A Phase 1 interventional study of rhPTH in Osteopetrosis, sponsored by University of Chicago. Terminated at 1 site in United States. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-01-12.
Sponsored by University of Chicago · Phase 1, Interventional, and Treatment
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.
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.
22 studies on the registry are indexed under Osteopetrosis; 4 are open to participants now.
This study's enrollment of 2 is below the median of 15 across 17 interventional studies indexed under Osteopetrosis.
Browse Osteopetrosis studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will be treated rhPTH for 12 months
Drug: rhPTH
Subjects will be treated with rhPTH for 12 months.
Also known as: Recombinant Human Parathyroid Hormone
To describe the acute effects of rhPTH administration on calcium balance.
The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH. The rational for examining calcium balance at these three time points is that (at least in patients wit osteoporosis treated with PTH) the initial response is primarily an increase in bone formation; at 3 months there is also a proportionate increase in bone resorption; and at 12 months there is an established general increase in bone turnover.
Time frame: The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH.
To examine the effect of 12 months of therapy with rhPTH on bone density, bone turnover and bone micro-architecture.
Bone density will be measured at 0, 3, 6, and 12 months in the lumbar spine, proximal femur, and distal radius using Lunar Prodigy, and in the calcaneus using Lunar PIXI (both from GE Medical Systems, Madison, Wisconsin).
Time frame: Bone density will be measured at 0, 3, 6, and 12 months
The record gives a start of Feb 2003, a primary completion of Sep 2011 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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