Long-term Effect of Lanthanum Carbonate on Bone - Study Results

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Hyperphosphatemia
Intervention:	Drug: Lanthanum carbonate

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Followed subjects from study SPD405-309 (NCT00150540) for 5 years.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
5-Year Observational Period	Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.

Description

5-Year Observational Period

Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.

Participant Flow: Overall Study

	5-Year Observational Period
STARTED	34
COMPLETED	27
NOT COMPLETED	7
Death	3
Withdrawal by Subject	2
Administrative change	2

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
5-Year Observational Period	Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.

Description

5-Year Observational Period

Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.

Baseline Measures

	5-Year Observational Period
Overall Participants Analyzed [Units: Participants]	34

Age [Units: Participants] Mean (Standard Deviation)	54.1 (13.3)

Gender [Units: Participants]
Female	9
Male	25

Region of Enrollment [Units: Participants]
United States	12
Germany	18
United Kingdom	4

Outcome Measures

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1. Primary:

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

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2. Secondary:

Number of Study-emergent Deaths [ Time Frame: 5 years ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.

Results Point of Contact:

Name/Title: Timothy Whitaker, M.D.
Organization: Shire Pharmaceutical
e-mail: twhitaker@shire.com

Responsible Party:	Shire
ClinicalTrials.gov 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