Trial Outcomes & Findings for A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva (NCT NCT00081653)
NCT ID: NCT00081653
Last Updated: 2017-07-14
Results Overview
Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
719 participants
Primary outcome timeframe
Baseline and Months 12, 24 and 36
Results posted on
2017-07-14
Participant Flow
Patients were recruited from 31 centers over the period of 18 May 2004 to 28 November 2007.
Eligible for the study were patients having completed Study BM16549 (NCT00081653) and who had complied with the monthly regimen for 75 percent (%) or more.
Participant milestones
| Measure |
Ibandronate 100 Milligrams (mg)
100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Overall Study
STARTED
|
358
|
361
|
|
Overall Study
COMPLETED
|
311
|
324
|
|
Overall Study
NOT COMPLETED
|
47
|
37
|
Reasons for withdrawal
| Measure |
Ibandronate 100 Milligrams (mg)
100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Overall Study
Adverse Event
|
23
|
17
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
|
Overall Study
Refused Treatment
|
18
|
14
|
|
Overall Study
Low bone mineral density
|
1
|
0
|
|
Overall Study
Bone loss
|
2
|
0
|
|
Overall Study
Participant leaving country
|
1
|
0
|
|
Overall Study
Loss of bone mass
|
0
|
2
|
Baseline Characteristics
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
Baseline characteristics by cohort
| Measure |
Ibandronate 100 mg
n=358 Participants
100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
n=361 Participants
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
Total
n=719 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 6.55 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
67.7 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
358 Participants
n=5 Participants
|
361 Participants
n=7 Participants
|
719 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI (kg/m^2)
|
25.87 kg/m^2
STANDARD_DEVIATION 4.957 • n=5 Participants
|
26.04 kg/m^2
STANDARD_DEVIATION 3.976 • n=7 Participants
|
25.96 kg/m^2
STANDARD_DEVIATION 4.489 • n=5 Participants
|
|
Race, Customized
Caucasian/White
|
341 participants
n=5 Participants
|
338 participants
n=7 Participants
|
679 participants
n=5 Participants
|
|
Race, Customized
Black
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race, Customized
Oriental
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race, Customized
Hispanic
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Race, Customized
Other
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Months 12, 24 and 36Population: ITT population; number (n) equals (=) number of participants analyzed at the specified visit.
Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm\^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Outcome measures
| Measure |
Ibandronate 100 mg
n=347 Participants
100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
n=346 Participants
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Baseline (n=347,346)
|
0.7916 g/cm^2
Standard Deviation 0.0814
|
0.7977 g/cm^2
Standard Deviation 0.0791
|
|
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Month 12 (n=347,346)
|
0.7977 g/cm^2
Standard Deviation 0.0831
|
0.8069 g/cm^2
Standard Deviation 0.0819
|
|
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Change from Baseline at Month 12 (n=346,343)
|
0.0061 g/cm^2
Standard Deviation 0.0293
|
0.0097 g/cm^2
Standard Deviation 0.0289
|
|
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Month 24 (n=323,336)
|
0.8048 g/cm^2
Standard Deviation 0.0861
|
0.8111 g/cm^2
Standard Deviation 0.0852
|
|
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Change from Baseline at Month 24 (n=322,333)
|
0.0131 g/cm^2
Standard Deviation 0.0332
|
0.0140 g/cm^2
Standard Deviation 0.0356
|
|
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Month 36 (n=308,320)
|
0.8090 g/cm^2
Standard Deviation 0.0916
|
0.8155 g/cm^2
Standard Deviation 0.0892
|
|
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD
Change from Baseline at Month 36 (n=307, 318)
|
0.0172 g/cm^2
Standard Deviation 0.0382
|
0.0194 g/cm^2
Standard Deviation 0.0383
|
PRIMARY outcome
Timeframe: Baseline and Months 12, 24 and 36Population: ITT population: n = number of participants analyzed for the given parameter at the specified visit.
BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae \[L2-L4\] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 \[NCT00081653\]).
Outcome measures
| Measure |
Ibandronate 100 mg
n=346 Participants
100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
n=343 Participants
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
Change from Baseline at Month 12 (n=346,343)
|
0.8348 percent change
Standard Deviation 3.8118
|
1.2550 percent change
Standard Deviation 3.6402
|
|
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
Change from Baseline at Month 24 (n=322,333)
|
1.6921 percent change
Standard Deviation 4.2385
|
1.7865 percent change
Standard Deviation 4.5058
|
|
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)
Change from Baseline at Month 36 (n=307,318)
|
2.1794 percent change
Standard Deviation 4.9176
|
2.4322 percent change
Standard Deviation 4.8146
|
SECONDARY outcome
Timeframe: Baseline and 12, 24 and 36 monthsPopulation: ITT Population; n = number of participants analyzed for the given parameter at the specified visit.
BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
Outcome measures
| Measure |
Ibandronate 100 mg
n=347 Participants
100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
n=348 Participants
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Absolute Change From Baseline in Mean Total Hip BMD
Baseline (n=345,348)
|
0.7680 g/cm^2
Standard Deviation 0.1093
|
0.7862 g/cm^2
Standard Deviation 0.1112
|
|
Absolute Change From Baseline in Mean Total Hip BMD
Month 12 (n=347,346)
|
0.7669 g/cm^2
Standard Deviation 0.1097
|
0.7888 g/cm^2
Standard Deviation 0.1116
|
|
Absolute Change From Baseline in Mean Total Hip BMD
Change from Baseline at Month 12 (n=344,345)
|
-0.0004 g/cm^2
Standard Deviation 0.0204
|
0.0025 g/cm^2
Standard Deviation 0.0200
|
|
Absolute Change From Baseline in Mean Total Hip BMD
Month 24 (n=322,336)
|
0.7686 g/cm^2
Standard Deviation 0.1104
|
0.7882 g/cm^2
Standard Deviation 0.1124
|
|
Absolute Change From Baseline in Mean Total Hip BMD
Change from Baseline at Month 24 (n=319,335)
|
-0.0010 g/cm^2
Standard Deviation 0.0227
|
0.0031 g/cm^2
Standard Deviation 0.0214
|
|
Absolute Change From Baseline in Mean Total Hip BMD
Month 36 (n=301,321)
|
0.7663 g/cm^2
Standard Deviation 0.1133
|
0.7834 g/cm^2
Standard Deviation 0.1128
|
|
Absolute Change From Baseline in Mean Total Hip BMD
Change from Baseline at Month 36 (n=298,320)
|
-0.0061 g/cm^2
Standard Deviation 0.0254
|
-0.0030 g/cm^2
Standard Deviation 0.0252
|
SECONDARY outcome
Timeframe: Baseline, 12, 24 and 36 monthsPopulation: ITT Population; n = number of participants analyzed for the given parameter at the specified visit.
BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).
Outcome measures
| Measure |
Ibandronate 100 mg
n=344 Participants
100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
n=345 Participants
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Relative Percent Change From Baseline in Mean Total Hip BMD
Change from Baseline at Month 12 (n=344,345)
|
-0.0169 percent change in BMD
Standard Deviation 2.8582
|
0.3459 percent change in BMD
Standard Deviation 2.5849
|
|
Relative Percent Change From Baseline in Mean Total Hip BMD
Change from Baseline at Month 24 (n=319,335)
|
-0.1092 percent change in BMD
Standard Deviation 3.1040
|
0.4378 percent change in BMD
Standard Deviation 2.8062
|
|
Relative Percent Change From Baseline in Mean Total Hip BMD
Change from Baseline at Month 36 (n=298,320)
|
-0.8045 percent change in BMD
Standard Deviation 3.3448
|
-0.3496 percent change in BMD
Standard Deviation 3.3254
|
SECONDARY outcome
Timeframe: Baseline, 6, 12, 24 and 36 monthsPopulation: ITT population; n = number of participants analyzed for the given parameter at the specified visit.
CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
Outcome measures
| Measure |
Ibandronate 100 mg
n=57 Participants
100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
n=68 Participants
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Absolute Change From Baseline of Trough Serum CTX
Baseline (n= 56,68)
|
0.232 ng/mL
Standard Deviation 0.1520
|
0.219 ng/mL
Standard Deviation 0.1799
|
|
Absolute Change From Baseline of Trough Serum CTX
Month 6 Postdose (n=56,68)
|
0.176 ng/mL
Standard Deviation 0.1826
|
0.126 ng/mL
Standard Deviation 0.1222
|
|
Absolute Change From Baseline of Trough Serum CTX
Change from Baseline at Month 6 Postdose (n=55,67)
|
-0.055 ng/mL
Standard Deviation 0.1307
|
-0.093 ng/mL
Standard Deviation 0.1510
|
|
Absolute Change From Baseline of Trough Serum CTX
Month 12 (n=57,67)
|
0.279 ng/mL
Standard Deviation 0.1617
|
0.208 ng/mL
Standard Deviation 0.1073
|
|
Absolute Change From Baseline of Trough Serum CTX
Change from Baseline at Month 12 (n=56,67)
|
0.048 ng/mL
Standard Deviation 0.1303
|
-0.011 ng/mL
Standard Deviation 0.1406
|
|
Absolute Change From Baseline of Trough Serum CTX
Month 24 (n=54,65)
|
0.309 ng/mL
Standard Deviation 0.1406
|
0.266 ng/mL
Standard Deviation 0.1548
|
|
Absolute Change From Baseline of Trough Serum CTX
Change from Baseline at Month 24 (n=53,65)
|
0.088 ng/mL
Standard Deviation 0.1203
|
0.048 ng/mL
Standard Deviation 0.1607
|
|
Absolute Change From Baseline of Trough Serum CTX
Month 36 (n=51,60)
|
0.410 ng/mL
Standard Deviation 0.1805
|
0.380 ng/mL
Standard Deviation 0.2036
|
|
Absolute Change From Baseline of Trough Serum CTX
Change from Baseline at Month 12 (n=50,60)
|
0.205 ng/mL
Standard Deviation 0.1396
|
0.174 ng/mL
Standard Deviation 0.1549
|
SECONDARY outcome
Timeframe: Baseline, 6,12, 24 and 36 monthsPopulation: ITT population; n = number of participants analyzed for the given parameter at the specified visit.
CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.
Outcome measures
| Measure |
Ibandronate 100 mg
n=56 Participants
100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
n=68 Participants
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Relative Percent Change From Baseline of Trough Serum CTX
Baseline (n=56,68)
|
0.232 percent change
Standard Deviation 0.1520
|
0.219 percent change
Standard Deviation 0.1799
|
|
Relative Percent Change From Baseline of Trough Serum CTX
Month 6 Postdose (n=56, 67)
|
0.176 percent change
Standard Deviation 0.1826
|
33.109 percent change
Standard Deviation 40.3544
|
|
Relative Percent Change From Baseline of Trough Serum CTX
Change from Baseline at Month 6 Postdose (n=55,67)
|
-24.622 percent change
Standard Deviation 43.4212
|
-33.109 percent change
Standard Deviation 40.3544
|
|
Relative Percent Change From Baseline of Trough Serum CTX
Month 12 (n=57,67)
|
0.279 percent change
Standard Deviation 0.1617
|
0.208 percent change
Standard Deviation 0.1073
|
|
Relative Percent Change From Baseline of Trough Serum CTX
Change from Baseline at Month 12 (n=56,67)
|
31.121 percent change
Standard Deviation 58.9832
|
25.125 percent change
Standard Deviation 86.5607
|
|
Relative Percent Change From Baseline of Trough Serum CTX
Month 24 (n=54,65)
|
0.309 percent change
Standard Deviation 0.1406
|
0.266 percent change
Standard Deviation 0.1548
|
|
Relative Percent Change From Baseline of Trough Serum CTX
Change from Baseline at Month 24 (n=53,65)
|
58.657 percent change
Standard Deviation 65.3128
|
53.704 percent change
Standard Deviation 74.9810
|
|
Relative Percent Change From Baseline of Trough Serum CTX
Month 36 (51,60)
|
0.410 percent change
Standard Deviation 0.1805
|
0.380 percent change
Standard Deviation 0.2036
|
|
Relative Percent Change From Baseline of Trough Serum CTX
Change from Baseline at Month 36 (n=50,60)
|
121.106 percent change
Standard Deviation 97.9878
|
138.502 percent change
Standard Deviation 125.7590
|
Adverse Events
Ibandronate 100 mg
Serious events: 68 serious events
Other events: 187 other events
Deaths: 0 deaths
Ibandronate 150 mg
Serious events: 70 serious events
Other events: 185 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibandronate 100 mg
n=358 participants at risk
100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
n=361 participants at risk
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Infections and infestations
Wound infection
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Vascular disorders
Aortic aneurysm
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Vascular disorders
Deep vein thrombosis
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
1.1%
4/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.84%
3/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.83%
3/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
5/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
1.4%
5/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Atrial fibrillation
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Atrial flutter
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Cardiac arrest
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Cardiac fibrillation
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medullary thyroid cancer
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal carcinoma
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Signet-ring cell carcinoma
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
4/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
1.4%
5/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.84%
3/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.55%
2/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Pneumonia
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.55%
2/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Diverticulitis
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Appendicitis
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Cystitis
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Infected skin ulcer
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Tetanus
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Ureteritis
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Vascular disorders
Hypertension
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.55%
2/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Vascular disorders
Thrombophlebitis
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Eye disorders
Cataract
|
0.84%
3/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.55%
2/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Eye disorders
Keratoconus
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Eye disorders
Entropion
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Eye disorders
Retinal detachment
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.83%
3/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Reproductive system and breast disorders
Cervix disorder
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Reproductive system and breast disorders
Vaginal disorder
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Nervous system disorders
Facial paresis
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Nervous system disorders
Hemiparesis
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.55%
2/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary sarcoidosis
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Metabolism and nutrition disorders
Central obesity
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
General disorders
Chest pain
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
General disorders
General physical health deterioration
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
General disorders
Oedema peripheral
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.56%
2/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Endocrine disorders
Goitre
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Endocrine disorders
Hyperthyroidism
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Congenital, familial and genetic disorders
Fibrous dysplasia of bone
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Investigations
Weight decreased
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Psychiatric disorders
Confusional state
|
0.28%
1/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.00%
0/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Surgical and medical procedures
Diabetes mellitus management
|
0.00%
0/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
0.28%
1/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
Other adverse events
| Measure |
Ibandronate 100 mg
n=358 participants at risk
100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
|
Ibandronate 150 mg
n=361 participants at risk
150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.8%
46/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
11.1%
40/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Urinary tract infection
|
6.1%
22/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
7.5%
27/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Bronchitis
|
6.7%
24/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
5.8%
21/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Infections and infestations
Influenza
|
6.1%
22/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
4.2%
15/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.9%
32/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
8.6%
31/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
32/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
10.0%
36/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.3%
19/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
6.6%
24/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
18/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
4.2%
15/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Vascular disorders
Hypertension
|
11.7%
42/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
13.6%
49/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.4%
30/358 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
6.4%
23/361 • Adverse events were recorded from the date of informed consent until 15 days after the final visit at 36 months.
|
Additional Information
Clinical Trials Study Director
Hoffmann-La Roche
Phone: +1 973 235 5000
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place