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

Hyperparathyroidism, Primary Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936988
• Other study ID #: 20000159
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2009
• Last updated: May 6, 2013
• Start date: November 2000
• Est. completion date: December 2005

Study information

• Verified date: May 2013
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary

Intervention

Drug:
• cinacalcet
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (1)

Peacock M, Bolognese MA, Borofsky M, Scumpia S, Sterling LR, Cheng S, Shoback D. Cinacalcet treatment of primary hyperparathyroidism: biochemical and bone densitometric outcomes in a five-year study. J Clin Endocrinol Metab. 2009 Dec;94(12):4860-7. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nature, frequency, severity, and relationship to treatment of adverse events		234 weeks	No
Secondary	Calcium levels and plasma iPTH during the maintenance phase		234 weeks	No
Secondary	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	No

External Links

•   AmgenTrials clinical trials website