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Evaluation of Parathyroid Hormone Pump Therapy
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), August 2008
Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00743782
  Purpose

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
Hypoparathyroidism
Hypocalcemia
Drug: Synthetic Human Parathyroid Hormone 1-34
Phase 0

Drug Information available for: Parathyroid
U.S. FDA Resources
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

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Assess the feasability of PTH 1-34 therapy via pump.

Secondary Outcome Measures:
  • This pilot study is being conducted to compare PTH therapy via pump vs. twice daily subcutaneous injections.

Estimated Enrollment: 8
Study Start Date: August 2008
Intervention Details:
    Drug: Synthetic Human Parathyroid Hormone 1-34
    N/A
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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:

  • Presence of significant hepatic or kidney disease (GFR less than 60 mL/min).
  • Pregnancy.
  • Chronic disease that might affect mineral metabolism such as GI disorders, Cushing's syndrome or disease and adrenal insufficiency.
  • Use of systemic or inhaled corticosteroids within the last 6 months.
  • 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.
  • Patients with depression requiring antidepressant medications will be excluded.

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:

  • Any pathology of right knee or elbow consisting of, but not limited to, joint instability, pain or evidence of an active inflammatory or infectious process. Skin in these areas must be intact; there can be no open or healing wound of the right knee or elbow.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743782

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
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

Keywords provided by National Institutes of Health Clinical Center (CC):
Hypoparathyroidism
Parathyroid Hormone 1-34
Hypoparathyroidism

Study placed in the following topic categories:
Parathyroid Diseases
Hypocalcemia
Metabolic Diseases
Endocrine System Diseases
Water-Electrolyte Imbalance
Endocrinopathy
Hypoparathyroidism
Metabolic disorder

Additional relevant MeSH terms:
Calcium Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009