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Sponsored by: |
University of Chicago |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00145886 |
The purpose of this study is to determine how treatment with a new medication, recombinant human parathyroid hormone (rhPTH) affects calcium balance and bone strength.
Condition | Intervention |
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Osteopetrosis |
Drug: Forteo (teriparatide) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Effect of 12 Months Treatment With rhPTH on Calcium Balance, Bone Turnover, Bone Mineral Density, and Bone Micro-Architecture in Patients With Fractures Associated With Low Bone Turnover and Sclerosing Bone Disorders |
Estimated Enrollment: | 10 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | July 2010 |
Subjects will have had a bone biopsy to definitively determine low bone turnover. Subjects and the treating doctor decide that treatment with rhPTH (recombinant human parathyroid hormone) is optimal before admission into the study. During the study, subjects will have several tests that will clarify how rhPTH is affecting calcium metabolism and bone properties. All of the studies will be performed in the University of Chicago General Clinical Research Center (GCRC).
To examine the effects of PTH (parathyroid hormone) on calcium metabolism, subjects will be admitted to the GCRC for 3 days in the beginning of the study. Subjects will have a plastic needle inserted into a vein to enable the nurses to draw your blood repeatedly without having to stick you every time. Subjects will have 120 mL (about 8 tablespoons) of blood drawn during the 3 day period. Subjects will be allowed to choose the food from the regular hospital menu but the amount of calcium from the diet will be the same during each day that you spend in the GCRC. The first day will be used to observe calcium balance without medication while the subsequent 2 days will be used to determine how calcium balance changes in response to the medication rhPTH. Subjects will take the medication in the morning, before breakfast - this will be considered time 0. During all 3 days, blood will be taken at 0, 2, 4, 6, 8, 12, 16, and 20 hours for examination of serum calcium and at 0, 4 and 12 hours for measurement of PTH (that is produced by your body).
On the first and 3rd day all the urine will be collected to measure how much calcium is lost in the urine.
After Subjects have received the medication for 3 months they will again be admitted to the GCRC, this time for 2 days during which they will continue to take the medication with the same measurements as on the last 2 days of the first admission. The same admission will be repeated after 12 months of treatment. During each of these admissions, you will have 80 mL (about 5 ½ tablespoons) of blood drawn.
In addition to these 3 inpatient stays in the CRC, subjects will also have several tests as an outpatient. The tests will be used to evaluate the effect of rhPTH on the bone. To this end, you will have 3 types of tests.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Ann Pham 773-702-1997 apham@medicine.bsd.uchicago.edu | |
Principal Investigator: Tamara Vokes, MD |
Principal Investigator: | Tamara Vokes, MD | University of Chicago |
Study ID Numbers: | 12901A |
Study First Received: | September 1, 2005 |
Last Updated: | October 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00145886 |
Health Authority: | United States: Institutional Review Board |
low bone turnover; sclerosing bone disorders, osteopetrosis |
Calcium, Dietary Osteopetrosis Musculoskeletal Diseases Teriparatide Fractures, Bone |
Bone Diseases, Developmental Osteochondrodysplasias Bone Diseases Albers-Schonberg disease |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions Osteosclerosis |