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

Amgen0 sites45 target enrollmentNovember 2000

ConditionsHyperparathyroidism, Primary

Interventionscinacalcet

Drugscinacalcet

Overview

Phase: Phase 2
Intervention: cinacalcet
Conditions: Hyperparathyroidism, Primary
Sponsor: Amgen
Enrollment: 45
Primary Endpoint: Nature, frequency, severity, and relationship to treatment of adverse events
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2000

End Date

December 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amgen

Eligibility Criteria

Inclusion Criteria

•Successfully completed the parent study 990120
•Agreed to use highly effective (in the opinion of the principal investigator) contraceptive measures throughout the study
•Were able to comprehend and were willing to give written informed consent for participation in the study

Exclusion Criteria

•Pregnant or breast-feeding
•Had a psychiatric disorder that interfered with the understanding and giving of informed consent or compliance with protocol requirements
•Had any other condition that reduced the chance of obtaining data (eg, known poor compliance)
•Participating in another investigational study at the time of study entry
•Had any unstable medical condition, defined as having been hospitalized within 28 days before day 1, or otherwise unstable in the judgment of the investigator

Arms & Interventions

cinacalcet

Intervention: cinacalcet

Outcomes

Primary Outcomes

Nature, frequency, severity, and relationship to treatment of adverse events

Time Frame: 234 weeks

Secondary Outcomes

Calcium levels and plasma iPTH during the maintenance phase(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(234 weeks)