Back to resultsA Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer
Primary Purpose
Hyperparathyroidism, Parathyroid Neoplasms
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
AMG 073
Sponsored by
About this trial
This is an interventional treatment trial for Hyperparathyroidism focused on measuring Severe primary hyperparathyroidism, Parathyroid carcinoma
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Changes in serum calcium and PTH
Secondary Outcome Measures
Safety and tolerability of cinacalcet
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00037518
Brief Title
A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer
Official Title
An Assessment of the Calcimimetic Agent AMG 073 for the Treatment of Subjects With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. Study Description
Brief Summary
This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Parathyroid Neoplasms
Keywords
Severe primary hyperparathyroidism, Parathyroid carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AMG 073
Primary Outcome Measure Information:
Title
Changes in serum calcium and PTH
Secondary Outcome Measure Information:
Title
Safety and tolerability of cinacalcet
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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
17666472
Citation
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. doi: 10.1210/jc.2007-0585. Epub 2007 Jul 31.
Results Reference
result
PubMed Identifier
19470620
Citation
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. doi: 10.1210/jc.2008-2640. Epub 2009 May 26.
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 Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer
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