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Withdrawn from treatment	47	37

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/m**2)   [units: kg/m**2] Mean ± Standard Deviation	25.87 ± 4.957	26.04 ± 3.976	25.96 ± 4.489

1.  Primary:

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

2.  Primary:

Absolute (g/cm2) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD   [ Assessed at baseline +12, 24 and 36 months ]