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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

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ClinicalTrials.gov Identifier: NCT00936988
Recruitment Status : Completed
First Posted : July 10, 2009
Last Update Posted : May 8, 2013
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Primary Drug: cinacalcet Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2000
Primary Completion Date : June 2005
Study Completion Date : December 2005


Arms and Interventions

Arm Intervention/treatment
Experimental: cinacalcet 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.


Outcome Measures

Primary Outcome Measures :
  1. Nature, frequency, severity, and relationship to treatment of adverse events [ Time Frame: 234 weeks ]

Secondary Outcome Measures :
  1. Calcium levels and plasma iPTH during the maintenance phase [ Time Frame: 234 weeks ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936988


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00936988     History of Changes
Other Study ID Numbers: 20000159
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Keywords provided by Amgen:
Hyperparathyroidism, Primary
cinacalcet

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Cinacalcet Hydrochloride
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs