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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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12 December 2020 |
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Main ID: |
NCT00743782 |
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Date of registration:
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28/08/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
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Scientific title:
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Comparing Pump vs. Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism |
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Date of first enrolment:
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August 22, 2008 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00743782 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Early Phase 1
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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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Karen K Winer, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
This study will include patients of both genders (ages 7-70) with biochemically confirmed
chronic hypoparathyroidism of at least one year duration. Twenty-four subjects will be
enrolled.
EXCLUSION CRITERIA:
Subjects who meet any of the following criteria are not eligible for the study:
- Pregnancy
- Patients who are calcium infusion dependent and/or do not respond to calcitriol
therapy to maintain normal levels of serum calcium will be excluded.
- Seizure disorder requiring antiepileptic medications.
Age minimum:
7 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypocalcemia
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Hypoparathyroidism
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Intervention(s)
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Drug: Synthetic Human Parathyroid Hormone 1-34
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Primary Outcome(s)
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Assess the feasability of PTH 1-34 therapy via pump.
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Secondary Outcome(s)
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This pilot study is being conducted to compare PTH therapy via pump vs. twice daily subcutaneous injections.
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Secondary ID(s)
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080203
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08-CH-0203
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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