Trial Outcomes & Findings for Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance - (NCT NCT02106455)
NCT ID: NCT02106455
Last Updated: 2019-06-03
Results Overview
Adverse drug reaction refers to adverse events related to administered drug.
COMPLETED
315 participants
Up to 48 weeks
2019-06-03
Participant Flow
Participants took part in the study at 92 investigative sites in Japan, from 01 August 2008 to 24 October 2017.
Participants with a historical diagnosis of osseous Paget's disease were enrolled. Participants received interventions as part of routine medical care.
Participant milestones
| Measure |
Sodium Risedronate 17.5 mg
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Overall Study
STARTED
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315
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Overall Study
COMPLETED
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307
|
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Overall Study
NOT COMPLETED
|
8
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Reasons for withdrawal
| Measure |
Sodium Risedronate 17.5 mg
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Overall Study
Case Report Form Uncollected
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6
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Overall Study
Protocol Deviation
|
2
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Baseline Characteristics
The number analyzed is the number of participants with data available for analysis.
Baseline characteristics by cohort
| Measure |
Sodium Risedronate 17.5 mg
n=307 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Age, Continuous
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63.2 Years
STANDARD_DEVIATION 12.2 • n=304 Participants • The number analyzed is the number of participants with data available for analysis.
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Sex: Female, Male
Female
|
134 Participants
n=307 Participants
|
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Sex: Female, Male
Male
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173 Participants
n=307 Participants
|
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Region of Enrollment
Japan
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307 Participants
n=307 Participants
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Pregnancy Status (not pregnant)
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134 Participants
n=134 Participants • This baseline characteristic was analyzed only in female participants.
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Height
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159.49 Centimeters (cm)
STANDARD_DEVIATION 9.78 • n=167 Participants • The number analyzed is the number of participants with data available for analysis.
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Weight
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59.74 Kilograms (kg)
STANDARD_DEVIATION 12.04 • n=170 Participants • The number analyzed is the number of participants with data available for analysis.
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Classification by Treatment History
Initial Treatment
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184 Participants
n=307 Participants
|
|
Classification by Treatment History
Repetitive Treatment
|
123 Participants
n=307 Participants
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Treatment Duration
≤ 56 Days
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145 Participants
n=307 Participants
|
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Treatment Duration
≥ 57 Days
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159 Participants
n=307 Participants
|
|
Treatment Duration
Unknown
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3 Participants
n=307 Participants
|
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Healthcare Category
Outpatient
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288 Participants
n=307 Participants
|
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Healthcare Category
Outpatient and Inpatient
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19 Participants
n=307 Participants
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Detailed Diagnosis of Osseous Paget's Disease
Monostotic Osseous Paget's Disease
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125 Participants
n=307 Participants
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Detailed Diagnosis of Osseous Paget's Disease
Polyostotic Osseous Paget's Disease
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176 Participants
n=307 Participants
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Detailed Diagnosis of Osseous Paget's Disease
Undifferentiated/Unknown
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6 Participants
n=307 Participants
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Duration of Diagnosis of Osseous Paget's Disease
< 1 Year
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106 Participants
n=307 Participants
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Duration of Diagnosis of Osseous Paget's Disease
1 to < 5 Years
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60 Participants
n=307 Participants
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Duration of Diagnosis of Osseous Paget's Disease
≥ 5 Years
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71 Participants
n=307 Participants
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Duration of Diagnosis of Osseous Paget's Disease
Unknown (Not Reported)
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70 Participants
n=307 Participants
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Medical Complications
Had No Presence of Medical Complications
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105 Participants
n=307 Participants
|
|
Medical Complications
Had Presence of Medical Complications
|
202 Participants
n=307 Participants
|
|
Medical History
Had No Medical History
|
156 Participants
n=307 Participants
|
|
Medical History
Had Medical History
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150 Participants
n=307 Participants
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|
Medical History
Unknown
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1 Participants
n=307 Participants
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Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
290 Participants
n=307 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
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9 Participants
n=307 Participants
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Predisposition to Hypersensitivity
Unknown
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8 Participants
n=307 Participants
|
|
Family History of Osseous Paget's Disease
Had No Family History
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231 Participants
n=307 Participants
|
|
Family History of Osseous Paget's Disease
Had Family History
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7 Participants
n=307 Participants
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|
Family History of Osseous Paget's Disease
Unknown
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69 Participants
n=307 Participants
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Experience of Fracture at Disease Site
Had No Experiences
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274 Participants
n=307 Participants
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Experience of Fracture at Disease Site
Had Experience
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33 Participants
n=307 Participants
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Past Drug Therapy for Osseous Paget's Disease
Had No Therapies
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92 Participants
n=307 Participants
|
|
Past Drug Therapy for Osseous Paget's Disease
Had Therapy
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209 Participants
n=307 Participants
|
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Past Drug Therapy for Osseous Paget's Disease
Unknown
|
6 Participants
n=307 Participants
|
|
Concurrent Medication
Had No Concurrent Medication
|
134 Participants
n=307 Participants
|
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Concurrent Medication
Had Concurrent Medication
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173 Participants
n=307 Participants
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PRIMARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Adverse drug reaction refers to adverse events related to administered drug.
