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

NCT00936988 | Completed Phase 2

• 1 other identifier: 20000159
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperparathyroidism, Primary

Keywords

Hyperparathyroidism, Primary; cinacalcet

Outcome Measures

Primary Outcomes (1)

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

  234 weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

cinacalcet

EXPERIMENTAL

Drug: cinacalcet

Interventions

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.

cinacalcet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Publications (2)

• 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: 10.1210/jc.2009-1472. Epub 2009 Oct 16.

  PMID: 19837909 RESULT

• Peacock M, Bilezikian JP, Bolognese MA, Borofsky M, Scumpia S, Sterling LR, Cheng S, Shoback D. Cinacalcet HCl reduces hypercalcemia in primary hyperparathyroidism across a wide spectrum of disease severity. J Clin Endocrinol Metab. 2011 Jan;96(1):E9-18. doi: 10.1210/jc.2010-1221. Epub 2010 Oct 13.

  PMID: 20943783 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: July 10, 2009
• Study Start: November 1, 2000
• Primary Completion: June 1, 2005
• Study Completion: December 1, 2005
• Last Updated: May 8, 2013

Record last verified: 2013-05