Trial Outcomes & Findings for Efficacy and Safety of Denosumab Compared With Risedronate in Individuals Taking Glucocorticoids (NCT NCT01575873)
NCT ID: NCT01575873
Last Updated: 2018-07-27
Results Overview
Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
795 participants
Primary outcome timeframe
Baseline and month 12
Results posted on
2018-07-27
Participant Flow
Participants were enrolled at 79 centers in Europe, North America, Latin America, and Korea from 28 March 2012 to 30 June 2015. Participants who had been taking glucocorticoids for at least 3 months were classed as glucocorticoid continuing; those who were taking glucocorticoids for less than 3 months were classed as glucocorticoid initiating.
Eligible patients were randomly assigned in a 1:1 ratio to receive 60 mg denosumab every 6 months or 5 mg oral risedronate daily for 24 months within each subpopulation. Randomization was stratified by sex within each subpopulation.
Participant milestones
| Measure |
Risedronate: Glucocorticoid-initiating
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-initiating
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
Risedronate: Glucocorticoid-continuing
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-continuing
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
145
|
145
|
252
|
253
|
|
Overall Study
Received Study Drug
|
140
|
142
|
246
|
251
|
|
Overall Study
COMPLETED
|
117
|
109
|
178
|
186
|
|
Overall Study
NOT COMPLETED
|
28
|
36
|
74
|
67
|
Reasons for withdrawal
| Measure |
Risedronate: Glucocorticoid-initiating
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-initiating
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
Risedronate: Glucocorticoid-continuing
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-continuing
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
15
|
20
|
34
|
34
|
|
Overall Study
Adverse Event
|
7
|
7
|
9
|
12
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
13
|
5
|
|
Overall Study
Death
|
3
|
2
|
8
|
9
|
|
Overall Study
Noncompliance
|
1
|
2
|
4
|
3
|
|
Overall Study
Administrative decision
|
1
|
1
|
1
|
0
|
|
Overall Study
Protocol deviation
|
0
|
1
|
0
|
1
|
|
Overall Study
Requirement for Alternative Therapy
|
0
|
0
|
1
|
1
|
|
Overall Study
Other
|
0
|
0
|
4
|
2
|
Baseline Characteristics
Females only
Baseline characteristics by cohort
| Measure |
Risedronate: Glucocorticoid-initiating
n=145 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-initiating
n=145 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
Risedronate: Glucocorticoid-continuing
n=252 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-continuing
n=253 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
Total
n=795 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 10.0 • n=145 Participants
|
67.5 years
STANDARD_DEVIATION 10.1 • n=145 Participants
|
61.3 years
STANDARD_DEVIATION 11.1 • n=252 Participants
|
61.5 years
STANDARD_DEVIATION 11.6 • n=253 Participants
|
63.1 years
STANDARD_DEVIATION 11.1 • n=795 Participants
|
|
Age, Customized
< 50 years
|
5 Participants
n=145 Participants
|
2 Participants
n=145 Participants
|
26 Participants
n=252 Participants
|
33 Participants
n=253 Participants
|
66 Participants
n=795 Participants
|
|
Age, Customized
50 - 64 years
|
75 Participants
n=145 Participants
|
55 Participants
n=145 Participants
|
130 Participants
n=252 Participants
|
114 Participants
n=253 Participants
|
374 Participants
n=795 Participants
|
|
Age, Customized
65 - 74 years
|
38 Participants
n=145 Participants
|
50 Participants
n=145 Participants
|
62 Participants
n=252 Participants
|
73 Participants
n=253 Participants
|
223 Participants
n=795 Participants
|
|
Age, Customized
≥ 75 years
|
27 Participants
n=145 Participants
|
38 Participants
n=145 Participants
|
34 Participants
n=252 Participants
|
33 Participants
n=253 Participants
|
132 Participants
n=795 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=145 Participants
|
93 Participants
n=145 Participants
|
185 Participants
n=252 Participants
|
185 Participants
n=253 Participants
|
556 Participants
n=795 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=145 Participants
|
52 Participants
n=145 Participants
|
67 Participants
n=252 Participants
|
68 Participants
n=253 Participants
|
239 Participants
n=795 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=145 Participants
|
20 Participants
n=145 Participants
|
54 Participants
n=252 Participants
|
43 Participants
n=253 Participants
|
135 Participants
n=795 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=145 Participants
|
125 Participants
n=145 Participants
|
198 Participants
n=252 Participants
|
210 Participants
n=253 Participants
|
660 Participants
