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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01171690 |
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Date of registration:
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27/07/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Teriparatide for Postsurgical Hypoparathyroidism
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Scientific title:
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Pilot Study of Teriparatide for Postsurgical Hypoparathyroidism |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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5 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01171690 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Marius Stan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypoparathyroidism Post-surgical
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Intervention(s)
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Drug: Teriparatide
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Primary Outcome(s)
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Hospital Length of Stay
[Time Frame: Approximately 7 days after surgery]
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Secondary Outcome(s)
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Safety Analysis
[Time Frame: Approximately 90 days after surgery]
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Secondary ID(s)
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10-000901
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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