Clinical Trial: Teriparatide for Postsurgical Hypoparathyroidism

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Mayo Clinic

Current Primary Outcome: Hospital Length of Stay [ Time Frame: Approximately 7 days after surgery ]

Hospital length of stay from initiation of therapy with calcium and calcitriol to "ready to discharge" from a calcium perspective (calcium level > 7.5 mg/dL and increasing x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for intravenous (IV) calcium in last 24 hours).


Original Primary Outcome: Hospital Length of Stay [ Time Frame: At 3 months from surgery ]

Hospital length of stay from initiation of therapy with calcium and calcitriol to "ready to discharge" from calcium perspective (calcium level > 7.5 mg/dL and increasing x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for IV calcium in last 24hours).


Current Secondary Outcome: Safety Analysis [ Time Frame: Approximately 90 days after surgery ]

Arms were compared for total number of adverse events, including severe and serious adverse events.


Original Secondary Outcome:

  • Safety Analysis [ Time Frame: 90 days ]
    total adverse events, severe and serious adverse events with particular attention to episodes of hypotension
  • number of episodes of hypocalcemia [ Time Frame: 90 days ]
    number of episodes of hypocalcemia (calcium < 8 mg/dL) after teriparatide therapy initiated
  • percent of patients able to decrease amount of calcium and vitamin D [ Time Frame: 90 days ]
    percent of patients able to decrease amount of calcium and vitamin D from baseline on teriparatide;
  • percent of patients that redevelop hypocalcemia off teriparatide [ Time Frame: 2 and 3 weeks respectively ]
    percent of patients that redevelop hypocalcemia off teriparatide at day 17 and 25
  • percent of patients with persistent hypoparathyroidism [ Time Frame: 3 months ]
    percent of patients with persistent hypoparathyroidism at 3 months from enrollment


Information By: Mayo Clinic

Dates:
Date Received: July 27, 2010
Date Started: November 2010
Date Completion:
Last Updated: December 19, 2014
Last Verified: December 2014