Teriparatide for Postsurgical Hypoparathyroidism

Phase 2

Terminated

• Conditions: Hypoparathyroidism Post-surgical
• Interventions: Drug: Teriparatide

• Registration Number: NCT01171690
• Lead Sponsor: Mayo Clinic

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 Description

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.

Study Timeline

• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Study Start: 2010-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-12
• Results First Submitted: 2014-12-02
• Results First Submitted QC: 2014-12-19
• Last Update Submitted: 2014-12-19
• Results First Posted: 2014-12-22
• Last Update Posted: 2014-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teriparatide	Teriparatide	The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.

Primary Outcome Measures

Name	Time	Method
Hospital Length of Stay	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).

Secondary Outcome Measures

Name	Time	Method
Safety Analysis	Approximately 90 days after surgery	Arms were compared for total number of adverse events, including severe and serious adverse events.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States