Protocol Number: 08-CH-0203

Title:

A Pilot Study to Assess the Feasibility of PTH-1-34 Therapy via Pump in the Management of Chronic Hypoparathyroidism

Number:

08-CH-0203

Summary:

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.

Sponsoring Institute:

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility 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.

Special Instructions:

Currently Not Provided

Keywords:

Hypoparathyroidism

Parathyroid Hormone 1-34

Recruitment Keyword(s):

Hypoparathyroidism

Condition(s):

Hypoparathyroidism

Hypocalcemia

Investigational Drug(s):

Synthetic Human Parathyroid Hormone 1-34

Investigational Device(s):

None

Intervention(s):

Drug: Synthetic Human Parathyroid Hormone 1-34

Supporting Site:

National Institute of Child Health and Human Development

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Chan JC, Young RB, Alon U, Mamunes P. Hypercalcemia in children with disorders of calcium and phosphate metabolism during long-term treatment with 1,25-dihydroxyvitamin-D3. Pediatrics. 1983 Aug;72(2):225-33.

Chan JC, Young RB, Hartenberg MA, Chinchilli VM. Calcium and phosphate metabolism in children with idiopathic hypoparathyroidism or pseudohypoparathyroidism: effects of 1,25-dihydroxyvitamin D3. J Pediatr. 1985 Mar;106(3):421-6.

Christiansen C, Rodbro P, Christensen MS, Hartnack B, Transbol I. Deterioration of renal function during treatment of chronic renal failure with 1,25-dihydroxycholecalciferol. Lancet. 1978 Sep 30;2(8092 Pt 1):700-3.

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