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Long-term Effect of Lanthanum Carbonate on Bone

This study has been completed.
Information provided by (Responsible Party):
Shire Identifier:
First received: November 12, 2007
Last updated: March 4, 2015
Last verified: May 2011
Patients enrolled in a previous study (SPD405-309), who were exposed to lanthanum carbonate (Fosrenol), were eligible to continue on any prescribed treatment for hyperphosphatemia, including lanthanum carbonate (Fosrenol), for an additional 5 years. Patients were being observed for any bone adverse events or other serious adverse events, as well as the collection of mortality data.

Condition Intervention
Hyperphosphatemia Drug: Lanthanum carbonate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long-term, Observational Study to Monitor Mortality, Bone-related Adverse Events and the Safety of Subjects Who Were Recruited Into Study SPD405-309

Resource links provided by NLM:

Further study details as provided by Shire:

Primary Outcome Measures:
  • Number of Study-emergent Bone-related Adverse Events (AEs) [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Number of Study-emergent Deaths [ Time Frame: 5 years ]

Enrollment: 34
Study Start Date: August 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients being treated for hyperphosphatemia with any marketed product
Drug: Lanthanum carbonate


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients from study SPD405-309 who were exposed to lanthanum carbonate

Inclusion Criteria:

  • Any patient who had exposure to lanthanum carbonate in SPD405-309
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00557323

United States, California
Imperial care Dialysis Center
Lynwood, California, United States, 90262
Barnett Research and Communications Medical Group
Torrance, California, United States, 90503-4100
United States, Massachusetts
Western new England Renal & Transplant Associates
Springfield, Massachusetts, United States, 01107
United States, Ohio
Mercy Medical Center
Canton, Ohio, United States, 44708
United States, Rhode Island
Hypertension & Nephrology, Inc.
Providence, Rhode Island, United States, 02904
United States, Tennessee
Nephrology Associates, PC
Nashville, Tennessee, United States, 37205
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Nephrology Associates, PC
Richmond, Virginia, United States, 23226-2022
Bad Koenig, HE, Germany, 64732
KfH Zentrum
Aachen, Germany, 52074
Bad Homburg, Germany, 61348
KfH Kuratorium duer Dialyse und Nierentransplanta Dialysezentrum Moabit
Berlin, Germany, 10559
KfH Dialysezentrum
Berlin, Germany, 12045
Dialysezentrum Barmbek
Hamburg, Germany, 22297
Dialysepraxis Altona
Hamburg, Germany, 22767
KfH Dialysezentrum
Rosenheim, Germany, 83022
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CAMBS CB2 2QQ
St. Helier Hospital
Carshalton, United Kingdom, GT LON SM5 1AA
Manchester Royal Infirmary
Manchester, United Kingdom, GT MAN M13 9WL
Sponsors and Collaborators
Principal Investigator: Alastair Hutchison, MD Manchester Royal Infirmary, Manchester, UK
  More Information

Responsible Party: Shire Identifier: NCT00557323     History of Changes
Other Study ID Numbers: SPD405-402
Study First Received: November 12, 2007
Results First Received: May 19, 2011
Last Updated: March 4, 2015

Additional relevant MeSH terms:
Phosphorus Metabolism Disorders
Metabolic Diseases processed this record on September 21, 2017