Skip to main content
Clinical Trials/NCT01171690
NCT01171690TerminatedPhase 2

Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism

Mayo Clinic1 site in 1 country5 target enrollmentStarted: November 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
5
Locations
1
Primary Endpoint
Hospital Length of Stay

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Teriparatide

Experimental

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.

Intervention: Teriparatide (Drug)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Safety Analysis(Approximately 90 days after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marius Stan

Assistant Professor of Medicine

Mayo Clinic

Study Sites (1)

Loading locations...

Similar Trials