A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer - Full Text View

Purpose

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

Condition	Intervention	Phase
Hyperparathyroidism 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:

Genetics Home Reference related topics: familial isolated hyperparathyroidism hyperparathyroidism-jaw tumor syndrome

MedlinePlus related topics: Cancer

Drug Information available for: Parathyroid Hormone Cinacalcet Cinacalcet hydrochloride

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037518

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications:

Silverberg SJ, Rubin MR, Faiman C, Peacock M, Shoback DM, Smallridge RC, Schwanauer LE, Olson KA, Klassen P, Bilezikian JP. Cinacalcet hydrochloride reduces the serum calcium concentration in inoperable parathyroid carcinoma. J Clin Endocrinol Metab. 2007 Oct;92(10):3803-8. Epub 2007 Jul 31.

Marcocci C, Chanson P, Shoback D, Bilezikian J, Fernandez-Cruz L, Orgiazzi J, Henzen C, Cheng S, Sterling LR, Lu J, Peacock M. Cinacalcet reduces serum calcium concentrations in patients with intractable primary hyperparathyroidism. J Clin Endocrinol Metab. 2009 Aug;94(8):2766-72. Epub 2009 May 26.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2010 Oct 13.

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:

Neoplasms
Hyperparathyroidism
Parathyroid Neoplasms
Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms

Neoplasms by Site
Head and Neck Neoplasms
Calcimimetic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013