Cinacalcet for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
The 1st phase of the study will assess the acute biochemical response of PTH, calcium and phosphorus to orally administered doses of cinacalcet once (60mg) or twice (30mg x 2) per day.
The 2nd phase of the study designed to evaluate the long term effects of cinacalcet on BMD (bone mineral density)and the levels of PTH, calcium, phosphorus as well as its ability to control secondary hyperparathyroidism without simultaneous administration of other vitamin D compounds.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Effects of cinacalcet on bone mineral density and bone histology in hemodialysis patients [ Time Frame: one year period ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2006|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446329
|Papageorgiou General Hospital|
|Thessaloniki, Greece, 56403|
|Principal Investigator:||Efstathios Mitsopoulos, MD||Papageorgiou General Hospital, Thessaloniki, Greece|