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MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00048061
Recruitment Status : Completed
First Posted : October 25, 2002
Results First Posted : May 30, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Post Menopausal Osteoporosis
Interventions Drug: Ibandronate [Bonviva/Boniva]
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D
Enrollment 1609
Recruitment Details The study was conducted from 26 April 2002 to 08 Dec 2004 across 65 centers in the world.
Pre-assignment Details A total of 1609 participants were randomized, of which 1602 received the study drug.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day. Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Period Title: Overall Study
Started 400 401 400 401
Completed 325 328 316 322
Not Completed 75 73 84 79
Reason Not Completed
Adverse Event             41             32             44             37
Lost to Follow-up             3             2             4             5
Withdrawal by Subject             20             29             29             32
Did not follow-up             5             5             4             5
Early improvement             6             5             3             0
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg Total
Hide Arm/Group Description Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. Total of all reporting groups
Overall Number of Baseline Participants 395 396 396 396 1583
Hide Baseline Analysis Population Description
The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 395 participants 396 participants 396 participants 396 participants 1583 participants
65.8  (6.61) 66.0  (6.71) 66.2  (6.38) 66.2  (6.64) 66.0  (6.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 395 participants 396 participants 396 participants 396 participants 1583 participants
Female
395
 100.0%
396
 100.0%
396
 100.0%
396
 100.0%
1583
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 - L4) Bone Mineral Density
Hide Description Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.
Time Frame From Baseline (Month 0) to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 314 322 306 314
Mean (Standard Deviation)
Unit of Measure: Percent change
3.7427  (4.0149) 4.3395  (3.9557) 4.0328  (3.6815) 4.7611  (3.8931)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ibandronate 2.5 mg, Ibandronate 50/50 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The monthly dosing regimen (Ibandronate 50/50 mg monthly) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to –1 percentage point.
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.615
Confidence Interval (2-Sided) 95%
0.013 to 1.216
Estimation Comments Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 50/50) and the active-control.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ibandronate 2.5 mg, Ibandronate 100 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The monthly dosing regimen (Ibandronate 100 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to –1 percentage point.
Statistical Test of Hypothesis P-Value 0.338
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.297
Confidence Interval (2-Sided) 95%
-0.312 to 0.906
Estimation Comments Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 100 mg) and the active-control
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ibandronate 2.5 mg, Ibandronate 150 mg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The monthly dosing regimen (Ibandronate 150 mg) was considered non-inferior to the 2.5 mg daily regimen if the lower bound of the two-sided 95% CI on the difference in mean percent change in BMD was greater or equal to –1 percentage point.
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.000
Confidence Interval (2-Sided) 95%
0.395 to 1.605
Estimation Comments Treatment effect is the difference in the mean values of the monthly oral dose regimens (Ibandronate 150 mg) and the active-control.
2.Secondary Outcome
Title Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Hide Description Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.
Time Frame From Baseline (Month 0) to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 294 294 278 291
Mean (Standard Deviation)
Unit of Measure: Percent change
4.9623  (4.6525) 5.3350  (4.8235) 5.5760  (4.2280) 6.5503  (4.5118)
3.Secondary Outcome
Title Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD
Hide Description The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 - L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.
Time Frame From Baseline (Month 0) to Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 314 322 306 314
Mean (Standard Deviation)
Unit of Measure: g/cm2
At 12 months, n = 314, 322, 306, 314 0.028  (0.0291) 0.033  (0.0298) 0.030  (0.0271) 0.036  (0.0290)
At 24 months, n = 294, 294, 278, 291 0.036  (0.0337) 0.039  (0.0355) 0.042  (0.0313) 0.049  (0.0330)
4.Secondary Outcome
Title Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD
Hide Description Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.
Time Frame From Baseline (Month 0) to Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 315 319 306 316
Mean (Standard Deviation)
Unit of Measure: Percent change
Total hip At Month 12, n = 315,319,306,316 1.9626  (2.8311) 2.2172  (2.7504) 2.6878  (2.6646) 3.0092  (2.7105)
Total hip At Month 24, n = 292,291,277,289 2.4955  (3.0884) 2.8132  (3.2408) 3.5165  (3.2831) 4.1601  (2.8335)
Trochanter At Month 12, n = 315,319,306,316 3.1917  (4.1268) 3.4931  (4.0876) 3.8226  (3.7077) 4.5904  (3.9436)
Trochanter At Month 24, n = 292,291,277,289 4.0204  (4.3460) 4.6289  (4.5518) 5.3135  (4.7335) 6.1755  (4.2550)
Femoral neck At Month 12, n = 315,319,306,316 1.7164  (3.6233) 1.8141  (3.4391) 1.8797  (3.4998) 2.1914  (3.4842)
Femoral neck At Month 24, n=292,291,277,289 1.9087  (4.2212) 2.0581  (4.1189) 2.6209  (3.8339) 3.1195  (4.0549)
5.Secondary Outcome
Title Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.
