An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT00325468
Collaborator
(none)
200
1
75.1
Study Details
Study Description
Brief Summary
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women with Low Bone Mineral Density
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
200 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density
Actual Study Start Date
:
May 1, 2006
Actual Primary Completion Date
:
Mar 28, 2011
Actual Study Completion Date
:
Aug 2, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AMG 162 AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42 |
Drug: AMG 162
AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42
|
Outcome Measures
Primary Outcome Measures
- Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [8 years]
- Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [8 years]
- Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 [8 years]
Secondary Outcome Measures
- Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8 [8 years]
- Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8 [8 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subject must be ambulatory
-
Subject must have atteneded the 20010223 end-of-study visit and have completed all tests and procedures during the end-of-study visit
-
signed informed consent must be obtained before any study-specific procedures
Exclusion Criteria:
-
Experienced severe and/or serious adverse event which were thought to be related to denosumab administration during the 20010223 study.
-
Developed grade 3 or 4 laboratory abnormalities based on Common Terminology Criteria for Adverse Events v3.0 during the 20010223 study which did not normalized upon follow up or did not have diagnosis or treatment.
-
Newly diagnosed conditions such as hyper/hypo thyroidism, rheumatoid arthritis, other bone diseases, renal disease.
-
Using therapies while participating in the 20010223 study such as oral bisphosphonates, calcitonin, oral strontium, SERMS, systemic glucocortiocosteriods.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT00325468
Other Study ID Numbers:
- 20050233
First Posted:
May 12, 2006
Last Update Posted:
Aug 1, 2017
Last Verified:
Jul 1, 2017
Keywords provided by Amgen
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects who successfully completed the double-blind, randomized, 4-year dose-ranging parent study 20010223 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70mg QW |
|---|---|---|---|---|---|
| Arm/Group Description | In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M. | In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort. | In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate. |
| Period Title: Overall Study | |||||
| STARTED | 23 | 17 | 14 | 124 | 22 |
| COMPLETED | 12 | 12 | 10 | 90 | 14 |
| NOT COMPLETED | 11 | 5 | 4 | 34 | 8 |
Baseline Characteristics
| Arm/Group Title | Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70mg QW | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M. | In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort. | In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate. | Total of all reporting groups |
| Overall Participants | 23 | 17 | 14 | 124 | 22 | 200 |
| Age (Years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Years] |
65.8
(9.1)
|
65.8
(9.4)
|
68.0
(7.2)
|
65.8
(7.0)
|
66.6
(8.9)
|
66.1
(7.7)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
23
100%
|
17
100%
|
14
100%
|
124
100%
|
22
100%
|
200
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Number) [Number] | ||||||
| White or Caucasian |
18
78.3%
|
16
94.1%
|
12
85.7%
|
112
90.3%
|
20
90.9%
|
178
89%
|
| Black or African American |
0
0%
|
0
0%
|
1
7.1%
|
2
1.6%
|
0
0%
|
3
1.5%
|
| Hispanic or Latino |
5
21.7%
|
1
5.9%
|
1
7.1%
|
8
6.5%
|
2
9.1%
|
17
8.5%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
1
0.8%
|
0
0%
|
1
0.5%
|
| Japanese |
0
0%
|
0
0%
|
0
0%
|
1
0.8%
|
0
0%
|
1
0.5%
|
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Aborigine |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Baseline Bone Mineral Density T-score of Each Anatomic Site (T-score) [Mean (Standard Deviation) ] | ||||||
| Lumbar spine BMD T-score |
-2.36
(0.62)
|
-2.02
(1.16)
|
-1.29
(0.94)
|
-1.35
(0.87)
|
-1.64
(1.09)
|
-1.55
(0.96)
|
| Total hip BMD T-score |
-1.63
(0.75)
|
-1.39
(0.67)
|
-1.05
(0.75)
|
-1.08
(0.68)
|
-1.50
(0.81)
|
-1.21
(0.73)
|
| Distal 1/3 radius T-score |
-1.91
(1.25)
|
-1.45
(0.98)
|
-1.14
(1.29)
|
-1.23
(1.21)
|
-1.57
(0.98)
|
-1.35
(1.19)
|
Outcome Measures
| Title | Lumbar Spine Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 |
|---|---|
| Description | |
| Time Frame | 8 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with nonmissing value at parent study 20010223 baseline and Year 8 |
| Arm/Group Title | Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70mg QW |
|---|---|---|---|---|---|
| Arm/Group Description | In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M. | In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort. | In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate. |
| Measure Participants | 12 | 12 | 8 | 88 | 13 |
| Least Squares Mean (95% Confidence Interval) [percent] |
8.4
|
11.2
|
11.0
|
16.5
|
12.4
|
| Title | Bone-Specific Alkaline Phosphatase Percent Change From Parent Study 20010223 Baseline to Year 8 |
|---|---|
| Description | |
| Time Frame | 8 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with nonmissing value at parent study 20010223 baseline and Year 8 |
| Arm/Group Title | Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70mg QW |
|---|---|---|---|---|---|
| Arm/Group Description | In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M. | In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort. | In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate. |
| Measure Participants | 12 | 12 | 10 | 90 | 14 |
| Median (Inter-Quartile Range) [percent] |
-55.8
|
-44.7
|
-52.5
|
-44.4
|
-54.2
|
| Title | Total Hip Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 |
|---|---|
| Description | |
| Time Frame | 8 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with nonmissing value at parent study 20010223 baseline and Year 8 |
| Arm/Group Title | Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70mg QW |
|---|---|---|---|---|---|
| Arm/Group Description | In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M. | In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort. | In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate. |
| Measure Participants | 12 | 12 | 9 | 87 | 13 |
| Least Squares Mean (95% Confidence Interval) [percent] |
1.1
|
4.3
|
2.3
|
6.8
|
3.4
|
| Title | Distal 1/3 Radius Bone Mineral Density Percent Change From Parent Study 20010223 Baseline to Year 8 |
|---|---|
| Description | |
| Time Frame | 8 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with nonmissing value at parent study 20010223 baseline and Year 8 |
| Arm/Group Title | Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70mg QW |
|---|---|---|---|---|---|
| Arm/Group Description | In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M. | In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort. | In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate. |
| Measure Participants | 11 | 10 | 9 | 87 | 13 |
| Least Squares Mean (95% Confidence Interval) [percent] |
-5.2
|
1.4
|
0.6
|
1.3
|
-2.2
|
| Title | Serum C-Telopeptide Percent Change From Parent Study 20010223 Baseline to Year 8 |
|---|---|
| Description | |
| Time Frame | 8 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects with nonmissing value at parent study 20010223 baseline and Year 8 |
| Arm/Group Title | Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70mg QW |
|---|---|---|---|---|---|
| Arm/Group Description | In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M. | In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort. | In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate. |
| Measure Participants | 12 | 13 | 10 | 89 | 13 |
| Median (Inter-Quartile Range) [percent] |
-66.4
|
-72.0
|
-48.0
|
-64.6
|
-49.8
|
Adverse Events
| Time Frame | 48 months (i.e., 4 years during the 20050233 extension study) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. | |||||||||||
| Arm/Group Title | Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70 mg QW | All Participants | ||||||
| Arm/Group Description | In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M. | In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study. | In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort. | ||||||||
All Cause Mortality |
||||||||||||
| Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70 mg QW | All Participants | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70 mg QW | All Participants | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/23 (13%) | 3/17 (17.6%) | 5/14 (35.7%) | 31/124 (25%) | 3/22 (13.6%) | 45/200 (22.5%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Hypochromic anaemia | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Cardiac disorders | ||||||||||||
| Angina unstable | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Atrial fibrillation | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Atrial flutter | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Cardiac arrest | 1/23 (4.3%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Cardiac failure | 1/23 (4.3%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Cardiac failure congestive | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Coronary artery disease | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Coronary artery stenosis | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Mitral valve incompetence | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Abdominal hernia | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Colonic stenosis | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Hiatus hernia | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 1/22 (4.5%) | 1/200 (0.5%) | ||||||
