Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT00037518
Status:
COMPLETED
Last Update Posted:
2013-05-08
First Post:
2002-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010282', 'term': 'Parathyroid Neoplasms'}, {'id': 'D049950', 'term': 'Hyperparathyroidism, Primary'}], 'ancestors': [{'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069449', 'term': 'Cinacalcet'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04'}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-06', 'studyFirstSubmitDate': '2002-05-17', 'studyFirstSubmitQcDate': '2002-05-17', 'lastUpdatePostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in serum calcium and PTH'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of cinacalcet'}]}, 'conditionsModule': {'keywords': ['Severe primary hyperparathyroidism', 'Parathyroid carcinoma'], 'conditions': ['Hyperparathyroidism', 'Parathyroid Neoplasms']}, 'referencesModule': {'references': [{'pmid': '17666472', 'type': 'RESULT', '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.'}, {'pmid': '19470620', 'type': 'RESULT', '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.'}, {'pmid': '20943783', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'This study will assess an investigational medication for patients with severe primary hyperparathyroidism or parathyroid cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* 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.'}, 'identificationModule': {'nctId': 'NCT00037518', 'briefTitle': 'A Study of an Investigational Medication for Severe Primary Hyperparathyroidism or Parathyroid Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'An Assessment of the Calcimimetic Agent AMG 073 for the Treatment of Subjects With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism.', 'orgStudyIdInfo': {'id': '20000204'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AMG 073', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}