Long-term Effect of Lanthanum Carbonate on Bone

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.

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Key information

Conditions

Hyperphosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Bad König, Hesse, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Lanthanum carbonate

Drug

Primary outcomes

Number of Study-emergent Bone-related Adverse Events (AEs)

Time frame: 5 years

Secondary outcomes

Number of Study-emergent Deaths

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: Nov 14, 2007
Registry last updated: Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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