Hide Description Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center
Time Frame From Baseline (Month 0) to Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 315 319 306 316
Mean (Standard Deviation)
Unit of Measure: g/cm2
Total hip At Month 12, n = 315,319,306,316 0.014  (0.0204) 0.016  (0.0205) 0.020  (0.0190) 0.022  (0.0190)
Total hip At Month 24, n = 292,291,277,290 0.018  (0.0225) 0.021  (0.0241) 0.026  (0.0237) 0.031  (0.0199)
Trochanter At Month 12, n = 315,319,306,316 0.018  (0.0228) 0.020  (0.0238) 0.022  (0.0206) 0.026  (0.0211)
Trochanter At Month 24, n = 292,291,277,290 0.023  (0.0241) 0.027  (0.0259) 0.030  (0.0263) 0.035  (0.0231)
Femoral neck At Month 12, n = 315,319,306,316 0.011  (0.0230) 0.011  (0.0226) 0.012  (0.0228) 0.014  (0.0224)
Femoral neck At Month 24, n = 315,319,306,316 0.012  (0.0265) 0.013  (0.0272) 0.017  (0.0248) 0.020  (0.0257)
6.Secondary Outcome
Title Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24
Hide Description A participant is a responder if the mean lumber spine (L2 - L4) BMD had remained the same or increased above baseline.
Time Frame Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 314 322 306 314
Measure Type: Number
Unit of Measure: Percentage of participants
At Month 12, n = 314,322,306,314 83.8 87.6 86.6 90.8
At Month 24, n = 294,294,278,291 86.4 87.8 87.8 93.5
7.Secondary Outcome
Title Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24
Hide Description A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.
Time Frame Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 315 319 306 306
Measure Type: Number
Unit of Measure: Percentage of participants
At Month 12, n = 315,319,306,306 76.8 81.2 86.9 90.5
At Month 24, n = 292,291,277,289 78.4 83.2 88.8 93.4
8.Secondary Outcome
Title Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24
Hide Description A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.
Time Frame Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 315 319 306 316
Measure Type: Number
Unit of Measure: Percentage of participants
At Month 12, n = 315,319,306,316 80.0 83.1 88.2 92.4
At Month 24, n = 292,291,277,289 84.2 86.6 89.9 94.1
9.Secondary Outcome
Title Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24
Hide Description A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.
Time Frame Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 315 319 306 316
Measure Type: Number
Unit of Measure: Percentage of participants
At Month 12, n = 315,319,306,316 71.1 72.4 69.0 75.3
At Month 24, n = 292,291,277,289 69.2 71.1 78.7 81.0
10.Secondary Outcome
Title Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Hide Description A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.
Time Frame Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 314 318 304 310
Measure Type: Number
Unit of Measure: Percentage of participants
At Month 12, n = 314,318,304,310 65.6 72.3 77.6 83.5
At Month 24, n = 292,291,276,287 70.5 75.3 79.3 87.1
11.Secondary Outcome
Title Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Hide Description A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.
Time Frame Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 314 318 304 310
Measure Type: Number
Unit of Measure: Percentage of participants
At Month 12, n = 314,318,304,310 68.8 75.5 78.0 84.2
At Month 24, n = 292,291,276,287 75.7 77.3 80.1 88.2
12.Secondary Outcome
Title Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24
Hide Description A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.
Time Frame Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 314 318 304 310
Measure Type: Number
Unit of Measure: Percentage of participants
At Month 12, n = 314,318,304,310 62.4 64.5 60.9 68.7
At Month 24, n = 292,291,276,287 63.4 63.9 71.0 75.6
13.Secondary Outcome
Title Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24
Hide Description Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Time Frame From Baseline (Month 0) to Months 3, 6, 12, 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 272 278 276 278
Mean (Standard Deviation)
Unit of Measure: Percent change
At Month 3, n = 269,278,271,276 -49.5458  (30.8286) -46.4771  (26.5096) -50.2368  (28.1576) -57.3433  (33.9505)
At Month 6, n = 270,272,274,278 55.5900  (34.1672) -53.9838  (27.3557) -55.9614  (31.2801) -66.4354  (25.4762)
At Month 12, n = 272,276,276,267 -58.8244  (29.8250) -57.5363  (27.2271) -58.1046  (33.5095) -67.0703  (41.4563)
At Month 24, n = 221,215,211,235 -51.2360  (37.9032) -51.3040  (27.9844) -49.5567  (44.9707) 61.8822  (28.2309)
14.Secondary Outcome
Title Absolute Change In Baseline in Serum CTX to Months 12 and 24
Hide Description Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).
