NCT00037518

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 17, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2002

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

First QC Date

May 17, 2002

Last Update Submit

May 6, 2013

Conditions

HyperparathyroidismParathyroid Neoplasms

Keywords

Severe primary hyperparathyroidismParathyroid carcinoma

Outcome Measures

Primary Outcomes (1)

  • Changes in serum calcium and PTH

Secondary Outcomes (1)

  • Safety and tolerability of cinacalcet

Interventions

AMG 073DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 17666472RESULT

  • 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.

    PMID: 19470620RESULT

  • 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.

    PMID: 20943783DERIVED

Related Links

MeSH Terms

Conditions

HyperparathyroidismParathyroid NeoplasmsHyperparathyroidism, Primary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2002

First Posted

May 20, 2002

Study Start

April 1, 2001

Last Updated

May 8, 2013

Record last verified: 2013-05