Trial record 2 of 45 for:    "familial isolated hyperparathyroidism" OR "Hyperparathyroidism, Primary"

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 study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00936988
First received: June 4, 2009
Last updated: May 6, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Hyperparathyroidism, Primary
Drug: cinacalcet
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Nature, frequency, severity, and relationship to treatment of adverse events [ Time Frame: 234 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Calcium levels and plasma iPTH during the maintenance phase [ Time Frame: 234 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: November 2000
Study Completion Date: December 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936988

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

Additional Information:
Publications:
Additional 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
Study First Received: June 4, 2009
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Hyperparathyroidism, Primary
cinacalcet

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

ClinicalTrials.gov processed this record on September 18, 2014