Time Frame From Baseline (Month 0) to Months 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 272 276 276 267
Mean (Standard Deviation)
Unit of Measure: ng/ml
Month 12, n = 272, 276, 276, 267 -0.323  (0.2292) -0.326  (0.2212) -0.340  (0.2287) -0.377  (0.2135)
Month 24, n = 221, 215, 211, 235 -0.285  (0.2052) -0.298  (0.1980) -0.312  (0.2398) -0.340  (0.2062)
15.Secondary Outcome
Title Number of Participants With Any Adverse Events and Serious Adverse Event
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 395 396 396 396
Measure Type: Number
Unit of Measure: Participants
Any AE 302 313 318 317
SAE 38 54 55 45
16.Secondary Outcome
Title Number Of Participants With Marked Laboratory Abnormalities
Hide Description Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 - 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 - 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment.
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description:
Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Overall Number of Participants Analyzed 390 390 385 385
Measure Type: Number
Unit of Measure: Participants
Hematocrit Low, n = 389,387,382,385 2 0 1 3
Hemoglobin High, n = 389,389,382,385 0 0 1 0
Hemoglobin Low, n = 389,389,382,385 3 3 6 3
WBC Low, n = 389,389,382,385 1 1 4 4
ALT (SGPT) High, n = 390,390,385,385 9 8 8 8
BUN High, n = 390,390,385,385 2 0 0 0
Creatinine High, n = 390,390,385,385 1 1 0 1
Chloride Low, n =3 89,390,385,384 3 3 0 3
Potassium Low, n = 389,390,385,383 0 0 0 1
Sodium High, n = 389,390,385,384 0 0 1 2
Sodium Low, n = 389,390,385,384 2 1 0 0
Calcium High, n = 390,390,385,385 1 0 0 1
Phosphate High, n = 390,390,385,385 4 3 3 1
Phosphate Low, n = 390,390,385,385 2 2 2 1
Time Frame 24 months
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the Safety Population, comprised of participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.
 
Arm/Group Title Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Hide Arm/Group Description Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day. Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day. Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
All-Cause Mortality
Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   38/395 (9.62%)   54/396 (13.64%)   55/396 (13.89%)   45/396 (11.36%) 
Blood and lymphatic system disorders         
Iron deficiency anaemia  1  1/395 (0.25%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Anaemia  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Cardiac disorders         
Cardiac failure  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  3/396 (0.76%) 
Myocardial ischemia  1  1/395 (0.25%)  1/396 (0.25%)  0/396 (0.00%)  2/396 (0.51%) 
Acute myocardial infarction  1  2/395 (0.51%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Angina pectoris  1  0/395 (0.00%)  1/396 (0.25%)  1/396 (0.25%)  1/396 (0.25%) 
Atrial fibrillation  1  1/395 (0.25%)  2/396 (0.51%)  0/396 (0.00%)  0/396 (0.00%) 
Coronary artery disease  1  1/395 (0.25%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Myocardial infarction  1  1/395 (0.25%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Tachycardia  1  0/395 (0.00%)  0/396 (0.00%)  2/396 (0.51%)  0/396 (0.00%) 
Acute coronary syndrome  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Angina unstable  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Cardiac failure congestive  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Cardiopulmonary failure  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Coronary artery stenosis  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Left ventricular failure  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Tachyarrhythmia  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Congenital, familial and genetic disorders         
Dermoid cyst of ovary  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Ear and labyrinth disorders         
Vestibular neuronitis  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Endocrine disorders         
Autoimmune thyroiditis  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Hyperparathyroidism  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Hyperparathyroidism primary  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Hyperthyroidism  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Eye disorders         
Cataract  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Diplopia  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Macular hole  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Gastrointestinal disorders         
Gastric ulcer  1  1/395 (0.25%)  1/396 (0.25%)  0/396 (0.00%)  1/396 (0.25%) 
Intestinal obstruction  1  1/395 (0.25%)  0/396 (0.00%)  1/396 (0.25%)  1/396 (0.25%) 
Melaena  1  2/395 (0.51%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Abdominal pain upper  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  1/396 (0.25%) 
Colonic polyp  1  1/395 (0.25%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Abdominal pain  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Appendicitis perforated  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Colitis ischaemic  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Colitis ulcerative  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Constipation  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Diarrhoea  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Duodenal ulcer  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Erosive duodenitis  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Gastric ulcer haemorrhage  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Gastritis haemorrhagic  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Gastrooesophageal reflux disease  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Pancreatitis  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Rectal haemorrhage  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Reflux gastritis  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Umbilical hernia  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
