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| Sponsor: | National Institute of Dental and Craniofacial Research (NIDCR) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00395538 |
Purpose
This study will determine whether a synthetic form of human parathyroid hormone (PTH) can control hypoparathyroidism and will examine the drug's effects on bone. Blood calcium and phosphate levels in patients with hypoparathyroidism are difficult to control with the current standard treatment of calcitriol and calcium supplementation. Calcium levels in the urine may be elevated at the same time that blood calcium levels are normal. This spilling of excessive calcium into the urine can lead to kidney damage.
Patients between 9 and 55 years of age with hypoparathyroidism may be eligible for this study. Participants
take standard calcitriol therapy for the first year of the study and start PTH after 1 year. After 1 year on PTH, they are given the option to continue the drug for an additional 3 years.
Patients are admitted to the NIH Clinical Center for 4-6 days at the start of the study, at the end of the first year, and at the end of the second year (and at year 5 for those who continue on PTH for an additional 3 years) for the following procedures:
" Daily 24-hour urine collection.
" Daily blood draw for calcium and phosphorous levels and for calcium-regulating hormones.
" Blood draw every 2 hours for 24 hours to measure blood calcium, phosphorus, and magnesium levels (admission 3 only). For this test blood samples are collected through a catheter (plastic tube) placed in a vein in the arm or hand to avoid multiple needle sticks.
" Questionnaire and 6-minute walk test to determine fatigue
" Bone biopsy to test treatment response. Before the biopsy, patients are given a regimen of the antibiotic tetracycline or demeclocycline. The drug is absorbed by the bone, "labeling" it in a way that permits investigators to learn more about the bone's biology. For the biopsy, the patient is given a sedative to cause drowsiness. The skin over the hipbone is numbed with an injection of anesthetic into the skin, through the underlying tissues, and onto the surface of the bone. A larger needle is then inserted into the bone itself, and a sample of bone tissue is withdrawn through the needle. More sedative or anesthetic may be given to lessen any pain.
Every week for the first month of the study and then twice a month, patients go to a laboratory for a 24-hour urine collection. Every 6 months, they come to the NIH outpatient clinic for a physical exam, blood and urine tests, and a dual energy X-ray absorptiometry (DXA) scan to measure bone density.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypoparathyroidism |
Drug: Parathyroild Hormone 1-34 |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Effects of Calcitriol vs. PTH Replacement Therapy on Bone in Patients With Hypoparathyroidism |
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
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 calcitirol. This study will examine the effects of hypoparathyroidism and two different parathyroid hormone (PTH) replacement regimens on the skeleton of children and adults with hypoparathyroidism. Our prior noninvasive studies of bone mass and turnover suggested that although there was no significant effect of long-term treatment with PTH on bone mass, PTH therapy leads to a chronic high bone turnover state. Ultrastructural, cellular, and molecular analyses are now needed to further examine and characterize both the effect of hypoparathyroidism and treatment with replacement PTH on bone. The primary goals of this study are to (1) understand the effect of absent or low levels of PTH (hypoparathyroidism) and its therapeutic replacement by way of PTH (for the maintenance of calcium homeostasis) on the hypoparathyroid skeleton and (2) characterize bone growth both in the absence of PTH in children with hypoparathyroidism and to then compare the same children on replacement doses of PTH. In the first year of the study, patients will receive conventional (calcitriol plus calcium) therapy, during the second year subjects will be treated with PTH (twice daily vs three times daily), and at the end of the second year subjects will be allowed to continue on PTH for up to an additional three additional years. This study presents a unique opportunity, through the study of subjects with hypoparathyroidism and their treatment with PTH, to assess the role of PTH in human skeletal biology.
Eligibility| Ages Eligible for Study: | 9 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
This study will include patients of both genders (ages 9-55) with biochemically confirmed chronic hypoparathyroidism of at least one year duration. Eighty subjects (30 children and 50 adults) will be enrolled.
EXCLUSION CRITERIA:
Subjects who meet any of the following criteria are not eligible for the study:
Contacts and Locations
More Information
| Responsible Party: | National Institutes of Health ( Michael T. Collins, M.D./National Institute of Dental and Craniofacial Research ) |
| Study ID Numbers: | 070016, 07-D-0016 |
| Study First Received: | November 2, 2006 |
| Last Updated: | August 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00395538 History of Changes |
| Health Authority: | United States: Federal Government |
|
Parathyroid Calcitriol Bone Density Skeletal Biology |
Bone Growth Hypoparathyroidism Bone Density |
|
Parathyroid Diseases Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Calcium Channel Agonists Endocrine System Diseases Bone Density Conservation Agents Cardiovascular Agents |
Pharmacologic Actions Calcitriol Membrane Transport Modulators Therapeutic Uses Vitamins Vasoconstrictor Agents Hypoparathyroidism Micronutrients |