Trial Outcomes & Findings for Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis (NCT NCT00619957)
NCT ID: NCT00619957
Last Updated: 2011-10-28
Results Overview
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
285 participants
Primary outcome timeframe
Baseline to 24 Months/Endpoint
Results posted on
2011-10-28
Participant Flow
Recruitment began on 03 Jun 2002.
Participant milestones
| Measure |
Placebo
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Month 24 Double-Blind
STARTED
|
93
|
192
|
|
Month 24 Double-Blind
Intent to Treat (ITT Population)
|
93
|
191
|
|
Month 24 Double-Blind
COMPLETED
|
75
|
175
|
|
Month 24 Double-Blind
NOT COMPLETED
|
18
|
17
|
|
Month 48 Open-Label
STARTED
|
67
|
151
|
|
Month 48 Open-Label
COMPLETED
|
55
|
134
|
|
Month 48 Open-Label
NOT COMPLETED
|
12
|
17
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Month 24 Double-Blind
Adverse Event
|
9
|
7
|
|
Month 24 Double-Blind
Protocol Violation
|
1
|
0
|
|
Month 24 Double-Blind
Withdrawal by Subject
|
7
|
9
|
|
Month 24 Double-Blind
Lost to Follow-up
|
1
|
0
|
|
Month 24 Double-Blind
Did not take any study medication
|
0
|
1
|
|
Month 48 Open-Label
Adverse Event
|
4
|
4
|
|
Month 48 Open-Label
Lost to Follow-up
|
2
|
4
|
|
Month 48 Open-Label
Withdrawal by Subject
|
6
|
9
|
Baseline Characteristics
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
Baseline characteristics by cohort
| Measure |
Placebo
n=93 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=192 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 65 years
|
49 participants
n=93 Participants
|
120 participants
n=4 Participants
|
169 participants
n=27 Participants
|
|
Age, Customized
Between 65 and <75 years
|
34 participants
n=93 Participants
|
51 participants
n=4 Participants
|
85 participants
n=27 Participants
|
|
Age, Customized
>=75 years
|
10 participants
n=93 Participants
|
20 participants
n=4 Participants
|
30 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
93 Participants
n=93 Participants
|
192 Participants
n=4 Participants
|
285 Participants
n=27 Participants
|
|
Region of Enrollment
Australia
|
3 participants
n=93 Participants
|
7 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=93 Participants
|
24 participants
n=4 Participants
|
36 participants
n=27 Participants
|
|
Region of Enrollment
Czech Republic
|
5 participants
n=93 Participants
|
12 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Region of Enrollment
France
|
2 participants
n=93 Participants
|
7 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Region of Enrollment
Hungary
|
11 participants
n=93 Participants
|
20 participants
n=4 Participants
|
31 participants
n=27 Participants
|
|
Region of Enrollment
Lebanon
|
2 participants
n=93 Participants
|
4 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=93 Participants
|
7 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
35 participants
n=93 Participants
|
73 participants
n=4 Participants
|
108 participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
32 participants
n=4 Participants
|
49 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 Months/EndpointPopulation: ITT Population, LOCF (Last Observation Carried Forward)
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Outcome measures
| Measure |
Placebo
n=87 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=188 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.
|
1.22 Percent Change
Interval 0.23 to 2.21
|
5.75 Percent Change
Interval 5.0 to 6.5
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Outcome measures
| Measure |
Placebo
n=86 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=184 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.
|
1.03 Percent Change
Interval 0.2 to 1.87
|
3.60 Percent Change
Interval 2.96 to 4.24
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Outcome measures
| Measure |
Placebo
n=83 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=183 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.
|
1.42 Percent Change
Interval 0.51 to 2.34
|
4.60 Percent Change
Interval 3.91 to 5.29
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=172 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.
|
1.40 Percent Change
Interval 0.39 to 2.41
|
5.98 Percent Change
Interval 5.22 to 6.73
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Outcome measures
| Measure |
Placebo
n=84 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=184 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.
|
0.76 Percent Change
Interval 0.22 to 1.31
|
1.16 Percent Change
Interval 0.75 to 1.58
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Outcome measures
| Measure |
Placebo
n=83 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=183 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.
|
0.74 Percent Change
Interval 0.18 to 1.29
|
1.38 Percent Change
Interval 0.97 to 1.8
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=172 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.
|
0.06 Percent Change
Interval -0.6 to 0.73
|
1.76 Percent Change
Interval 1.26 to 2.26
|
SECONDARY outcome
Timeframe: Baseline to 24 Months/EndpointPopulation: ITT Population, LOCF (Last Observation Carried Forward)
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).
