Comparing Pump With Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00743782 |
Recruitment Status
:
Completed
First Posted
: August 29, 2008
Last Update Posted
: April 23, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoparathyroidism Hypocalcemia | Drug: Synthetic Human Parathyroid Hormone 1-34 | Early Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparing Pump vs. Subcutaneous Injection Delivery of PTH 1-34 in the Management of Chronic Hypoparathyroidism |
Study Start Date : | August 22, 2008 |
Actual Primary Completion Date : | April 7, 2014 |
Actual Study Completion Date : | April 7, 2014 |

- Assess the feasability of PTH 1-34 therapy via pump.
- This pilot study is being conducted to compare PTH therapy via pump vs. twice daily subcutaneous injections.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 7 Years to 70 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743782
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
Principal Investigator: | Karen K Winer, M.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00743782 History of Changes |
Other Study ID Numbers: |
080203 08-CH-0203 |
First Posted: | August 29, 2008 Key Record Dates |
Last Update Posted: | April 23, 2018 |
Last Verified: | April 7, 2014 |
Keywords provided by National Institutes of Health Clinical Center (CC):
Hypoparathyroidism Parathyroid Hormone 1-34 |
Additional relevant MeSH terms:
Hypoparathyroidism Hypocalcemia Parathyroid Diseases Endocrine System Diseases Calcium Metabolism Disorders |
Metabolic Diseases Water-Electrolyte Imbalance Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |