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Sponsored by: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00743782 |
This study will evaluate the safety and effectiveness of parathyroid hormone (PTH) therapy for patients with hypoparathyroidism delivered through a pumping device as compared with injections of the hormone. Patients with hypoparathyroidism have abnormalities in mineral metabolism that cause low blood levels of calcium. Patients can develop painful muscle spasms, seizures and kidney problems. Neither standard treatment with calcium or hormone replacement therapy with twice daily PTH injections is entirely effective in controlling all the mineral abnormalities. This study will see if a steady release of PTH via pump therapy is more beneficial for patients with hypoparathyroidism than injections.
Patients between 18 and 70 years of age who have had chronic hypoparathyroidism for at least 1 year may be eligible for this study. Participants have two 10- 12-day hospital admissions and one 5-day admission. The first two inpatient admissions are separated by 3-month outpatient periods. Outpatient monitoring will require weekly blood tests and monthly urine tests to monitor mineral levels. After third hospital admission, patients will be placed on conventional therapy.
Condition | Intervention | Phase |
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Hypoparathyroidism Hypocalcemia |
Drug: Synthetic Human Parathyroid Hormone 1-34 |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study |
Official Title: | A Pilot Study to Assess the Feasibility of PTH 1-34 Therapy Via Pump in the Management of Chronic Hypoparathyroidism |
Estimated Enrollment: | 8 |
Study Start Date: | August 2008 |
Prior studies (92-CH-0011) have been important in establishing synthetic human parathyroid hormone l-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. The simultaneous normalization of serum and urine calcium, phosphorus, magnesium and markers of bone turnover remains the main goal of this hormone replacement therapy. Abnormalities in mineral homeostasis, characteristic of hypoparathyroidism, are not remedied with conventional therapy and remain problematic with both once and twice daily PTH injection therapy. Further refinement and physiologic control of calcium metabolism in PTH replacement therapy of hypoparathyroidism are needed. We will be conducting a short-term, inpatient-outpatient study of 8 subjects in a randomized crossover study comparing twice-daily subcutaneous injections vs. PTH pump therapy. We hypothesize that PTH pump therapy will provide smoother metabolic control of serum mineral levels and normalization of urine mineral excretion compared to a twice-daily regimen. There will be two arms to the study and each arm will be divided into an inpatient and an outpatient phase. There will be three inpatient admissions: baseline, 3 months, and 6 months. Subjects will be randomized to either pump therapy or to twice daily injections at the beginning of the study and will cross over to the alternate PTH delivery system (injections vs. pump) at the conclusion of the initial 3-month treatment period. A main purpose of the study is to gain experience with the use of PTH pump therapy as an alternative to multiple daily injections. Although the pump is widely used in type 1 diabetes for delivery of insulin, this delivery system has never been implemented for PTH therapy in hypoparathyroidism. This study will provide data on the ability of the pump to maintain normal mineral levels and to verify that the device does not adversely impact calcemic control or patient compliance. Additionally, information will be obtained with regard to whether pump therapy is sufficiently well tolerated to expect that adherence will be satisfactory.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
This study will include patients of both genders (ages 18-70) with biochemically confirmed chronic hypoparathyroidism of at least one year duration. Eight adult subjects will be enrolled.
EXCLUSION CRITERIA:
Subjects who meet any of the following criteria are not eligible for the study:
EXCLUSION CRITERIA FOR BIODEX MUSCLE TESTING IN THE RMD:
Subjects with the following conditions will not participate in the biodex testing portion of the protocol:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 080203, 08-CH-0203 |
Study First Received: | August 28, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00743782 |
Health Authority: | United States: Federal Government |
Hypoparathyroidism Parathyroid Hormone 1-34 Hypoparathyroidism |
Parathyroid Diseases Hypocalcemia Metabolic Diseases Endocrine System Diseases |
Water-Electrolyte Imbalance Endocrinopathy Hypoparathyroidism Metabolic disorder |
Calcium Metabolism Disorders |