There are no studies evaluating teriparatide for prevention of post-thyroidectomy hypocalcemia.

Objective: Our objective was to evaluate whether teriparatide can prevent postsurgical hypocalcemia and shorten the hospitalization in subjects at high risk of hypocalcemia following thyroid surgery.

Design: This was a prospective phase II randomized open-label trial.

Setting: This trial was set on a surgical ward.

Patients: Twenty-six subjects (six males, 20 females) with intact PTH lower than10 pg/ml 4 hours after thyroidectomy were included.

Intervention: Subjects were randomized (1:1) to receive SC administration of 20 mcg of teriparatide every 12 hours until the discharge (treatment group) or to follow standard clinical care (control group).

Main outcome measure: Adjusted serum calcium, duration of hospitalization, and calcium/calcitriol supplementation were measured.

Results: Overall, the incidence of hypocalcemia was 3/13 in treatment group and 11/13 in the control group (P = .006). Treated patients had a lower risk of hypocalcemia than controls (relative risk, 0.26 [95% confidence interval, 0.09-0.723)]). The median duration of hospitalization was 3 days (interquartile range, 1) in control subjects and 2 days (interquartile range, 0) in treated subjects (P = .012). One month after discharge, 10/13 subjects in the treatment group had stopped calcium carbonate supplements, while only 5/13 in the control group had discontinued calcium. The ANOVA for repeated measures showed a significant difference in calcium supplements between groups at 1-month visit (P = .04) as well as a significant difference between discharge and 1-month visit in the treatment group (P for interaction time group = .04) Conclusions: Teriparatide may prevent postsurgical hypocalcemia, shorten the duration of hospitalization, and reduce the need for calcium and vitamin D supplementation after discharge in high risk subjects after thyroid surgery.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • Calcitriol / therapeutic use
  • Calcium, Dietary / therapeutic use
  • Dietary Supplements
  • Drug Administration Schedule
  • Female
  • Goiter, Nodular / surgery
  • Graves Disease / surgery
  • Hormone Replacement Therapy* / adverse effects
  • Hospitals, University
  • Humans
  • Hypocalcemia / blood
  • Hypocalcemia / epidemiology
  • Hypocalcemia / etiology
  • Hypocalcemia / prevention & control*
  • Incidence
  • Injections, Subcutaneous
  • Italy / epidemiology
  • Length of Stay
  • Male
  • Middle Aged
  • Parathyroid Hormone / blood
  • Postoperative Complications / blood
  • Postoperative Complications / epidemiology
  • Postoperative Complications / etiology
  • Postoperative Complications / prevention & control*
  • Risk
  • Teriparatide / administration & dosage
  • Teriparatide / adverse effects
  • Teriparatide / therapeutic use*
  • Thyroid Neoplasms / surgery
  • Thyroidectomy / adverse effects*

Substances

  • Calcium, Dietary
  • PTH protein, human
  • Parathyroid Hormone
  • Teriparatide
  • Calcitriol