Trial Outcomes & Findings for 36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets (NCT NCT02106442)
NCT ID: NCT02106442
Last Updated: 2019-07-30
Results Overview
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
COMPLETED
579 participants
From baseline up to Month 36
2019-07-30
Participant Flow
Participants took part in the survey at 148 investigative sites in Japan, from 13 May 2013 to 30 April 2018.
Participants with a historical diagnosis of osteoporosis were enrolled. Participants received interventions as part of routine medical care.
Participant milestones
| Measure |
Sodium Risedronate 75 mg
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Overall Study
STARTED
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579
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Overall Study
COMPLETED
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542
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Overall Study
NOT COMPLETED
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37
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Reasons for withdrawal
| Measure |
Sodium Risedronate 75 mg
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Overall Study
Case Report Forms Uncollected
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7
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Overall Study
Protocol Deviation
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30
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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 75 mg
n=542 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Age, Continuous
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75.9 Years
STANDARD_DEVIATION 8.0 • n=541 Participants • The number analyzed is the number of participants with data available for analysis.
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Sex: Female, Male
Female
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479 Participants
n=542 Participants
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Sex: Female, Male
Male
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63 Participants
n=542 Participants
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Region of Enrollment
Japan
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542 Participants
n=542 Participants
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Height
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148.65 Centimeters (cm)
STANDARD_DEVIATION 7.88 • n=304 Participants • The number analyzed is the number of participants with data available for analysis.
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Weight
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50.37 Kilograms (kg)
STANDARD_DEVIATION 11.79 • n=348 Participants • The number analyzed is the number of participants with data available for analysis.
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BMI
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22.81 Kg/meters (m)^2
STANDARD_DEVIATION 4.81 • n=277 Participants • The number analyzed is the number of participants with data available for analysis.
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Osteoporosis Class
Primary Osteoporosis
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481 Participants
n=542 Participants
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Osteoporosis Class
Secondary Osteoporosis
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28 Participants
n=542 Participants
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Osteoporosis Class
Unknown
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33 Participants
n=542 Participants
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Duration of Diagnosis of Osteoporosis
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1.5 Years
STANDARD_DEVIATION 2.8 • n=462 Participants • The number analyzed is the number of participants with data available for analysis.
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Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
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32 Participants
n=542 Participants
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Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
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457 Participants
n=542 Participants
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Predisposition to Hypersensitivity
Unknown
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53 Participants
n=542 Participants
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Medical Complications
Had Medical Complications
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453 Participants
n=542 Participants
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Medical Complications
Had No Medical Complications
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89 Participants
n=542 Participants
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Medical History, Excluding History of Fracture
Had Medical History
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111 Participants
n=542 Participants
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Medical History, Excluding History of Fracture
Had No Medical History
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397 Participants
n=542 Participants
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Medical History, Excluding History of Fracture
Unknown
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34 Participants
n=542 Participants
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Fracture Risk Factor: Medical History of Fracture
Had Medical History
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305 Participants
n=542 Participants
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Fracture Risk Factor: Medical History of Fracture
Had No Medical History
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212 Participants
n=542 Participants
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Fracture Risk Factor: Medical History of Fracture
Unknown
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25 Participants
n=542 Participants
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Fracture Risk Factor: History of Steroid Use, Excluding Steroids for External Use
Had History of Steroid Use
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35 Participants
n=542 Participants
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Fracture Risk Factor: History of Steroid Use, Excluding Steroids for External Use
Had No History of Steroid Use
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477 Participants
n=542 Participants
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Fracture Risk Factor: History of Steroid Use, Excluding Steroids for External Use
Unknown
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30 Participants
n=542 Participants
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Fracture Risk Factor: Parental History of Femur Fracture
Had Family History of Femur Fracture
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5 Participants
n=542 Participants
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Fracture Risk Factor: Parental History of Femur Fracture
Had No Family History of Femur Fracture
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243 Participants
n=542 Participants
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Fracture Risk Factor: Parental History of Femur Fracture
Unknown
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294 Participants
n=542 Participants
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Fracture Risk Factor: Alcohol Classification
Drank >= 3 Units Daily
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27 Participants
n=542 Participants
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Fracture Risk Factor: Alcohol Classification
Drank <3 Units Daily
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356 Participants
n=542 Participants
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Fracture Risk Factor: Alcohol Classification
Unknown
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159 Participants
n=542 Participants
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Fracture Risk Factor: Smoking Classification
Never Smoked
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324 Participants
n=542 Participants
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Fracture Risk Factor: Smoking Classification
Current Smoker
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22 Participants
n=542 Participants
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Fracture Risk Factor: Smoking Classification
Ex-Smoker
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21 Participants
n=542 Participants
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Fracture Risk Factor: Smoking Classification
Unknown
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175 Participants
n=542 Participants
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Previous Medication for Osteoporosis
Had Previous Medication for Osteoporosis
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201 Participants
n=542 Participants
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Previous Medication for Osteoporosis
Had No Previous Medication for Osteoporosis
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341 Participants
n=542 Participants
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Concurrent Medication
Had Concurrent Medication
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452 Participants
n=542 Participants
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Concurrent Medication
Had No Concurrent Medication
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90 Participants
n=542 Participants
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Physical Therapy
Had Physical Therapy
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178 Participants
n=542 Participants
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Physical Therapy
Had No Physical Therapy
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364 Participants
n=542 Participants
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Other Concurrent Therapy
Had Other Concurrent Therapy
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164 Participants
n=542 Participants
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Other Concurrent Therapy
Had No Other Concurrent Therapy
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378 Participants
n=542 Participants
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Back Pain
Had Back Pain
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346 Participants
n=542 Participants
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Back Pain
Had No Back Pain
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97 Participants
n=542 Participants
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Back Pain
Unknown
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99 Participants
n=542 Participants
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PRIMARY outcome
Timeframe: From baseline up to Month 36Population: Vertebral fractures assessment population; The vertebral fractures assessment population was defined as participants who completed the survey and had evaluable vertebral fractures data at baseline and post-baseline time points. Number analyzed is the number of participants who were evaluable at each time point.