| Pancreatitis | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Rectal haemorrhage | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| General disorders | ||||||||||||
| Chest discomfort | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Chest pain | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Death | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Non-cardiac chest pain | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 3/124 (2.4%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Performance status decreased | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Pyrexia | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Cholecystitis acute | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Cholelithiasis | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Immune system disorders | ||||||||||||
| Seasonal allergy | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Infections and infestations | ||||||||||||
| Diverticulitis | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 1/22 (4.5%) | 1/200 (0.5%) | ||||||
| Endocarditis | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Pneumonia | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Respiratory tract infection | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 1/22 (4.5%) | 1/200 (0.5%) | ||||||
| Respiratory tract infection viral | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 1/22 (4.5%) | 1/200 (0.5%) | ||||||
| Staphylococcal bacteraemia | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Fibula fracture | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Traumatic brain injury | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Investigations | ||||||||||||
| Weight decreased | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Dehydration | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Diabetic ketoacidosis | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 1/22 (4.5%) | 1/200 (0.5%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Back pain | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Osteoarthritis | 0/23 (0%) | 1/17 (5.9%) | 3/14 (21.4%) | 0/124 (0%) | 0/22 (0%) | 4/200 (2%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Benign gastrointestinal neoplasm | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Bone neoplasm malignant | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Breast cancer | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Breast cancer in situ | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Colon cancer metastatic | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Endometrial cancer stage I | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Hepatic neoplasm malignant | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Lung neoplasm | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Lung neoplasm malignant | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 2/124 (1.6%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Non-Hodgkin's lymphoma stage III | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Non-small cell lung cancer stage IIIB | 1/23 (4.3%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Ovarian cancer metastatic | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Pancreatic carcinoma | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Nervous system disorders | ||||||||||||
| Cerebrovascular accident | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Coma | 1/23 (4.3%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Syncope | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Psychiatric disorders | ||||||||||||
| Suicidal ideation | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Urinary incontinence | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| Cystocele | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Rectocele | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Uterovaginal prolapse | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Asthma | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 1/22 (4.5%) | 1/200 (0.5%) | ||||||
| Chronic obstructive pulmonary disease | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Dyspnoea | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 2/124 (1.6%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Pneumonia aspiration | 1/23 (4.3%) | 0/17 (0%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Pulmonary embolism | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 2/124 (1.6%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Respiratory distress | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Vascular disorders | ||||||||||||
