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A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer

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ClinicalTrials.gov Identifier: NCT00037518
Recruitment Status : Completed
First Posted : May 20, 2002
Last Update Posted : May 8, 2013
Sponsor:
Information provided by:
Amgen

Brief Summary:
This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism Parathyroid Neoplasms Drug: AMG 073 Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Assessment of the Calcimimetic Agent AMG 073 for the Treatment of Subjects With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism.
Study Start Date : April 2001





Primary Outcome Measures :
  1. Changes in serum calcium and PTH

Secondary Outcome Measures :
  1. Safety and tolerability of cinacalcet


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Patients must have parathyroid carcinoma or severe primary hyperparathyroidism; * Abnormally elevated calcium levels above 12.5 mg/dL; * Not be pregnant or nursing; * Not have had any type of cancer other than parathyroid carcinoma within the last 5 years.

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): NCT00037518


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00037518     History of Changes
Other Study ID Numbers: 20000204
First Posted: May 20, 2002    Key Record Dates
Last Update Posted: May 8, 2013
Last Verified: May 2013

Keywords provided by Amgen:
Severe primary hyperparathyroidism
Parathyroid carcinoma

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