Long-term Effect of Lanthanum Carbonate on Bone

A Long-term, Observational Study to Monitor Mortality, Bone-related Adverse Events and the Safety of Subjects Who Were Recruited Into Study SPD405-309

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.

Study Overview

• Status: Completed
• Conditions: Hyperphosphatemia
• Intervention / Treatment: Drug: Lanthanum carbonate

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patients from study SPD405-309 who were exposed to lanthanum carbonate

Description

Inclusion Criteria:

• Any patient who had exposure to lanthanum carbonate in SPD405-309

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Patients being treated for hyperphosphatemia with any marketed product	Drug: Lanthanum carbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Study-emergent Bone-related Adverse Events (AEs)	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Study-emergent Deaths	5 years

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2007
• Primary Completion (Actual): August 31, 2010
• Study Completion (Actual): August 31, 2010

Study Registration Dates

• First Submitted: November 12, 2007
• First Submitted That Met QC Criteria: November 13, 2007
• First Posted (Estimate): November 14, 2007

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Phosphorus Metabolism Disorders; Hyperphosphatemia
• Other Study ID Numbers: SPD405-402