| Arterial thrombosis limb | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Haematoma | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| Placebo | Denosumab 210 mg Q6M | Denosumab 30 mg Q3M | Denosumab Continuous Treatment | Alendronate 70 mg QW | All Participants | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/23 (78.3%) | 15/17 (88.2%) | 13/14 (92.9%) | 106/124 (85.5%) | 19/22 (86.4%) | 171/200 (85.5%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 3/124 (2.4%) | 0/22 (0%) | 4/200 (2%) | ||||||
| Cardiac disorders | ||||||||||||
| Atrial flutter | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Bundle branch block right | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Cardiac failure congestive | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Myocardial infarction | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Palpitations | 1/23 (4.3%) | 1/17 (5.9%) | 0/14 (0%) | 2/124 (1.6%) | 1/22 (4.5%) | 5/200 (2.5%) | ||||||
| Ear and labyrinth disorders | ||||||||||||
| Ear congestion | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Hearing impaired | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Vertigo | 2/23 (8.7%) | 0/17 (0%) | 0/14 (0%) | 5/124 (4%) | 0/22 (0%) | 7/200 (3.5%) | ||||||
| Endocrine disorders | ||||||||||||
| Hypothyroidism | 1/23 (4.3%) | 2/17 (11.8%) | 0/14 (0%) | 2/124 (1.6%) | 1/22 (4.5%) | 6/200 (3%) | ||||||
| Eye disorders | ||||||||||||
| Angle closure glaucoma | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Blepharospasm | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Cataract | 3/23 (13%) | 1/17 (5.9%) | 2/14 (14.3%) | 13/124 (10.5%) | 3/22 (13.6%) | 22/200 (11%) | ||||||
| Diplopia | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Dry eye | 1/23 (4.3%) | 1/17 (5.9%) | 2/14 (14.3%) | 1/124 (0.8%) | 1/22 (4.5%) | 6/200 (3%) | ||||||
| Eye pain | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Eye swelling | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Glaucoma | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 1/22 (4.5%) | 3/200 (1.5%) | ||||||
| Scleral haemorrhage | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Visual acuity reduced | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Abdominal discomfort | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Colonic polyp | 0/23 (0%) | 0/17 (0%) | 0/14 (0%) | 4/124 (3.2%) | 2/22 (9.1%) | 6/200 (3%) | ||||||
| Constipation | 1/23 (4.3%) | 2/17 (11.8%) | 0/14 (0%) | 4/124 (3.2%) | 1/22 (4.5%) | 8/200 (4%) | ||||||
| Diarrhoea | 1/23 (4.3%) | 2/17 (11.8%) | 0/14 (0%) | 3/124 (2.4%) | 3/22 (13.6%) | 9/200 (4.5%) | ||||||
| Dyspepsia | 1/23 (4.3%) | 2/17 (11.8%) | 0/14 (0%) | 3/124 (2.4%) | 1/22 (4.5%) | 7/200 (3.5%) | ||||||
| Flatulence | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Gastrooesophageal reflux disease | 1/23 (4.3%) | 0/17 (0%) | 2/14 (14.3%) | 6/124 (4.8%) | 2/22 (9.1%) | 11/200 (5.5%) | ||||||
| Haemorrhoids | 0/23 (0%) | 1/17 (5.9%) | 2/14 (14.3%) | 1/124 (0.8%) | 1/22 (4.5%) | 5/200 (2.5%) | ||||||
| Hiatus hernia | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Intestinal haemorrhage | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Nausea | 1/23 (4.3%) | 1/17 (5.9%) | 2/14 (14.3%) | 6/124 (4.8%) | 1/22 (4.5%) | 11/200 (5.5%) | ||||||
| Odynophagia | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Oesophagitis | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Oral disorder | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Rectal polyp | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Vomiting | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| General disorders | ||||||||||||
| Fatigue | 0/23 (0%) | 0/17 (0%) | 2/14 (14.3%) | 7/124 (5.6%) | 2/22 (9.1%) | 11/200 (5.5%) | ||||||
| Malaise | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Medical device complication | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Non-cardiac chest pain | 0/23 (0%) | 0/17 (0%) | 2/14 (14.3%) | 2/124 (1.6%) | 1/22 (4.5%) | 5/200 (2.5%) | ||||||
| Oedema peripheral | 1/23 (4.3%) | 0/17 (0%) | 1/14 (7.1%) | 7/124 (5.6%) | 0/22 (0%) | 9/200 (4.5%) | ||||||
| Pyrexia | 1/23 (4.3%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Cholelithiasis | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 1/22 (4.5%) | 3/200 (1.5%) | ||||||
| Infections and infestations | ||||||||||||
| Bronchitis | 2/23 (8.7%) | 4/17 (23.5%) | 3/14 (21.4%) | 7/124 (5.6%) | 1/22 (4.5%) | 17/200 (8.5%) | ||||||
| Fungal oesophagitis | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Gastroenteritis viral | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 1/22 (4.5%) | 3/200 (1.5%) | ||||||