Outcome measures
| Measure |
Placebo
n=87 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=188 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.
|
0.24 Percent Change
Interval -0.41 to 0.89
|
1.71 Percent Change
Interval 1.21 to 2.2
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Outcome measures
| Measure |
Placebo
n=84 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=184 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.
|
0.48 Percent Change
Interval -0.32 to 1.27
|
0.98 Percent Change
Interval 0.37 to 1.58
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Outcome measures
| Measure |
Placebo
n=83 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=183 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.
|
0.62 Percent Change
Interval -0.18 to 1.43
|
1.49 Percent Change
Interval 0.88 to 2.1
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=172 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.
|
0.42 Percent Change
Interval -0.43 to 1.27
|
1.65 Percent Change
Interval 1.02 to 2.29
|
SECONDARY outcome
Timeframe: Baseline to 24 Months/EndpointPopulation: ITT Population, LOCF (Last Observation Carried Forward)
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD\[lunar\]) - 0.008
Outcome measures
| Measure |
Placebo
n=87 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=188 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.
|
0.53 Percent Change
Interval -0.28 to 1.35
|
1.59 Percent Change
Interval 0.97 to 2.21
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Outcome measures
| Measure |
Placebo
n=84 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=184 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.
|
0.67 Percent Change
Interval -0.04 to 1.38
|
1.24 Percent Change
Interval 0.71 to 1.78
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Outcome measures
| Measure |
Placebo
n=83 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=183 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.
|
0.81 Percent Change
Interval 0.03 to 1.59
|
1.89 Percent Change
Interval 1.3 to 2.48
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=172 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.
|
0.52 Percent Change
Interval -0.37 to 1.41
|
2.83 Percent Change
Interval 2.16 to 3.49
|
SECONDARY outcome
Timeframe: Baseline to 24 Months/EndpointPopulation: ITT Population, LOCF (Last Observation Carried Forward)
DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Outcome measures
| Measure |
Placebo
n=87 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=188 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.
|
0.57 Percent Change
Interval -0.29 to 1.44
|
2.73 Percent Change
Interval 2.07 to 3.38
|
SECONDARY outcome
Timeframe: Baseline to Month 3Population: ITT Population
Outcome measures
| Measure |
Placebo
n=82 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=180 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.
|
-14.56 Percent Change
Interval -21.87 to -7.26
|
-58.16 Percent Change
Interval -63.64 to -52.68
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT Population
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=178 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in CTx, Month 6, ITT Population.
|
-13.72 Percent Change
Interval -25.91 to -1.52
|
-58.44 Percent Change
Interval -67.63 to -49.25
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=175 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in CTx, Month 12, ITT Population.
|
-19.12 Percent Change
Interval -31.66 to -6.58
|
-61.46 Percent Change
Interval -70.8 to -52.11
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=163 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in CTx, Month 24, ITT Population.
|
9.28 Percent Change
Interval -2.6 to 21.16
|
-37.27 Percent Change
Interval -46.06 to -28.48
|
SECONDARY outcome
Timeframe: Baseline to 24 Months/EndpointPopulation: ITT Population, LOCF (Last Observation Carried Forward)
Outcome measures
| Measure |
Placebo
n=83 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=183 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.
|
6.39 Percent Change
Interval -4.55 to 17.34
|
-38.76 Percent Change
Interval -46.97 to -30.54
|
SECONDARY outcome
Timeframe: Baseline to Month 3Population: ITT Population
Outcome measures
| Measure |
Placebo
n=84 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=181 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.
|
-17.41 Percent Change
Interval -24.38 to -10.43
|
-33.28 Percent Change
Interval -38.58 to -27.98
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT Population
Outcome measures
| Measure |
Placebo
n=83 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=180 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.
|
-7.98 Percent Change
Interval -16.33 to 0.38
|
-29.97 Percent Change
Interval -36.34 to -23.6
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=176 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.
|
-16.46 Percent Change
Interval -24.55 to -8.37
|
-38.42 Percent Change
Interval -44.45 to -32.39
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
Outcome measures
| Measure |
Placebo
n=75 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=167 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.
|
-22.27 Percent Change
Interval -30.69 to -13.85
|
-37.38 Percent Change
Interval -43.69 to -31.07
|
SECONDARY outcome
Timeframe: Baseline to 24 Months/EndpointPopulation: ITT Population, LOCF (Last Observation Carried Forward)
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=186 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.
|
-20.45 Percent Change
Interval -28.68 to -12.23
|
-36.82 Percent Change
Interval -43.04 to -30.6
|
SECONDARY outcome
Timeframe: Baseline to Month 3Population: ITT Population
Outcome measures
| Measure |
Placebo
n=82 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=179 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.
|
-8.89 percent
Interval -12.25 to -5.53
|
-24.53 percent
Interval -27.05 to -22.0
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: ITT Population
Outcome measures
| Measure |
Placebo
n=81 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=178 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in BAP, Month 6, ITT Population.
|
-8.68 Percent Change
Interval -12.82 to -4.54
|
-29.78 Percent Change
Interval -32.9 to -26.66
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=175 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in BAP, Month 12, ITT Population.
|
-7.11 Percent Change
Interval -12.08 to -2.14
|
-29.51 Percent Change
Interval -33.21 to -25.81
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
Outcome measures
| Measure |
Placebo
n=72 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=163 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in BAP, Month 24, ITT Population.
|
2.95 percent
Interval -7.87 to 13.77
|
-25.20 percent
Interval -33.2 to -17.2
|
SECONDARY outcome
Timeframe: Baseline to 24 Months/EndpointPopulation: ITT Population, LOCF (Last Observation Carried Forward)
Outcome measures
| Measure |
Placebo
n=83 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=183 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.
|
1.99 Percent Change
Interval -7.6 to 11.57
|
-25.27 Percent Change
Interval -32.46 to -18.07
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
Outcome measures
| Measure |
Placebo
n=82 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=183 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Change From Baseline in Body Height, Month 12, ITT Population.
|
-0.77 millimeters
Interval -2.49 to 0.94
|
-0.92 millimeters
Interval -2.2 to 0.37
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=176 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Change From Baseline in Body Height, Month 24, ITT Population.
|
-2.66 millimeters
Interval -4.67 to -0.65
|
-3.13 millimeters
Interval -4.62 to -1.64
|
SECONDARY outcome
Timeframe: Baseline to 24 Months/EndpointPopulation: ITT Population, LOCF (Last Observation Carried Forward)
Outcome measures
| Measure |
Placebo
n=84 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=189 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.
|
-2.39 millimeters
Interval -4.34 to -0.44
|
-2.68 millimeters
Interval -4.14 to -1.22
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
responder = positive change (\>0) in lumbar spine BMD from Baseline to Month 24
Outcome measures
| Measure |
Placebo
n=78 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=172 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Percent of Responders Lumbar Spine BMD, Month 24, ITT Population
|
60.3 Percentage of Participants
|
89.5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=191 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Cumulative Incidence of Fractures, 12 Months, ITT Population
|
3.4 Fractures / 100 patients / year
|
2.7 Fractures / 100 patients / year
|
SECONDARY outcome
Timeframe: Baseline to Month 24Population: ITT Population
Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years
Outcome measures
| Measure |
Placebo
n=92 Participants
Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
|
Risedronate
n=191 Participants
35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
|
|---|---|---|
|
Cumulative Incidence of Fractures, 24 Months, ITT Population
|
7.7 Fractures / 100 patients / 2 years
|
4.9 Fractures / 100 patients / 2 years
|
Adverse Events
Placebo Year 2
Serious events: 15 serious events
Other events: 66 other events
Deaths: 0 deaths
Risedronate Year 2
Serious events: 29 serious events
Other events: 134 other events
Deaths: 0 deaths
Placebo-Risedronate Year 4
Serious events: 8 serious events
Other events: 46 other events
Deaths: 0 deaths
Risedronate Year 4
Serious events: 21 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Year 2
n=93 participants at risk
Placebo tablet once weekly Years 1 \& 2
|
Risedronate Year 2
n=191 participants at risk
Risedronate 35 mg tablet once weekly Years 1 \& 2
|
Placebo-Risedronate Year 4
n=67 participants at risk
Placebo once weekly Years 1 \& 2 followed by risedronate 35 mg once weekly Years 3 \& 4
|
Risedronate Year 4
n=151 participants at risk
Risedronate 35 mg tablet once weekly Years 1 thru 4
|
|---|---|---|---|---|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Anal Haemorrhage
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Angina Pectoris
|
1.1%
1/93 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Appendicitis
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Vascular disorders
Arteritis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Vascular disorders
Atherosclerosis Obliterans
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.0%
3/151 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar Carcinoma
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Bronchitis Acute
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Injury, poisoning and procedural complications
Burns Third Degree
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Eye disorders
Cataract
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
General disorders
Chest Pain
|
2.2%
2/93 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease Exacerbated
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.0%
2/191 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Vascular disorders
Embolism
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Gastritis Atrophic
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.0%
2/191 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Compression
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Musculoskeletal and connective tissue disorders
Localized Osteoarthritis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Myocardial Infarction
|
3.2%
3/93 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.0%
3/151 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Injury, poisoning and procedural complications
Post Laminectomy Syndrome
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.0%
2/191 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Investigations
Prostate Examination Abnormal
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Adenoma
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.2%
2/93 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Retroperitoneal Abscess
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Vascular disorders
Shock
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer, Stage Unspecified
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
General disorders
Sudden Cardiac Death
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Metabolism and nutrition disorders
Vitamin B12 Deficiency
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
Other adverse events
| Measure |
Placebo Year 2
n=93 participants at risk
Placebo tablet once weekly Years 1 \& 2
|
Risedronate Year 2
n=191 participants at risk
Risedronate 35 mg tablet once weekly Years 1 \& 2
|
Placebo-Risedronate Year 4
n=67 participants at risk
Placebo once weekly Years 1 \& 2 followed by risedronate 35 mg once weekly Years 3 \& 4
|
Risedronate Year 4
n=151 participants at risk
Risedronate 35 mg tablet once weekly Years 1 thru 4
|
|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
8/93 • Number of events 8 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
5.8%
11/191 • Number of events 13 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
4.6%
7/151 • Number of events 8 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Atrial Fibrillation
|
3.2%
3/93 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.0%
2/191 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
6.0%
4/67 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.0%
3/151 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.2%
3/93 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.1%
4/191 • Number of events 4 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.2%
2/93 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
6.8%
13/191 • Number of events 14 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
4.5%
3/67 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
6.6%
10/151 • Number of events 12 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
3.2%
3/93 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
4.7%
9/191 • Number of events 9 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
4.5%
3/67 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.3%
5/151 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
General disorders
Chest Pain
|
4.3%
4/93 • Number of events 4 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.1%
4/191 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Constipation
|
5.4%
5/93 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
8.4%
16/191 • Number of events 17 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Psychiatric disorders
Depression
|
4.3%
4/93 • Number of events 4 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.0%
2/191 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
4/93 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.6%
5/191 • Number of events 6 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Vascular disorders
Haematoma
|
3.2%
3/93 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Nervous system disorders
Headache
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
5.2%
10/191 • Number of events 10 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
6.0%
9/151 • Number of events 9 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
4.5%
3/67 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.6%
4/151 • Number of events 4 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Vascular disorders
Hypertension
|
4.3%
4/93 • Number of events 4 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.6%
5/191 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
7.3%
11/151 • Number of events 11 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Influenza
|
5.4%
5/93 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
5.8%
11/191 • Number of events 11 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.5%
1/67 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.6%
4/151 • Number of events 4 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.0%
3/151 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Cardiac disorders
Myocardial Infarction
|
3.2%
3/93 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.52%
1/191 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
5/93 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
5.8%
11/191 • Number of events 13 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
7.9%
12/151 • Number of events 15 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/93 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.1%
6/191 • Number of events 7 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.6%
5/191 • Number of events 6 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
3.2%
3/93 • Number of events 4 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
4.7%
9/191 • Number of events 9 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.3%
5/151 • Number of events 5 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Pharyngitis
|
3.2%
3/93 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.0%
2/191 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/67 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.66%
1/151 • Number of events 1 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Investigations
Prostate Examination Abnormal
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
4.5%
3/67 • Number of events 4 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.2%
3/93 • Number of events 3 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.7%
7/191 • Number of events 8 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
2.6%
4/151 • Number of events 4 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/151 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/93 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
0.00%
0/191 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
3.0%
2/67 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
1.3%
2/151 • Number of events 2 • 2 year double-blind treatment followed by 2 year open-label treatment.
Year 2, 93 placebo and 191 Risedronate patients with Most Frequent AE threshold of 3%. Year 4, 67 placebo to Risedronate patients and 151 Risedronate/Risedronate patients with Most Frequent AE threshold of 2%.
|
Additional Information
Grexan Wulff, Manager Regulatory Affairs
Warner Chilcott
Phone: 973-442-3376
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60