Denosumab in Metabolic Bone Disease in Chronic Intestinal Failure Patients
NCT ID: NCT02853539
Last Updated: 2016-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2011-01-31
2016-07-31
Brief Summary
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Detailed Description
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Between November 2011 and March 2013 denosumab was administered to 16 HPN patients (9 F, 7 M mean age 55.4) with intestinal failure. Regional dual-energy x-ray absorptiometry of spine and hip were performed before the therapy was initiated, and after 12 months. BMD, T-score and Z-score were measured.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Denosumab
One per 6 months subcutaneous injection of Denosumab (2 doses in total)
Denosumab
Subcutaneous injection of Denosumab
No Denosumab
No intervention, just observation of HPN patients
No interventions assigned to this group
Interventions
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Denosumab
Subcutaneous injection of Denosumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* bone disease measurement
Exclusion Criteria
* diagnostic modalities impossible
18 Years
ALL
No
Sponsors
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Stanley Dudrick's Memorial Hospital
OTHER
Responsible Party
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Stanislaw Klek
Head of the Department
Locations
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Stanley Dudrick's Memorial Hospital
Skawina, , Poland
Countries
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Other Identifiers
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Denozumab
Identifier Type: -
Identifier Source: org_study_id
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