Status:
TERMINATED
rhPTH Therapy for Low Turnover Bone Fragility
Lead Sponsor:
University of Chicago
Conditions:
Osteopetrosis
Eligibility:
All Genders
20+ years
Phase:
PHASE1
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 Description
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 b...
Eligibility Criteria
Inclusion
- :patients with history of increased bone fragility by BMD criteria (T score \> -1). In addition, the subjects will be enrolled only if they have clear evidence of low bone turnover as indicated by low normal levels of biochemical markers of bone turnover and finding of low bone turnover on bone biopsy. Each subject and his/her treating physician will have agreed that the rhPTH is the best treatment for the patient. Treatment with rhPTH will be considered only if the bone histomorphometry reveals a low turnover state and excludes other known forms of bone disease such as osteomalacia.
Exclusion
- Subjects who are pregnant or younger than 20 will be excluded. Subjects cannot have osteoporosis
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00145886
Start Date
February 1 2003
End Date
September 1 2011
Last Update
January 12 2016
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637