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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: May 17, 2002
Last updated: May 6, 2013
Last verified: May 2013
This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.

Condition Intervention Phase
Parathyroid Neoplasms
Drug: AMG 073
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Changes in serum calcium and PTH

Secondary Outcome Measures:
  • Safety and tolerability of cinacalcet

Estimated Enrollment: 46
Study Start Date: April 2001

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00037518

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Additional 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 
Study First Received: May 17, 2002
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Severe primary hyperparathyroidism
Parathyroid carcinoma

Additional relevant MeSH terms:
Hyperparathyroidism, Primary
Parathyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms by Site
Parathyroid Diseases

ClinicalTrials.gov processed this record on February 07, 2016