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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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from 31 centers over the period of 18 May 2004 to 28 Nov 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible for the study were patients having completed study BM16549 and who had complied with the monthly regimen for 75% or more.

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)

Participant Flow: Overall Study

	Group A	Group B
STARTED	358^[1]	361^[2]
COMPLETED	311^[3]	324^[4]
NOT COMPLETED	47	37
Withdrawn from treatment	47	37

[1]	Patients entering MA17903 from Study BM16549
[2]	Patients entering MA17903 from Study BM16549
[3]	Completed 3 years of treatment
[4]	Completed 3 years of treatment

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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Measure Type	Primary
Measure Title	Relative (%) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD
Measure Description	Relative (%) change from MA17903 baseline in mean BMD of the lumbar spine (L2 - L4) at 12, 24 and 36 months
Time Frame	Assessed at Baseline +12, 24, and 36 months
Safety Issue	No

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.
Of the 719 patients randomized to treatment, a similar percentage of patients (87% in the 100 mg monthly group and 90% in the 150 mg monthly group) completed the full 3 years of treatment in study MA17903. Eighty four patients withdrew from the study.

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)

Measured Values

	Group A	Group B
Number of Participants Analyzed [units: participants]	348	350
Relative (%) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD [units: %] Mean ± Standard Deviation
Month 12	0.8348 ± 3.8118	1.2550 ± 3.6402
Month 24	1.6921 ± 4.2385	1.7865 ± 4.5058
Month 36	2.1794 ± 4.9176	2.4322 ± 4.8146

No statistical analysis provided for Relative (%) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD

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