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

Hypoparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743782
• Other study ID #: 080203
• Secondary ID: 08-CH-0203
• Status: Completed
• Phase: Early Phase 1
• Start date: August 22, 2008
• Est. completion date: April 7, 2014

Study information

• Verified date: April 7, 2014
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 7, 2014
• Est. primary completion date: April 7, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 70 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Hypocalcemia
• Hypoparathyroidism

Intervention

Drug:
• Synthetic Human Parathyroid Hormone 1-34

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Winer KK, Ko CW, Reynolds JC, Dowdy K, Keil M, Peterson D, Gerber LH, McGarvey C, Cutler GB Jr. Long-term treatment of hypoparathyroidism: a randomized controlled study comparing parathyroid hormone-(1-34) versus calcitriol and calcium. J Clin Endocrinol Metab. 2003 Sep;88(9):4214-20. — View Citation

Winer KK, Sinaii N, Peterson D, Sainz B Jr, Cutler GB Jr. Effects of once versus twice-daily parathyroid hormone 1-34 therapy in children with hypoparathyroidism. J Clin Endocrinol Metab. 2008 Sep;93(9):3389-95. doi: 10.1210/jc.2007-2552. Epub 2008 May 20. — View Citation

Winer KK, Sinaii N, Reynolds J, Peterson D, Dowdy K, Cutler GB Jr. Long-term treatment of 12 children with chronic hypoparathyroidism: a randomized trial comparing synthetic human parathyroid hormone 1-34 versus calcitriol and calcium. J Clin Endocrinol Metab. 2010 Jun;95(6):2680-8. doi: 10.1210/jc.2009-2464. Epub 2010 Apr 14. — View Citation

Winer KK, Yanovski JA, Cutler GB Jr. Synthetic human parathyroid hormone 1-34 vs calcitriol and calcium in the treatment of hypoparathyroidism. JAMA. 1996 Aug 28;276(8):631-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the feasability of PTH 1-34 therapy via pump.
Secondary	This pilot study is being conducted to compare PTH therapy via pump vs. twice daily subcutaneous injections.