| Trial ID: | L0749 |
| Source ID: | NCT02440581
|
| Associated Drug: |
Alendronate
|
| Title: |
Renal Osteodystrophy: An Individual Management Approach
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02440581/results
|
| Conditions: |
Kidney Failure, Chronic
|
| Interventions: |
DRUG: Alendronate|DRUG: Teriparatide|DRUG: Cinacalcet
|
| Outcome Measures: |
Primary: Change in Quantitative Computed Tomography (QCT) Bone Mineral Density of the Hip, At one year the investigators will asses bone mass using QCT of the total hip and compare one year changes in bone mass between the treatment and control groups., One Year (at baseline and one year) | Secondary: Change in Coronary Artery Calcifications by Multiple Detector Computed Tomography (MDCT), At one year the investigators will asses differences between the treatment and control groups in changes in Coronary Artery Calcifications by MDCT. 1 Yr. Change in Sqrt CAC Vol., One year (at baseline and one year)|Change in Serum Biochemical Bone Markers of Bone Activity - Parathyroid Hormone (PTH), Bone markers of bone activity tracked over time for changes.1 Yr. Change in PTH, 1 Year (at baseline and one year)|Change in Serum Biochemical Bone Markers of Bone Activity - Bone-specific Alkaline Phosphatase (BSAP), Bone markers of bone activity tracked over time for changes.1 Yr. Change in BSAP, 1 year (at baseline and one year)|Change in Serum Biochemical Bone Markers of Bone Activity - Fibroblast Growth Factor 23 (FGF23), Bone markers of bone activity tracked over time for changes. 1 Yr. Change in FGF-23, 1 Year (at baseline and 1 year)
|
| Sponsor/Collaborators: |
Sponsor: Hartmut Malluche, MD | Collaborators: Wright State University|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
141
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-07-01
|
| Completion Date: |
2021-06-30
|
| Results First Posted: |
2023-01-05
|
| Last Update Posted: |
2023-01-05
|
| Locations: |
University of Kentucky, Lexington, Kentucky, 40536, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02440581
|
