Clinical Trial: 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 Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief Summary: 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.
Detailed Summary:
Sponsor: Amgen
Current Primary Outcome: Nature, frequency, severity, and relationship to treatment of adverse events [ Time Frame: 234 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Calcium levels and plasma iPTH during the maintenance phase [ Time Frame: 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 [ Time Frame: 234 weeks ]
Original Secondary Outcome: Same as current
Information By: Amgen
Dates:
Date Received: June 4, 2009
Date Started: November 2000
Date Completion:
Last Updated: May 6, 2013
Last Verified: May 2013
