| Trial ID: | L1594 |
| Source ID: | NCT00395382
|
| Associated Drug: |
Alendronate
|
| Title: |
Study of the Effect of Alendronate on Vascular Calcification and Arterial Stiffness in Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Vascular Calcification|Arteriosclerosis
|
| Interventions: |
DRUG: Alendronate|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in degree of arterial stiffness measured by pulse wave velocity, 18 months|Changes in vascular calcification on CT scans of superficial femoral artery and aorta, 18 months | Secondary: Changes in bone mineral density, 18 months|Changes in serum calcium and phosphate levels, 18 months|Cardiovascular events including myocardial ischaemia, myocardial infarction, cardiac failure, stroke, PVD, 18 months|Incidence of fractures, 18 months|Symptoms and severity of side effects from alendronate, 18 months|Episodes of hypocalcemia (serum corrected calcium <2.10mmol/L), 18 months
|
| Sponsor/Collaborators: |
Sponsor: Monash University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2007-01
|
| Completion Date: |
2009-09
|
| Results First Posted: |
|
| Last Update Posted: |
2010-02-09
|
| Locations: |
Department of Nephrology, Monash Medical Centre, Clayton, Victoria, 3168, Australia
|
| URL: |
https://clinicaltrials.gov/show/NCT00395382
|