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=328 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Month 6
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5.43 Percentage of Participants
Interval 3.36 to 8.72
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Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Month 12
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7.35 Percentage of Participants
Interval 4.85 to 11.06
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Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Month 18
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7.80 Percentage of Participants
Interval 5.2 to 11.64
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Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Month 24
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8.82 Percentage of Participants
Interval 5.97 to 12.93
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Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Month 30
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9.97 Percentage of Participants
Interval 6.84 to 14.43
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Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures
Month 36
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12.58 Percentage of Participants
Interval 8.61 to 18.18
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SECONDARY outcome
Timeframe: From baseline up to Month 36Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=535 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Month 6
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1.72 Percentage of Participants
Interval 0.86 to 3.41
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Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Month 12
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2.78 Percentage of Participants
Interval 1.58 to 4.86
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Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Month 18
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3.40 Percentage of Participants
Interval 2.01 to 5.71
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Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Month 24
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4.11 Percentage of Participants
Interval 2.51 to 6.69
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Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Month 30
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6.15 Percentage of Participants
Interval 3.99 to 9.43
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Cumulative Percentage of Participants With Non-Vertebral Body Fractures
Month 36
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6.59 Percentage of Participants
Interval 4.31 to 10.01
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SECONDARY outcome
Timeframe: From baseline up to Month 36Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable at each time point.
The cumulative data was collected between baseline and Month 36, and reported for the following time points: baseline, Months 6, 12, 18, 24, 30, and 36.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=535 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Cumulative Percentage of Participants With Femur Fractures
Month 6
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0.19 Percentage of Participants
Interval 0.03 to 1.35
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Cumulative Percentage of Participants With Femur Fractures
Month 12
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0.46 Percentage of Participants
Interval 0.11 to 1.84
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Cumulative Percentage of Participants With Femur Fractures
Month 18
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0.78 Percentage of Participants
Interval 0.25 to 2.46
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Cumulative Percentage of Participants With Femur Fractures
Month 24
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1.14 Percentage of Participants
Interval 0.42 to 3.08
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Cumulative Percentage of Participants With Femur Fractures
Month 30
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1.14 Percentage of Participants
Interval 0.42 to 3.08
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Cumulative Percentage of Participants With Femur Fractures
Month 36
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1.58 Percentage of Participants
Interval 0.64 to 3.88
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
BMD was measured by dual-energy X-ray absorptiometry.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=122 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36)
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6.848 Percent Change
Standard Deviation 8.971
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
BMD was measured by dual-energy X-ray absorptiometry.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=93 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36)
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1.067 Percent Change
Standard Deviation 6.757
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
BMD was measured by dual-energy X-ray absorptiometry.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=103 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36)
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1.496 Percent Change
Standard Deviation 6.841
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
BMD was measured by dual-energy X-ray absorptiometry.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=119 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36)
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3.498 Percent Change
Standard Deviation 10.608
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=21 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
|
-15.756 Percent Change
Standard Deviation 26.386
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=97 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36)
|
-15.539 Percent Change
Standard Deviation 130.961
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=22 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36)
|
-20.023 Percent Change
Standard Deviation 23.160
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=51 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
|
|---|---|
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Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36)
|
-40.838 Percent Change
Standard Deviation 40.776
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=33 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
|
|---|---|
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Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36)
|
-25.285 Percent Change
Standard Deviation 62.112
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SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=164 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Change From Baseline in Height at Final Assessment (up to Month 36)
|
-0.82 Centimeter
Standard Deviation 1.35
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SECONDARY outcome
Timeframe: Final assessment (up to Month 36)Population: Efficacy assessment population; The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. Number analyzed is the number of participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=376 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36)
|
116 Participants
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SECONDARY outcome
Timeframe: Up to Month 36Population: 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 the administered drug.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=542 Participants
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
|
|---|---|
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Number of Participants Who Had One or More Adverse Drug Reactions
|
57 Participants
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Adverse Events
Sodium Risedronate 75 mg
Serious adverse events
| Measure |
Sodium Risedronate 75 mg
n=542 participants at risk
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
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|---|---|
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Gastrointestinal disorders
Toothache
|
0.18%
1/542 • Up to Month 36
At each visit the investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.18%
1/542 • Up to Month 36
At each visit the investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.18%
1/542 • Up to Month 36
At each visit the investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here.
|
|
Surgical and medical procedures
Hospitalisation
|
0.18%
1/542 • Up to Month 36
At each visit the investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here.
|
Other adverse events
| Measure |
Sodium Risedronate 75 mg
n=542 participants at risk
75 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants received sodium risedronate 75 mg as part of routine medical care.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
1.3%
7/542 • Up to Month 36
At each visit the investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment. Only adverse drug reactions (ADRs) were collected and reported on safety results sections here.
|
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