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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

Primary Purpose

Hyperparathyroidism, Primary

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cinacalcet
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperparathyroidism, Primary focused on measuring Hyperparathyroidism, Primary, cinacalcet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    cinacalcet

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Calcium levels and plasma iPTH during the maintenance phase
    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

    Full Information

    First Posted
    June 4, 2009
    Last Updated
    May 6, 2013
    Sponsor
    Amgen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00936988
    Brief 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
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2000 (undefined)
    Primary Completion Date
    June 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperparathyroidism, Primary
    Keywords
    Hyperparathyroidism, Primary, cinacalcet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cinacalcet
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    cinacalcet
    Intervention Description
    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 Outcome Measure Information:
    Title
    Nature, frequency, severity, and relationship to treatment of adverse events
    Time Frame
    234 weeks
    Secondary Outcome Measure Information:
    Title
    Calcium levels and plasma iPTH during the maintenance phase
    Time Frame
    234 weeks
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19837909
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    20943783
    Citation
    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.
    Results Reference
    derived
    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    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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