Study Complete
Sponsor ID
20000159
A Multicenter, Open-label Extension Study to Assess the Long-term Safety and Efficacy of an Oral Calcimimetic Agent AMG 073 (cinacalcet) in Primary Hyperparathyroidism
Study Details
This multicenter, open-label, single-arm, extension study was designed to evaluate long-term tolerability, safety, and efficacy of cinacalcet. Subjects were enrolled immediately after they completed the parent study, 990120. All subjects began treatment with 30 mg cinacalcet twice daily (BID), with dose adjustments made per protocol-specified guidelines. The study consisted of 2 consecutive phases that occurred in the following order: a dose-titration phase lasting 12 weeks and a maintenance phase lasting approximately 4½ years.
Protocol Summary
Primary Outcome Measures
Nature, frequency, severity, and relationship to treatment of adverse events
Timeframe: 234 weeks
Secondary Outcome Measures
Calcium levels and plasma iPTH during the maintenance phase
Timeframe: 234 weeks
Percentage changes in BMD from baseline of the parent study to each measurement time point and absolute BMD values, as assessed by DXA scans of proximal femur, lumbar spine (L1-L4), forearm, and total body scans
Timeframe: 234 weeks
Locations
No locations found.