Trial Outcomes & Findings for A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease. (NCT NCT00503113)
NCT ID: NCT00503113
Last Updated: 2011-06-17
Results Overview
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
801 participants
Primary outcome timeframe
Baseline and 9 months
Results posted on
2011-06-17
Participant Flow
Total 801 participants randomized. Of the randomized patients, 263 who received at least one dose of ibandronate as an injection, 263 who received at least one dose of ibandronate as an infusion and 267 patients who received at least one dose of alendronate had at least one post-baseline assessment and were included in the safety analysis.
Participant milestones
| Measure |
Ibandronate 3 mg Injection
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Overall Study
STARTED
|
268
|
264
|
269
|
|
Overall Study
Intent to Treat Population (ITT)
|
262
|
261
|
268
|
|
Overall Study
Per Protocol Population (PP)
|
246
|
243
|
241
|
|
Overall Study
Safety Population
|
263
|
263
|
267
|
|
Overall Study
COMPLETED
|
235
|
236
|
241
|
|
Overall Study
NOT COMPLETED
|
33
|
28
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Baseline characteristics by cohort
| Measure |
Ibandronate 3 mg Injection
n=263 Participants
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=263 Participants
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=267 Participants
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
Total
n=793 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
71.7 years
STANDARD_DEVIATION 6.77 • n=5 Participants
|
71.5 years
STANDARD_DEVIATION 5.89 • n=7 Participants
|
71.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 6.32 • n=4 Participants
|
|
Sex: Female, Male
Female
|
263 Participants
n=5 Participants
|
263 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
793 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 9 monthsPopulation: Per Protocol (PP) Population
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.
Outcome measures
| Measure |
Ibandronate 3 mg Injection
n=246 Participants
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=243 Participants
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=241 Participants
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
Baseline
|
72.5 mL/min
Standard Deviation 18.25
|
71.5 mL/min
Standard Deviation 18.07
|
70.5 mL/min
Standard Deviation 16.67
|
|
Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
Change from baseline at 9 months (n=233,232,225)
|
-1.3 mL/min
Standard Deviation 7.14
|
-0.5 mL/min
Standard Deviation 7.86
|
-1.6 mL/min
Standard Deviation 5.89
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: PP Population
Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault \[CG\] formula) after 9 months (or 40 weeks) of treatment.
Outcome measures
| Measure |
Ibandronate 3 mg Injection
n=246 Participants
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=243 Participants
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=241 Participants
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
Baseline
|
65.0 mL/min
Standard Deviation 19.37
|
62.9 mL/min
Standard Deviation 18.22
|
62.0 mL/min
Standard Deviation 16.67
|
|
Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
Change from Baseline at 9 months (N=233,232,225)
|
-1.6 mL/min
Standard Deviation 5.89
|
-1.0 mL/min
Standard Deviation 6.44
|
-1.9 mL/min
Standard Deviation 4.84
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: PP Population
Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Outcome measures
| Measure |
Ibandronate 3 mg Injection
n=246 Participants
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=243 Participants
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=241 Participants
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
Baseline
|
72.5 mL/min
Standard Deviation 18.25
|
71.5 mL/min
Standard Deviation 18.07
|
70.5 mL/min
Standard Deviation 16.67
|
|
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
Relative Change at 9 month (n= 233, 232, 225)
|
-1.4 mL/min
Standard Deviation 10.01
|
-0.2 mL/min
Standard Deviation 10.73
|
-2.1 mL/min
Standard Deviation 8.64
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: PP Population
Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Outcome measures
| Measure |
Ibandronate 3 mg Injection
n=246 Participants
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=243 Participants
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=241 Participants
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Relative Change From Baseline in Actual GFR (Using CG Formula)
Baseline
|
65.0 mL/min
Standard Deviation 19.37
|
62.9 mL/min
Standard Deviation 18.22
|
62.0 mL/min
Standard Deviation 16.76
|
|
Relative Change From Baseline in Actual GFR (Using CG Formula)
Relative Change at 9 month (n=233,232,225)
|
-2.3 mL/min
Standard Deviation 9.22
|
-1.3 mL/min
Standard Deviation 9.55
|
-2.8 mL/min
Standard Deviation 7.97
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: PP Population
Outcome measures
| Measure |
Ibandronate 3 mg Injection
n=246 Participants
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=243 Participants
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=241 Participants
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Absolute Change From Baseline in Mean Serum Creatinine.
Baseline
|
0.8 mg/dL
Standard Deviation 0.17
|
0.8 mg/dL
Standard Deviation 0.16
|
0.8 mg/dL
Standard Deviation 0.16
|
|
Absolute Change From Baseline in Mean Serum Creatinine.
Change from Baseline at 9 months (n=233,232,225)
|
0.0 mg/dL
Standard Deviation 0.08
|
0.0 mg/dL
Standard Deviation 0.08
|
0.0 mg/dL
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: PP Population
Outcome measures
| Measure |
Ibandronate 3 mg Injection
n=246 Participants
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=243 Participants
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=241 Participants
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Relative Change From Baseline in Mean Serum Creatinine.
Baseline
|
0.8 mg/dL
Standard Deviation 0.17
|
0.8 mg/dL
Standard Deviation 0.16
|
0.8 mg/dL
Standard Deviation 0.16
|
|
Relative Change From Baseline in Mean Serum Creatinine.
Relative Change at 9 months (n=233,232,225)
|
1.7 mg/dL
Standard Deviation 8.87
|
0.8 mg/dL
Standard Deviation 8.87
|
2.2 mg/dL
Standard Deviation 8.06
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: PP Population
Outcome measures
| Measure |
Ibandronate 3 mg Injection
n=246 Participants
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=243 Participants
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=241 Participants
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Change from Baseline at 9 months (n=233,232,225)
|
-0.8 mg/g
Standard Deviation 18.54
|
0.5 mg/g
Standard Deviation 14.70
|
1.4 mg/g
Standard Deviation 22.99
|
|
Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Baseline
|
16.0 mg/g
Standard Deviation 17.30
|
14.1 mg/g
Standard Deviation 15.22
|
16.1 mg/g
Standard Deviation 19.11
|
SECONDARY outcome
Timeframe: Baseline and 9 monthsPopulation: PP Population
The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.
Outcome measures
| Measure |
Ibandronate 3 mg Injection
n=246 Participants
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=243 Participants
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=241 Participants
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Baseline
|
16.0 mg/g
Standard Deviation 17.30
|
14.1 mg/g
Standard Deviation 15.22
|
16.1 mg/g
Standard Deviation 19.11
|
|
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Relative Change at 9 month (n=233,232,225)
|
21.6 mg/g
Standard Deviation 120.98
|
15.6 mg/g
Standard Deviation 62.32
|
28.3 mg/g
Standard Deviation 116.71
|
Adverse Events
Ibandronate 3 mg Injection
Serious events: 19 serious events
Other events: 196 other events
Deaths: 0 deaths
Ibandronate 3 mg Infusion
Serious events: 15 serious events
Other events: 190 other events
Deaths: 0 deaths
Alendronate 70 mg Oral
Serious events: 13 serious events
Other events: 191 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibandronate 3 mg Injection
n=263 participants at risk
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=263 participants at risk
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=267 participants at risk
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.1%
3/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.5%
4/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
1.1%
3/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Injury, poisoning and procedural complications
Multiple Drug Overdose Accidental
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.76%
2/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Cardiac disorders
Conduction Disorder
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Cardiac disorders
Myocardial Infarction
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Pneumonia
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Abdominal Abscess
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Haematochezia
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Peptic Ulcer Perforation
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.76%
2/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.75%
2/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.76%
2/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage II
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Nervous system disorders
Dizziness
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Nervous system disorders
Hemiparesis
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Nervous system disorders
Ischemic Stroke
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Nervous system disorders
Ruptured Cerebral Aneurysm
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Nervous system disorders
Senile Dementia
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Vascular disorders
Hypertensive Crisis
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Vascular disorders
Temporal Arteritis
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Blood and lymphatic system disorders
Autoimmune Thrombocytopenia
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Reproductive system and breast disorders
Breast Mass
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
Other adverse events
| Measure |
Ibandronate 3 mg Injection
n=263 participants at risk
Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
|
Ibandronate 3 mg Infusion
n=263 participants at risk
Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
|
Alendronate 70 mg Oral
n=267 participants at risk
Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
14.1%
37/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
12.2%
32/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
11.2%
30/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.9%
26/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
11.0%
29/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
9.4%
25/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
22/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
10.6%
28/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
10.1%
27/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Vascular disorders
Hypertension
|
8.7%
23/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
10.6%
28/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
6.0%
16/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.4%
22/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
8.7%
23/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
7.9%
21/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.4%
22/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
5.3%
14/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.2%
6/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
7.2%
19/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
5.7%
15/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.6%
7/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Nervous system disorders
Dizziness
|
7.2%
19/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.6%
12/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.4%
9/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.2%
11/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
7.1%
19/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
14/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.9%
5/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
6.4%
17/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Nervous system disorders
Headache
|
5.3%
14/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
5.7%
15/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.2%
6/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspepsia
|
1.9%
5/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.2%
11/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
6.4%
17/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
12/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.6%
12/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.0%
8/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Bronchitis
|
3.8%
10/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.2%
11/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.7%
10/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.4%
9/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.9%
13/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
General disorders
Influenza Like Illness
|
5.7%
15/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
5.3%
14/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
10/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.8%
10/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.7%
10/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
General disorders
Oedema Peripheral
|
4.6%
12/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.3%
6/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.5%
12/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Urinary Tract Infection
|
3.4%
9/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.8%
10/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.1%
11/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
6/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.9%
13/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Psychiatric disorders
Anxiety
|
1.9%
5/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.8%
10/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.7%
10/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Psychiatric disorders
Depression
|
4.2%
11/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.0%
8/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.9%
5/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Injury, poisoning and procedural complications
Fall
|
4.9%
13/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.0%
8/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.1%
3/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
3/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.2%
11/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.4%
9/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
8/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.4%
9/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.9%
5/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Constipation
|
3.0%
8/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.4%
9/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.9%
5/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Metabolism and nutrition disorders
Dyslipidemia
|
0.76%
2/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.0%
8/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.7%
10/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
5/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.0%
8/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.6%
7/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.9%
5/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.0%
8/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
8/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.5%
4/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Nervous system disorders
Sciatica
|
2.3%
6/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.9%
5/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.3%
6/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.5%
4/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
General disorders
Pain
|
2.3%
6/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.4%
9/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.75%
2/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.75%
2/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
0.76%
2/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.1%
3/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
4.1%
11/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Labyrinthitis
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.1%
3/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.2%
6/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.3%
6/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.9%
5/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.9%
5/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
2.3%
6/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.00%
0/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
3.0%
8/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
3/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.5%
4/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.6%
7/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Infections and infestations
Sinusitis
|
1.5%
4/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
1.5%
4/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.2%
6/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
5/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
2.3%
6/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.75%
2/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
|
Gastrointestinal disorders
Haemorrhoids
|
2.7%
7/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.38%
1/263 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
0.37%
1/267 • AEs are considered to have occurred 'On treatment', defined as first dose and up 106 days after last dose if patient's actual treatment is ibandronate, or up to 22 days after last dose if patient's actual treatment is the alendronate.
|
Additional Information
Medical Communications
Hoffman-LaRoche
Phone: 800-821-8590
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- Principal investigator is a sponsor employee
- Publication restrictions are in place