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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 A larger needle is then inserted into the bone itself, and a sample of bone tissue is withdrawn through the needle.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: | Primary Purpose: Treatment |
| Official Title: | Effects of PTH Replacement on Bone in Hypoparathyroidism |
| Enrollment: | 23 |
| 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) |
Hypoparathyroidism due to inadequate production or secretion of parathyroid hormone (PTH) is associated with hypocalcemia, hyperphosphatemia, suppressed bone turnover and, oftentimes, increased bone mass. It may be due to a variety of genetic disorders, autoimmune conditions and infiltrative diseases or as a result of parathyroid gland injury or removal during neck surgery. Unlike other hormone deficiencies where individuals are treated with replacement hormones, hypoparathyroid patients are typically treated with calcium and vitamin D analogues; however, both the treatment and the underlying disease can lead to hypercalciuria, nephrocalcinosis and decreased renal function.
Prior studies at the NIH have been important in establishing synthetic human parathyroid hormone 1-34 (HPTH) as a beneficial treatment for hypoparathyroidism, possibly superior to conventional therapy with calcium and calcitriol. These noninvasive studies suggest that, although there is no significant effect of long-term treatment with HPTH on bone mass, HPTH therapy leads to a chronic high bone turnover state. The primary goals of this study are to (1) better understand the effects of hypoparathyroidism on the skeleton, and (2) evaluate the skeletal effects of hormone replacement therapy with HPTH in hypoparathyroidism. To accomplish these goals, we will treat hypoparathyroid individuals with synthetic human PTH 1-34 for up to 5 years, periodically assessing skeletal changes through biochemical markers and iliac-crest bone biopsies, which will allow for ultrastructural, cellular, and molecular analyses. This study presents a unique opportunity, through the study of subjects with hypoparathyroidism and their treatment with HPTH, to assess the role of HPTH in human skeletal biology.
Eligibility| Ages Eligible for Study: | 14 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Age eligibility at screening:
EXCLUSION CRITERIA:
Contacts and Locations
More Information
| Responsible Party: | National Institutes of Health ( Rachel I. Gafni, M.D./National Institute of Dental and Craniofacial Research ) |
| Study ID Numbers: | 070016, 07-D-0016 |
| Study First Received: | November 2, 2006 |
| Last Updated: | February 24, 2010 |
| ClinicalTrials.gov Identifier: | NCT00395538 History of Changes |
| Health Authority: | United States: Federal Government |
|
Parathyroid Calcitriol Bone Density |
Skeletal Biology Bone Growth Hypoparathyroidism |
|
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 |