- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171690
Teriparatide for Postsurgical Hypoparathyroidism
Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Length of Stay
Time Frame: Approximately 7 days after surgery
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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).
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Approximately 7 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Analysis
Time Frame: Approximately 90 days after surgery
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Arms were compared for total number of adverse events, including severe and serious adverse events.
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Approximately 90 days after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marius Stan, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-000901
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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