General disorders         
Chest pain  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  2/396 (0.51%) 
Adverse drug reaction  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Pyrexia  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Hepatobiliary disorders         
Cholelithiasis  1  1/395 (0.25%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Bile duct obstruction  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Liver disorder  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Infections and infestations         
Pneumonia  1  3/395 (0.76%)  1/396 (0.25%)  2/396 (0.51%)  2/396 (0.51%) 
Cellulitis  1  1/395 (0.25%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Lower respiratory tract Infection  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  1/396 (0.25%) 
Appendicitis  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Bronchial infection  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Chronic sinusitis  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Conjunctivitis bacterial  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Dacryocystitis infective  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Ear infection  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Ear infection viral  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Erysipelas  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Gangrene  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Hematoma infection  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Herpes zoster  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Laryngopharyngitis  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Postoperative abscess  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Pulmonary tuberculosis  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Pyelonephritis  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Salmonellosis  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Superinfection  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Superinfection lung  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Urosepsis  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Gastrointestinal haemorrhage  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  1/396 (0.25%) 
Injury, poisoning and procedural complications         
Concussion  1  1/395 (0.25%)  1/396 (0.25%)  1/396 (0.25%)  0/396 (0.00%) 
Femur fracture  1  0/395 (0.00%)  2/396 (0.51%)  0/396 (0.00%)  1/396 (0.25%) 
Cardiac pacemaker malfunction  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Foot fracture  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Head injury  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Humerus fracture  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Lower limb fracture  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Meniscus lesion  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Pain trauma activated  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Patella fracture  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Pelvic fracture  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Pubic rami fracture  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Radius fracture  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Rib fracture  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Spinal compression fracture  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Thoracic vertebral fracture  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Upper limb fracture  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Vascular graft occlusion  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Metabolism and nutrition disorders         
Diabetes mellitus  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Musculoskeletal and connective tissue disorders         
Localised osteoarthritis  1  0/395 (0.00%)  4/396 (1.01%)  1/396 (0.25%)  2/396 (0.51%) 
Arthralgia  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Bursitis  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Intervertebral disc protrusion  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Osteitis  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Osteoarthritis  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Polymyalgia rheumatica  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Pseudarthrosis  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Spondylosis  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Toe deformity  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer  1  1/395 (0.25%)  1/396 (0.25%)  1/396 (0.25%)  0/396 (0.00%) 
Colon cancer  1  1/395 (0.25%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Endometrial cancer  1  0/395 (0.00%)  1/396 (0.25%)  1/396 (0.25%)  0/396 (0.00%) 
Lung neoplasm malignant  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  1/396 (0.25%) 
Small cell lung cancer stage unspecified  1  0/395 (0.00%)  1/396 (0.25%)  1/396 (0.25%)  0/396 (0.00%) 
Benign neoplasm of bladder  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Breast cancer in situ  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Bronchial carcinoma  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Cholesteatoma  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Colon cancer metastatic  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Gammopathy  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Lipoma  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Meningioma  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Ovarian epithelial cancer  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Rectosigmoid cancer  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Thyroid neoplasm  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Nervous system disorders         
Syncope  1  0/395 (0.00%)  1/396 (0.25%)  2/396 (0.51%)  0/396 (0.00%) 
Cerebrovascular accident  1  0/395 (0.00%)  1/396 (0.25%)  1/396 (0.25%)  0/396 (0.00%) 
Vertebrobasilar insufficiency  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  1/396 (0.25%) 
Aphasia  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Dementia alzheimer's type  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Embolic stroke  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Facial palsy  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Facial paresis  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Haemorrhagic cerebral infarction  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Loss of consciousness  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Neuropathy peripheral  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Parkinson's disease  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Parkinsonism  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Sciatica  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Transient ischaemic attack  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Back pain  1  1/395 (0.25%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Psychiatric disorders         
Depression  1  1/395 (0.25%)  2/396 (0.51%)  2/396 (0.51%)  0/396 (0.00%) 
Anxiety  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Bipolar disorder  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Major depression  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Suicide attempt  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis  1  0/395 (0.00%)  1/396 (0.25%)  1/396 (0.25%)  1/396 (0.25%) 
Cystocele  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Renal colic  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Urethral syndrome  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Urinary incontinence  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Reproductive system and breast disorders         
Cervical polyp  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Endometrial hypertrophy  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Pelvic prolapse  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Uterine prolapse  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Vaginal prolapse  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism  1  0/395 (0.00%)  0/396 (0.00%)  2/396 (0.51%)  0/396 (0.00%) 
Chronic obstructive airways disease  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Cough  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Emphysema  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Hyperventilation  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Laryngeal polyp  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Pulmonary fibrosis  1  0/395 (0.00%)  0/396 (0.00%)  1/396 (0.25%)  0/396 (0.00%) 
Skin and subcutaneous tissue disorders         
Cutaneous lupus erythematosus  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Skin necrosis  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Surgical and medical procedures         
Cyst removal  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  0/396 (0.00%) 
Eventration procedure  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Vascular disorders         
Hypertension  1  1/395 (0.25%)  2/396 (0.51%)  0/396 (0.00%)  1/396 (0.25%) 
Aortic aneurysm  1  0/395 (0.00%)  1/396 (0.25%)  0/396 (0.00%)  1/396 (0.25%) 
Haematoma  1  0/395 (0.00%)  1/396 (0.25%)  1/396 (0.25%)  0/396 (0.00%) 
Hypotension  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Intermittent claudication  1  0/395 (0.00%)  0/396 (0.00%)  0/396 (0.00%)  1/396 (0.25%) 
Vascular pseudoaneurysm  1  1/395 (0.25%)  0/396 (0.00%)  0/396 (0.00%)  0/396 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ibandronate 2.5 mg Ibandronate 50/50 mg Ibandronate 100 mg Ibandronate 150 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   190/395 (48.10%)   190/396 (47.98%)   191/396 (48.23%)   182/396 (45.96%) 
Gastrointestinal disorders         
Nausea  1  20/395 (5.06%)  19/396 (4.80%)  18/396 (4.55%)  25/396 (6.31%) 
Diarrhoea  1  21/395 (5.32%)  20/396 (5.05%)  16/396 (4.04%)  19/396 (4.80%) 
Dyspepsia  1  28/395 (7.09%)  29/396 (7.32%)  37/396 (9.34%)  26/396 (6.57%) 
Infections and infestations         
Nasopharyngitis  1  38/395 (9.62%)  23/396 (5.81%)  27/396 (6.82%)  24/396 (6.06%) 
Influenza  1  25/395 (6.33%)  31/396 (7.83%)  18/396 (4.55%)  26/396 (6.57%) 
Urinary tract infection  1  15/395 (3.80%)  18/396 (4.55%)  15/396 (3.79%)  19/396 (4.80%) 
Bronchitis  1  20/395 (5.06%)  10/396 (2.53%)  18/396 (4.55%)  12/396 (3.03%) 
Metabolism and nutrition disorders         
Hypercholesterolaemia  1  21/395 (5.32%)  9/396 (2.27%)  16/396 (4.04%)  18/396 (4.55%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  24/395 (6.08%)  39/396 (9.85%)  35/396 (8.84%)  27/396 (6.82%) 
Back pain  1  25/395 (6.33%)  36/396 (9.09%)  36/396 (9.09%)  28/396 (7.07%) 
Pain in extremity  1  9/395 (2.28%)  14/396 (3.54%)  13/396 (3.28%)  20/396 (5.05%) 
Localised osteoarthritis  1  10/395 (2.53%)  12/396 (3.03%)  12/396 (3.03%)  19/396 (4.80%) 
Vascular disorders         
Hypertension  1  46/395 (11.65%)  43/396 (10.86%)  47/396 (11.87%)  41/396 (10.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (7.1)
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 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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
EMail: global.trial_information@roche.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048061    
Other Study ID Numbers: BM16549
First Submitted: October 24, 2002
First Posted: October 25, 2002
Results First Submitted: February 5, 2016
Results First Posted: May 30, 2016
Last Update Posted: March 29, 2018