Clinical Trial: rhPTH Therapy for Low Turnover Bone Fragility

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Sclerosin

Brief Summary: 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.

Detailed Summary:

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
Sponsor: University of Chicago

Current Primary Outcome: To describe the acute effects of rhPTH administration on calcium balance. [ Time Frame: The effects on calcium balance will be examined at the beginning, after 3 months, and after 12 months of treatment with rhPTH. ]

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.


Original Primary Outcome: To describe the acute effects of rhPTH administration on calcium balance.

Current Secondary Outcome: To examine the effect of 12 months of therapy with rhPTH on bone density, bone turnover and bone micro-architecture. [ Time Frame: Bone density will be measured at 0, 3, 6, and 12 months ]

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).


Original Secondary Outcome: To examine the effect of 12 months of therapy with rhPTH on bone density, bone turnover and bone micro-architecture.

Information By: University of Chicago

Dates:
Date Received: September 1, 2005
Date Started: February 2003
Date Completion:
Last Updated: January 8, 2016
Last Verified: January 2016