n=795 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=145 Participants
|
0 Participants
n=145 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=253 Participants
|
0 Participants
n=795 Participants
|
|
Race/Ethnicity, Customized
White
|
123 Participants
n=145 Participants
|
122 Participants
n=145 Participants
|
223 Participants
n=252 Participants
|
230 Participants
n=253 Participants
|
698 Participants
n=795 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=145 Participants
|
12 Participants
n=145 Participants
|
11 Participants
n=252 Participants
|
13 Participants
n=253 Participants
|
47 Participants
n=795 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=145 Participants
|
9 Participants
n=145 Participants
|
12 Participants
n=252 Participants
|
6 Participants
n=253 Participants
|
36 Participants
n=795 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=145 Participants
|
2 Participants
n=145 Participants
|
4 Participants
n=252 Participants
|
4 Participants
n=253 Participants
|
12 Participants
n=795 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=145 Participants
|
0 Participants
n=145 Participants
|
1 Participants
n=252 Participants
|
0 Participants
n=253 Participants
|
1 Participants
n=795 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=145 Participants
|
0 Participants
n=145 Participants
|
1 Participants
n=252 Participants
|
0 Participants
n=253 Participants
|
1 Participants
n=795 Participants
|
|
Menopausal Status
Premenopause
|
7 Participants
n=93 Participants • Females only
|
10 Participants
n=93 Participants • Females only
|
25 Participants
n=185 Participants • Females only
|
24 Participants
n=185 Participants • Females only
|
66 Participants
n=556 Participants • Females only
|
|
Menopausal Status
Postmenopause
|
83 Participants
n=93 Participants • Females only
|
82 Participants
n=93 Participants • Females only
|
157 Participants
n=185 Participants • Females only
|
159 Participants
n=185 Participants • Females only
|
481 Participants
n=556 Participants • Females only
|
|
Menopausal Status
Unknown
|
3 Participants
n=93 Participants • Females only
|
1 Participants
n=93 Participants • Females only
|
3 Participants
n=185 Participants • Females only
|
2 Participants
n=185 Participants • Females only
|
9 Participants
n=556 Participants • Females only
|
|
Lumbar Spine Bone Mineral Density (BMD) T-score
Glucocorticoid-initiating Subpopulation
|
-1.06 T-score
STANDARD_DEVIATION 1.57 • n=143 Participants • Participants with observed values
|
-0.92 T-score
STANDARD_DEVIATION 1.86 • n=144 Participants • Participants with observed values
|
—
|
—
|
-0.99 T-score
STANDARD_DEVIATION 1.72 • n=287 Participants • Participants with observed values
|
|
Lumbar Spine Bone Mineral Density (BMD) T-score
Glucocorticoid-continuing Subpopulation
|
—
|
—
|
-1.96 T-score
STANDARD_DEVIATION 1.38 • n=252 Participants • Participants with observed values
|
-1.92 T-score
STANDARD_DEVIATION 1.38 • n=249 Participants • Participants with observed values
|
-1.94 T-score
STANDARD_DEVIATION 1.38 • n=501 Participants • Participants with observed values
|
|
Total Hip BMD T-score
Glucocorticoid-initiating Subpopulation
|
-0.98 T-score
STANDARD_DEVIATION 1.07 • n=142 Participants • participants with observed vaues
|
-1.14 T-score
STANDARD_DEVIATION 1.00 • n=142 Participants • participants with observed vaues
|
—
|
—
|
-1.06 T-score
STANDARD_DEVIATION 1.04 • n=284 Participants • participants with observed vaues
|
|
Total Hip BMD T-score
Glucocorticoid-continuing Subpopulation
|
—
|
—
|
-1.56 T-score
STANDARD_DEVIATION 0.96 • n=250 Participants • participants with observed vaues
|
-1.66 T-score
STANDARD_DEVIATION 0.96 • n=249 Participants • participants with observed vaues
|
-1.61 T-score
STANDARD_DEVIATION 0.96 • n=499 Participants • participants with observed vaues
|
PRIMARY outcome
Timeframe: Baseline and month 12Population: Randomized participants with a baseline and month 12 measurement for the lumbar spine BMD.
Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Risedronate: Glucocorticoid-initiating
n=126 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-initiating
n=119 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
Risedronate: Glucocorticoid-continuing
n=211 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-continuing
n=209 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Non-inferiority Analysis)
|
0.8 percent change
Interval 0.2 to 1.5
|
3.8 percent change
Interval 3.1 to 4.5
|
2.3 percent change
Interval 1.7 to 2.9
|
4.4 percent change
Interval 3.8 to 5.0
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: Randomized participants with a baseline and month 12 measurement for the lumbar spine BMD.
Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Risedronate: Glucocorticoid-initiating
n=126 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-initiating
n=119 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
Risedronate: Glucocorticoid-continuing
n=211 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-continuing
n=209 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12 (Superiority Analysis)
|
0.8 percent change
Interval 0.2 to 1.5
|
3.8 percent change
Interval 3.1 to 4.5
|
2.3 percent change
Interval 1.7 to 2.9
|
4.4 percent change
Interval 3.8 to 5.0
|
SECONDARY outcome
Timeframe: Baseline and month 12Population: Randomized participants with a baseline and month 12 measurement for the total hip BMD.
Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Risedronate: Glucocorticoid-initiating
n=128 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-initiating
n=119 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
Risedronate: Glucocorticoid-continuing
n=215 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-continuing
n=217 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12
|
0.2 percent change
Interval -0.2 to 0.7
|
1.7 percent change
Interval 1.2 to 2.2
|
0.6 percent change
Interval 0.2 to 1.0
|
2.1 percent change
Interval 1.7 to 2.5
|
SECONDARY outcome
Timeframe: Baseline and month 24Population: Randomized participants with a baseline and month 24 measurement for the lumbar spine BMD.
Bone mineral density at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Risedronate: Glucocorticoid-initiating
n=113 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-initiating
n=107 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
Risedronate: Glucocorticoid-continuing
n=174 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-continuing
n=183 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 24
|
1.7 percent change
Interval 0.8 to 2.7
|
6.2 percent change
Interval 5.3 to 7.2
|
3.2 percent change
Interval 2.3 to 4.1
|
6.4 percent change
Interval 5.5 to 7.2
|
SECONDARY outcome
Timeframe: Baseline and month 24Population: Randomized participants with a baseline and month 24 measurement for the total hip BMD.
Bone mineral density at the total hip was measured by dual-energy x-ray absorptiometry (DXA).
Outcome measures
| Measure |
Risedronate: Glucocorticoid-initiating
n=111 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-initiating
n=104 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
Risedronate: Glucocorticoid-continuing
n=176 Participants
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab: Glucocorticoid-continuing
n=181 Participants
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Total Hip Bone Mineral Density at Month 24
|
-0.0 percent change
Interval -0.6 to 0.6
|
3.1 percent change
Interval 2.4 to 3.7
|
0.5 percent change
Interval -0.1 to 1.0
|
2.9 percent change
Interval 2.4 to 3.5
|
Adverse Events
Risedronate
Serious events: 98 serious events
Other events: 76 other events
Deaths: 9 deaths
Denosumab
Serious events: 92 serious events
Other events: 77 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Risedronate
n=385 participants at risk
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab
n=394 participants at risk
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.76%
3/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood pressure increased
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
White blood cell count increased
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Periarthritis calcarea
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.78%
3/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Exposed bone in jaw
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Mixed connective tissue disease
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
5/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ataxia
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.76%
3/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hemiparesis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hydrocephalus
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Multiple sclerosis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paresis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Presyncope
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Sciatica
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Seizure
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.76%
3/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Behaviour disorder due to a general medical condition
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Confusional state
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Delirium
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Lupus nephritis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Cervix haematoma uterine
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Cystocele
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.78%
3/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
5/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cataract operation
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Colectomy
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Ileostomy
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Lung neoplasm surgery
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Sigmoidectomy
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Spinal decompression
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic stenosis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haemodynamic instability
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombosis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vasculitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Helicobacter gastritis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.76%
3/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Mitral valve disease
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Congenital megaureter
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Glaucoma
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dysphagia
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastritis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Subileus
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Death
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Eosinophilic granulomatosis with polyangiitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Food allergy
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abdominal abscess
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess limb
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Anal abscess
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Haemorrhagic fever
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium colitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Erysipelas
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lymphangitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Necrotising fasciitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Peritonitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Peritonsillar abscess
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
2.1%
8/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
7/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis acute
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
0.52%
2/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Serratia infection
|
0.00%
0/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.25%
1/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
0.26%
1/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Risedronate
n=385 participants at risk
Participants received 5 mg risedronate orally once a day for 24 months and placebo to densumab by subcutaneous injection on day 1 and at months 6, 12, and 18.
|
Denosumab
n=394 participants at risk
Participants received 60 mg denosumab by subcutaneous injection on day 1 and at months 6, 12, and 18. Participants also received placebo to risedronate orally once a day for 24 months.
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.9%
19/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
20/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
33/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.8%
23/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.5%
21/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.1%
24/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
3.9%
15/385 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
21/394 • 24 months.
One participant was randomized to risedronate but received denosumab in error; this participant was included in the denosumab group for safety analyses. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER