A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

This study has been completed.

Study NCT00081653 Information provided by Hoffmann-La Roche

First Received: April 19, 2004 Last Updated: June 2, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Condition:	Post-Menopausal Osteoporosis
Intervention:	Drug: ibandronate [Bonviva/Boniva]

Participant Flow

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Baseline Characteristics

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Reporting Groups

	Description
Group A	100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
Group B	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Baseline Measures

	Group A	Group B	Total
Number of Participants [units: participants]	358	361	719
Age [units: years] Mean ± Standard Deviation	67.8 ± 6.55	67.7 ± 6.8	67.7 ± 6.7
Gender [units: participants]
Female	358	361	719
Male	0	0	0
Race/Ethnicity, Customized [units: participants]
Caucasian/White	341	338	679
Black	0	1	1
Oriental	0	1	1
Hispanic	17	20	37
Other	0	1	1
BMI (kg/m2) [units: kg/m2] Mean ± Standard Deviation	25.87 ± 4.957	26.04 ± 3.976	25.96 ± 4.489

Outcome Measures

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1. Primary:

Relative (%) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD [ Assessed at Baseline +12, 24, and 36 months ]

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2. Primary:

Absolute (g/cm2) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD [ Assessed at baseline +12, 24 and 36 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 NOT 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.

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
There were no overall limitations and caveats.

Results Point of Contact:

Name/Title: Clinical Trials Study Director
Organization: Hoffmann-La Roche
phone: +1 973 235 5000

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	MA17903
Study First Received:	April 19, 2004
Results First Received:	December 22, 2008
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00081653 History of Changes
Health Authority:	United States: Food and Drug Administration