| Herpes zoster | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 3/124 (2.4%) | 1/22 (4.5%) | 5/200 (2.5%) | ||||||
| Influenza | 1/23 (4.3%) | 0/17 (0%) | 1/14 (7.1%) | 5/124 (4%) | 3/22 (13.6%) | 10/200 (5%) | ||||||
| Localised infection | 0/23 (0%) | 1/17 (5.9%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Nasopharyngitis | 2/23 (8.7%) | 1/17 (5.9%) | 0/14 (0%) | 10/124 (8.1%) | 2/22 (9.1%) | 15/200 (7.5%) | ||||||
| Oral candidiasis | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Otitis externa | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Sinusitis | 2/23 (8.7%) | 1/17 (5.9%) | 1/14 (7.1%) | 18/124 (14.5%) | 1/22 (4.5%) | 23/200 (11.5%) | ||||||
| Skin bacterial infection | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Skin infection | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Staphylococcal infection | 1/23 (4.3%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Upper respiratory tract infection | 9/23 (39.1%) | 7/17 (41.2%) | 2/14 (14.3%) | 24/124 (19.4%) | 3/22 (13.6%) | 45/200 (22.5%) | ||||||
| Urinary tract infection | 1/23 (4.3%) | 1/17 (5.9%) | 1/14 (7.1%) | 15/124 (12.1%) | 2/22 (9.1%) | 20/200 (10%) | ||||||
| Viral infection | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 1/22 (4.5%) | 2/200 (1%) | ||||||
| Viral upper respiratory tract infection | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Vulvovaginal mycotic infection | 1/23 (4.3%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Contusion | 1/23 (4.3%) | 0/17 (0%) | 2/14 (14.3%) | 8/124 (6.5%) | 0/22 (0%) | 11/200 (5.5%) | ||||||
| Epicondylitis | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Excoriation | 3/23 (13%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 4/200 (2%) | ||||||
| Facial bones fracture | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Fall | 2/23 (8.7%) | 1/17 (5.9%) | 1/14 (7.1%) | 9/124 (7.3%) | 0/22 (0%) | 13/200 (6.5%) | ||||||
| Fibula fracture | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Gastrointestinal injury | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Head injury | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Humerus fracture | 1/23 (4.3%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Joint injury | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Laceration | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 3/124 (2.4%) | 0/22 (0%) | 4/200 (2%) | ||||||
| Ligament rupture | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Meniscus lesion | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Post procedural complication | 1/23 (4.3%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Procedural hypotension | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 1/22 (4.5%) | 2/200 (1%) | ||||||
| Procedural pain | 2/23 (8.7%) | 0/17 (0%) | 3/14 (21.4%) | 7/124 (5.6%) | 3/22 (13.6%) | 15/200 (7.5%) | ||||||
| Rib fracture | 1/23 (4.3%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Thoracic vertebral fracture | 0/23 (0%) | 1/17 (5.9%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Tibia fracture | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Tooth fracture | 1/23 (4.3%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Investigations | ||||||||||||
| Alanine aminotransferase increased | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Aspartate aminotransferase increased | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Blood cholesterol increased | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Chest X-ray abnormal | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 1/22 (4.5%) | 2/200 (1%) | ||||||
| Weight decreased | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Dyslipidaemia | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Hypercholesterolaemia | 0/23 (0%) | 2/17 (11.8%) | 0/14 (0%) | 3/124 (2.4%) | 2/22 (9.1%) | 7/200 (3.5%) | ||||||
| Hyperlipidaemia | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 4/23 (17.4%) | 4/17 (23.5%) | 4/14 (28.6%) | 20/124 (16.1%) | 5/22 (22.7%) | 37/200 (18.5%) | ||||||
| Arthritis | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Back pain | 3/23 (13%) | 4/17 (23.5%) | 1/14 (7.1%) | 14/124 (11.3%) | 3/22 (13.6%) | 25/200 (12.5%) | ||||||
| Bursitis | 2/23 (8.7%) | 0/17 (0%) | 0/14 (0%) | 6/124 (4.8%) | 0/22 (0%) | 8/200 (4%) | ||||||
| Intervertebral disc degeneration | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Joint swelling | 1/23 (4.3%) | 0/17 (0%) | 1/14 (7.1%) | 3/124 (2.4%) | 0/22 (0%) | 5/200 (2.5%) | ||||||
| Kyphosis | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Lumbar spinal stenosis | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Muscle spasms | 4/23 (17.4%) | 0/17 (0%) | 1/14 (7.1%) | 7/124 (5.6%) | 1/22 (4.5%) | 13/200 (6.5%) | ||||||
| Musculoskeletal pain | 4/23 (17.4%) | 0/17 (0%) | 1/14 (7.1%) | 9/124 (7.3%) | 0/22 (0%) | 14/200 (7%) | ||||||