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=307 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Percentage of Participants Who Had One or More Adverse Drug Reactions
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14.98 Percentage of Participants
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SECONDARY outcome
Timeframe: Baseline and final assessment point (Up to 48 weeks)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported.
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=251 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
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-72.47 Percentage of change
Standard Deviation 125.78
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SECONDARY outcome
Timeframe: Baseline and final assessment point (Up to 48 weeks)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported.
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=251 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
|
-31.71 Percentage of change
Standard Deviation 30.47
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SECONDARY outcome
Timeframe: Baseline and final assessment point (Up to 48 weeks)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Investigators marked severity of pain with a 4-point scale ranging from "None" to "Very Severe" (None, Mild, Severe, Very Severe) at baseline and the final assessment point. This scale was specified on the protocol of this observational study. The reported data were number of participants stratified by comparison of pain severity between baseline and final assessment point described as "None (at baseline) to Severe (at final assessment point)".
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=258 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
None to None
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138 Participants
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|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
None to Mild
|
1 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
None to Severe
|
1 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Mild to None
|
12 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Mild to Mild
|
14 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Severe to None
|
18 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Severe to Mild
|
21 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Severe to Severe
|
39 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Severe to Very Severe
|
1 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Very Severe to None
|
6 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Very Severe to Mild
|
2 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Very Severe to Severe
|
4 Participants
|
|
Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Very Severe to Very Severe
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and final assessment point (Up to 48 weeks)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Investigator marked assessment of image findings of bone morphogenic abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened". The reported data were the number of participants stratified by assessment of image findings at final assessment point.
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=74 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline
Improved
|
7 Participants
|
|
Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline
Unchanged
|
66 Participants
|
|
Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline
Worsened
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and final assessment point (Up to 48 weeks)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Investigator marked assessment of image findings of trabecular bone structural abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened". The reported data were the number of participants stratified by assessment of image findings at final assessment point.
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=72 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline
Improved
|
14 Participants
|
|
Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline
Unchanged
|
57 Participants
|
|
Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline
Worsened
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and final assessment point (Up to 48 weeks)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Other Abnormalities refer to bone abnormal findings excluding bone morphogenic abnormalities and trabecular bone structural abnormalities (see Outcome Measure 5 and 6). Investigator marked assessment of image findings of other abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened". The reported data were the number of participants stratified by assessment of image findings at final assessment point.
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=39 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline
Improved
|
6 Participants
|
|
Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline
Unchanged
|
31 Participants
|
|
Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline
Worsened
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and final assessment point (Up to 48 weeks)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Percentage of changes from baseline in urinary NTX level at final assessment point (up to 48 weeks) was reported. Urinary NTX is one of bone metabolism markers.
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=42 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point
|
-51.01 Percentage of change
Standard Deviation 34.43
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SECONDARY outcome
Timeframe: Baseline and final assessment point (Up to 48 weeks)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Percentage of changes from baseline in urinary DPD level at final assessment point (up to 48 weeks) was reported. Urinary DPD is one of bone metabolism markers.
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=30 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
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|---|---|
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Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point
|
-10.01 Percentage of change
Standard Deviation 60.23
|
SECONDARY outcome
Timeframe: Baseline and final assessment point (Up to 48 weeks)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
Percentage of changes from baseline in serum BAP level at final assessment point (up to 48 weeks) was reported. Serum BAP is one of bone metabolism markers.
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=52 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
|
|---|---|
|
Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point
|
-43.57 Percentage of change
Standard Deviation 33.13
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Treatment compliance of this outcome measure refers to the percentage of participants who correctly follow medication. The reported data are percentage of participants in the classification including 4 specific degrees of treatment compliance; 90 % or more; 67 % or more and \<90 %; 25 % or more and \<67 %; less than 25 % or "unknown".
Outcome measures
| Measure |
Sodium Risedronate 17.5 mg
n=307 Participants
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
|
|---|---|
|
Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
90 % or More
|
95.11 Percentage of participants
|
|
Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
67 % or More and <90 %
|
2.61 Percentage of participants
|
|
Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
25 % or More and <67 %
|
0.65 Percentage of participants
|
|
Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
Less than 25 %
|
0.33 Percentage of participants
|
|
Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
Unknown
|
1.30 Percentage of participants
|
Adverse Events
Sodium Risedronate 17.5 mg
Serious adverse events
| Measure |
Sodium Risedronate 17.5 mg
n=307 participants at risk
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.65%
2/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Nervous system disorders
Dysarthria
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Nervous system disorders
Hemiplegia
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Gastrointestinal disorders
Ileus
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.33%
1/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
Other adverse events
| Measure |
Sodium Risedronate 17.5 mg
n=307 participants at risk
17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care.
|
|---|---|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.6%
5/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.3%
4/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
5/307 • Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms/diseases temporally associated with the use of a medicinal product reported throughout the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER