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

NCT ID: NCT00037518

Last Updated: 2013-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Brief Summary

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

Detailed Description

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Conditions

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Hyperparathyroidism Parathyroid Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AMG 073

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Amgen Inc.

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

References

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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.

Reference Type RESULT
PMID: 17666472 (View on PubMed)

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.

Reference Type RESULT
PMID: 19470620 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20943783 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20000204

Identifier Type: -

Identifier Source: org_study_id

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