Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

Study Overview
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Brief Summary
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This study will evaluate the safety, biological activity, and pharmacokinetics of PTH delivered by subcutaneous injection compared with an infusion pump. We anticipate pump delivery of PTH will be more physiologic because it mimics normal parathyroid gland secretion of PTH. We expect that pump delivery will simultaneously normalize blood and urine calcium, phosphorus and magnesium levels with minimal or no fluctuations throughout the day. Pump therapy will require lower PTH doses and should normalize markers of bone turnover. We expect the improved metabolic control during pump therapy will be especially evident in patients with more severe forms of hypoparathyrodism where there is an unmet need for improved therapy.

Detailed Description
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Prior studies (92-CH-0011) have been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. We are conducting a randomized crossover study comparing twice-daily subcutaneous injections vs. PTH pump therapy. We hypothesize that pump delivery of PTH 1-34, compared to twice-daily administration, will provide smoother metabolic control of serum mineral levels and normalization of urine mineral excretion. The two arms 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. Patients between 10 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.

Official Title
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Comparing Pump vs. Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism

Conditions
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Hypoparathyroidism, Hypocalcemia

Intervention / Treatment
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* Drug: Synthetic Human Parathyroid Hormone 1-34


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Synthetic Human Parathyroid Hormone 1-34|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the feasability of PTH 1-34 therapy via pump. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This pilot study is being conducted to compare PTH therapy via pump vs. twice daily subcutaneous injections. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoparathyroidism, Parathyroid Hormone 1-34