| Myalgia | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 4/124 (3.2%) | 0/22 (0%) | 5/200 (2.5%) | ||||||
| Neck pain | 2/23 (8.7%) | 0/17 (0%) | 0/14 (0%) | 2/124 (1.6%) | 2/22 (9.1%) | 6/200 (3%) | ||||||
| Osteoarthritis | 0/23 (0%) | 1/17 (5.9%) | 2/14 (14.3%) | 5/124 (4%) | 1/22 (4.5%) | 9/200 (4.5%) | ||||||
| Pain in extremity | 2/23 (8.7%) | 4/17 (23.5%) | 0/14 (0%) | 14/124 (11.3%) | 3/22 (13.6%) | 23/200 (11.5%) | ||||||
| Plantar fasciitis | 1/23 (4.3%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Spinal column stenosis | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Trendelenburg's symptom | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Basal cell carcinoma | 2/23 (8.7%) | 1/17 (5.9%) | 0/14 (0%) | 8/124 (6.5%) | 0/22 (0%) | 11/200 (5.5%) | ||||||
| Ovarian germ cell teratoma benign | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Uterine leiomyoma | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Nervous system disorders | ||||||||||||
| Balance disorder | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Carpal tunnel syndrome | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Cerebrovascular accident | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Cognitive disorder | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Dizziness | 1/23 (4.3%) | 1/17 (5.9%) | 0/14 (0%) | 6/124 (4.8%) | 0/22 (0%) | 8/200 (4%) | ||||||
| Headache | 1/23 (4.3%) | 0/17 (0%) | 0/14 (0%) | 8/124 (6.5%) | 1/22 (4.5%) | 10/200 (5%) | ||||||
| Memory impairment | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Migraine | 2/23 (8.7%) | 0/17 (0%) | 0/14 (0%) | 3/124 (2.4%) | 0/22 (0%) | 5/200 (2.5%) | ||||||
| Neuralgia | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Paraesthesia | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Sciatica | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 4/124 (3.2%) | 1/22 (4.5%) | 6/200 (3%) | ||||||
| Syncope | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 3/124 (2.4%) | 0/22 (0%) | 4/200 (2%) | ||||||
| Psychiatric disorders | ||||||||||||
| Depression | 3/23 (13%) | 3/17 (17.6%) | 0/14 (0%) | 6/124 (4.8%) | 2/22 (9.1%) | 14/200 (7%) | ||||||
| Insomnia | 0/23 (0%) | 1/17 (5.9%) | 1/14 (7.1%) | 12/124 (9.7%) | 0/22 (0%) | 14/200 (7%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Haematuria | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 1/22 (4.5%) | 2/200 (1%) | ||||||
| Renal failure | 1/23 (4.3%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Urinary incontinence | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| Ovarian cyst | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 2/23 (8.7%) | 1/17 (5.9%) | 1/14 (7.1%) | 3/124 (2.4%) | 1/22 (4.5%) | 8/200 (4%) | ||||||
| Dyspnoea | 0/23 (0%) | 1/17 (5.9%) | 1/14 (7.1%) | 2/124 (1.6%) | 0/22 (0%) | 4/200 (2%) | ||||||
| Dyspnoea exertional | 1/23 (4.3%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Nasal congestion | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Nasal dryness | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Oropharyngeal pain | 0/23 (0%) | 1/17 (5.9%) | 0/14 (0%) | 4/124 (3.2%) | 1/22 (4.5%) | 6/200 (3%) | ||||||
| Pneumothorax | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Rales | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Respiratory failure | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Respiratory tract congestion | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Actinic keratosis | 2/23 (8.7%) | 0/17 (0%) | 0/14 (0%) | 1/124 (0.8%) | 1/22 (4.5%) | 4/200 (2%) | ||||||
| Alopecia | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Alopecia areata | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Dry skin | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 1/124 (0.8%) | 0/22 (0%) | 2/200 (1%) | ||||||
| Pruritus generalised | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Psoriasis | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 2/124 (1.6%) | 0/22 (0%) | 3/200 (1.5%) | ||||||
| Rash | 2/23 (8.7%) | 2/17 (11.8%) | 0/14 (0%) | 2/124 (1.6%) | 0/22 (0%) | 6/200 (3%) | ||||||
| Skin lesion | 2/23 (8.7%) | 1/17 (5.9%) | 0/14 (0%) | 1/124 (0.8%) | 1/22 (4.5%) | 5/200 (2.5%) | ||||||
| Swelling face | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
| Vascular disorders | ||||||||||||
| Hypertension | 2/23 (8.7%) | 3/17 (17.6%) | 4/14 (28.6%) | 13/124 (10.5%) | 3/22 (13.6%) | 25/200 (12.5%) | ||||||
| Peripheral coldness | 0/23 (0%) | 0/17 (0%) | 1/14 (7.1%) | 0/124 (0%) | 0/22 (0%) | 1/200 (0.5%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Amgen Inc. |
| Phone | 866-572-6436 |
Responsible Party:
Amgen
ClinicalTrials.gov Identifier:
NCT00325468
Other Study ID Numbers:
- 20050233
First Posted:
May 12, 2006
Last Update Posted:
Aug 1, 2017
Last Verified:
Jul 1, 2017