A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

This study has been completed.

Study NCT00551174 Information provided by Hoffmann-La Roche

First Received on October 29, 2007. Last Updated on July 20, 2011 History of Changes

Results First Received: June 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Post-Menopausal Osteoporosis
Intervention:	Drug: ibandronate [Bonviva/Boniva]

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study enrollment was to occur at centers that had participated in BM16550 (NCT00048074) in North America, Mexico, Europe, Australia, and South Africa.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Postmenopausal osteoporosis. Patients having completed study BM16550 (NCT00048074) and who had complied with the intravenous (IV) regimen during the second year of study BM16550 (NCT00048074) for 75% or more.

Reporting Groups

	Description
2 mg Ibandronate q2mo	2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
3 mg Ibandronate q3mo	3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years

Participant Flow: Overall Study

	2 mg Ibandronate q2mo	3 mg Ibandronate q3mo
STARTED	381	400
COMPLETED	362 ^[1]	394 ^[1]
NOT COMPLETED	19	6

[1]	Intent-to-Treat (ITT) Population

Baseline Characteristics

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Reporting Groups

	Description
2 mg Ibandronate q2mo	2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
3 mg Ibandronate q3mo	3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years

Baseline Measures

	2 mg Ibandronate q2mo	3 mg Ibandronate q3mo	Total
Number of Participants [units: participants]	381	400	781
Age [units: years] Mean ± Standard Deviation	68.2 ± 6.1	67.9 ± 6.0	68.0 ± 6.0
Gender [units: participants]
Female	381	400	781
Male	0	0	0
Race/Ethnicity, Customized [units: participants]
Caucasian/White	363	388	751
Black	0	0	0
Oriental	0	0	0
Hispanic	17	11	28
Other	1	1	2
BMI [units: kg/m*2] Mean ± Standard Deviation	25.63 ± 4.295	25.89 ± 4.394	25.76 ± 4.3460

Outcome Measures

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1. Primary:

Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months [ Time Frame: Baseline,12, 24 and 36 months ]

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2. Secondary:

Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months [ Time Frame: Baseline,12, 24 and 36 months ]

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3. Secondary:

Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months [ Time Frame: Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550) ]

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4. Secondary:

Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months [ Time Frame: Baseline, 6 months ]

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Serious Adverse Events

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Other Adverse Events

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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: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00551174 History of Changes
Other Study ID Numbers:	MA17904
Study First Received:	October 29, 2007
Results First Received:	June 30, 2009
Last Updated:	July 20, 2011
Health Authority:	United States: Food and Drug Administration