Teriparatide for Postsurgical Hypoparathyroidism

This study has been terminated.
(Funding problems)
Sponsor:
Information provided by (Responsible Party):
Marius Stan, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01171690
First received: July 27, 2010
Last updated: December 19, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention Phase
Hypoparathyroidism Post-surgical
Drug: Teriparatide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Hospital Length of Stay [ Time Frame: Approximately 7 days after surgery ] [ Designated as safety issue: Yes ]
    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:
  • Safety Analysis [ Time Frame: Approximately 90 days after surgery ] [ Designated as safety issue: Yes ]
    Arms were compared for total number of adverse events, including severe and serious adverse events.


Enrollment: 5
Study Start Date: November 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.
Other Name: Forteo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients post bilateral thyroid bed surgery (cancer, Graves disease, multinodular goiter)
  • Symptomatic hypocalcemia
  • Total calcium < 8 mg/dL persisting after 24 hours of therapy with calcitriol (minimum 0.25 mcg twice a day) and calcium supplementation (minimum 1.5 grams of elemental calcium per day)
  • Parathyroid hormone (PTH) level below low end of normal range

Exclusion criteria (all subjects):

  • Renal failure
  • Any prior parathyroid pathology
  • Pre-existing hypercalcemia
  • Metabolic bone diseases other than osteoporosis
  • Pagets disease

Exclusion criteria (active treatment subjects only):

  • Ongoing therapy with Forteo for osteoporosis
  • Active non-thyroidal malignancy or suspicion of residual thyroid malignancy
  • History of skeletal malignancies, primary or metastatic
  • Pregnancy
  • Active or recent urolithiasis
  • Digitalis therapy
  • Patients at increased baseline risk for osteosarcoma, i.e., family history of osteosarcoma or prior radiation therapy involving the skeleton
  • Pediatric populations
  • Unexplained elevations of alkaline phosphatase
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171690

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Marius Stan, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Marius Stan, Assistant Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01171690     History of Changes
Other Study ID Numbers: 10-000901
Study First Received: July 27, 2010
Results First Received: December 2, 2014
Last Updated: December 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Hypoparathyroidism

Additional relevant MeSH terms:
Hypoparathyroidism
Endocrine System Diseases
Parathyroid Diseases
Teriparatide
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 01, 2015