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

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.

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Key information

Conditions

Hyperparathyroidism, Primary Endocrine System Diseases Hyperparathyroidism Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cinacalcet

Drug

Subjects began open-label treatment with 30 mg cinacalcet twice daily (BID) at the start of the current study. The study consisted of 2 phases planned to total approximately 4¾ years: a 12-week dosetitration phase (visits at weeks 2, 3, 4, 6, 9, and 12) during which 1 possible dose increase of cinacalcet from 30 mg BID to 50 mg BID could occur at week 6, and a maintenance phase (week 12 to 234; visits approximately every 4 weeks until week 24 and approximately every 14 weeks thereafter) during which doses also could be titrated. After July 2004, because of a change in dose strengths, the daily doses used in the study were 30 and 60 mg BID with the option to reduce to 30 mg once daily (QD), if necessary. Ongoing subjects receiving 50 mg BID were switched at that time to 60 mg BID.

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

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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start: 2000
Primary completion: 2005
Study completion: 2005
First posted: Jul 10, 2009
Registry last updated: May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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