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Teriparatide for Postsurgical Hypoparathyroidism

This study is currently recruiting participants.
Verified January 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Marius Stan, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01171690
First received: July 27, 2010
Last updated: January 16, 2013
Last verified: January 2013
History of Changes
  Purpose

Will teriparatide ( Forteo) 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:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Hospital length of stay [ Time Frame: At 3 months from surgery ] [ Designated as safety issue: Yes ]
    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 intravenous (IV) calcium in last 24 hours).


Secondary Outcome Measures:
  • Safety analysis [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    total adverse events, severe and serious adverse events with particular attention to episodes of hypotension

  • number of episodes of hypocalcemia [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    percent of patients that redevelop hypocalcemia off teriparatide at day 17 and 25

  • percent of patients with persistent hypoparathyroidism [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    percent of patients with persistent hypoparathyroidism at 3 months from enrollment


Estimated Enrollment: 45
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 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:

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.

  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:

  • Renal failure
  • Any prior parathyroid pathology
  • Pre-existing hypercalcemia
  • Metabolic bone diseases other than osteoporosis
  • Paget's disease
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171690

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Marius Stan, MD     507-284-2463     stan.marius@mayo.edu    
Principal Investigator: Marius N Stan, MD            
Sub-Investigator: Irina Bancos, MD            
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
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Hypoparathyroidism

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

ClinicalTrials.gov processed this record on May 21, 2013