Hypoparathyroidism Post-surgical Clinical Trial
Official title:
Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism
This study evaluated the effects of teriparatide (Forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone. The hypothesis was that teriparatide ( Forteo) would shorten the length of hospitalization post thyroidectomy in patients with symptomatic hypoparathyroidism.
Transient hypoparathyroidism with hypocalcemia occurs in up to 20 % of patients after
surgery for thyroid cancer, multinodular goiter or Graves' disease and is severe in around 3
to 18% of cases. Severe hypocalcemia significantly lengthens their hospital stay. This study
will evaluate the effects of teriparatide (synthetic parathyroid hormone, brand name Forteo)
on low calcium levels in the setting of thyroid surgery associated with low parathyroid
hormone.
This was a feasibility open-label, single-arm trial with historical matched controls with a
planned enrollment of 15 patients with severe, symptomatic hypocalcemia that would be
treated with teriparatide for a maximum duration of 3 weeks and compared the active subjects
with 30 gender and age matched controls.
Therapy for hypocalcemia continued in accordance with current practice. The decision for
discharge, as far as calcium is concerned, was to be reached when calcium level was > 7.5
mg/dL and increased x 2 over 12 hours in an asymptomatic patient with stable therapy and no
need for IV calcium in the last 24 hours. Subjects were followed by phone and with blood
tests 2 days after discharge and 9, 17 and 25 days after initiation of teriparatide. They
were off teriparatide for 24 hours prior to testing on days 9, 17 and 25.
If hypocalcemia recurred after 2nd week, teriparatide was continued for a 3rd week and then
discontinued. If hypocalcemia recurred again current standard therapy for hypoparathyroidism
was continued off teriparatide.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment