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 20mcgof 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 subjectsand2 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. (J Clin Endocrinol Metab 101: 4039-4045, 2016).
PTH(1-34) for the Primary Prevention of Postthyroidectomy Hypocalcemia: The THYPOS Trial
Tabacco, Gaia;Briganti, Silvia Irina;
2016-01-01
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 20mcgof 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 subjectsand2 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. (J Clin Endocrinol Metab 101: 4039-4045, 2016).I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
