Trial Outcomes & Findings for Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey) (NCT NCT02089997)
NCT ID: NCT02089997
Last Updated: 2018-10-19
Results Overview
Adverse drug reactions are defined as 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 or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment.
COMPLETED
3304 participants
Up to Month 12
2018-10-19
Participant Flow
Participants took part in the study at 606 investigative sites in Japan from 27-May 2013 to 30-April 2016 .
Participants with a historical diagnosis of osteoporosis were enrolled to receive sodium risedronate 75 milligram (mg) for up to 12 months as per routine medical practice.
Participant milestones
| Measure |
Sodium Risedronate 75 mg
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Overall Study
STARTED
|
3304
|
|
Overall Study
COMPLETED
|
3058
|
|
Overall Study
NOT COMPLETED
|
246
|
Reasons for withdrawal
| Measure |
Sodium Risedronate 75 mg
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Overall Study
Case report forms uncollected
|
99
|
|
Overall Study
Protocol Violation
|
147
|
Baseline Characteristics
Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)
Baseline characteristics by cohort
| Measure |
Sodium Risedronate 75 mg
n=3058 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Age, Customized
< 65 years
|
373 Participants
n=99 Participants
|
|
Age, Customized
≥ 65 years
|
2678 Participants
n=99 Participants
|
|
Age, Customized
Unknown
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2817 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
241 Participants
n=99 Participants
|
|
Region of Enrollment
Japan
|
3058 Participants
n=99 Participants
|
|
Pregnancy Status
Pregnant
|
0 Participants
n=99 Participants
|
|
Pregnancy Status
Not pregnant
|
2329 Participants
n=99 Participants
|
|
Pregnancy Status
Unknown
|
488 Participants
n=99 Participants
|
|
Weight
< 50.0 kg
|
1050 Participants
n=99 Participants
|
|
Weight
≥ 50.0 kg
|
953 Participants
n=99 Participants
|
|
Weight
Unknown
|
1055 Participants
n=99 Participants
|
|
BMI
< 18.5kg/m^2
|
162 Participants
n=99 Participants
|
|
BMI
≥ 18.5kg/m^2 < 25.0kg/m^2
|
1108 Participants
n=99 Participants
|
|
BMI
≥ 25.0kg/m^2
|
291 Participants
n=99 Participants
|
|
BMI
Unknown
|
1497 Participants
n=99 Participants
|
|
Osteoporosis Class
Primary Osteoporosis
|
2696 Participants
n=99 Participants
|
|
Osteoporosis Class
Secondary Osteoporosis
|
232 Participants
n=99 Participants
|
|
Osteoporosis Class
Unknown
|
130 Participants
n=99 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
2658 Participants
n=99 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
151 Participants
n=99 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
249 Participants
n=99 Participants
|
|
Medical Complications
Had Presence of Medical Complications
|
2649 Participants
n=99 Participants
|
|
Medical Complications
Had No Presence of Medical Complications
|
409 Participants
n=99 Participants
|
|
Medical History（not Inclusive of a History of Fractures）
Had Medical History
|
587 Participants
n=99 Participants
|
|
Medical History（not Inclusive of a History of Fractures）
Had No Medical History
|
2264 Participants
n=99 Participants
|
|
Medical History（not Inclusive of a History of Fractures）
Unknown
|
207 Participants
n=99 Participants
|
|
Pretreatment Osteoporosis Drug
Had Treatment Drug
|
1149 Participants
n=99 Participants
|
|
Pretreatment Osteoporosis Drug
Had No Treatment Drug
|
1909 Participants
n=99 Participants
|
|
Concomitant Medication
Had Concomitant Medication
|
2512 Participants
n=99 Participants
|
|
Concomitant Medication
Had No Concomitant Medication
|
546 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12Population: Safety Analysis Set was defined as all participants who were enrolled and completed the study.
Adverse drug reactions are defined as 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 or diseases temporally associated with administration of sodium risedronate, whether or not it was considered related to the treatment.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=3058 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
|
231 Participants
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=545 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment
|
4.700 Percent change
Standard Deviation 12.118
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the femur (neck region) at end of study relative to baseline.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=393 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment
|
1.008 Percent change
Standard Deviation 5.473
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at end of study relative to baseline.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=424 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment
|
1.745 Percent change
Standard Deviation 5.180
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
BMD was measured with Dual-energy X-ray Absorptiometry. Reporting data are the change in BMD in the radius at end of study relative to baseline.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=569 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Percent Change From Baseline in Radius BMD at Final Assessment
|
1.173 Percent change
Standard Deviation 6.909
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=174 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
|
-14.024 Percent change
Standard Deviation 27.863
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=449 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment
|
-32.016 Percent change
Standard Deviation 30.219
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=128 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment
|
-19.449 Percent change
Standard Deviation 28.058
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=217 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment
|
-46.302 Percent change
Standard Deviation 30.482
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=194 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
|
-22.010 Percent change
Standard Deviation 60.634
|
SECONDARY outcome
Timeframe: Baseline and final assessment (up to Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=806 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Change From Baseline in Height
|
-0.37 Centimeter
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Final assessment (Month 12)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. Here number of participants analyzed are participants evaluable for this outcome measure.
Outcome measures
| Measure |
Sodium Risedronate 75 mg
n=2052 Participants
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Number of Participants Who Had Lumbar Backache at Final Assessment
|
663 Participants
|
Adverse Events
Sodium Risedronate 75 mg
Serious adverse events
| Measure |
Sodium Risedronate 75 mg
n=3058 participants at risk
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
2/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Vascular disorders
Hypertension
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Musculoskeletal and connective tissue disorders
Collagen disorder
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
General disorders
Death
|
0.07%
2/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
General disorders
Malaise
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
General disorders
Pyrexia
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.03%
1/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
Other adverse events
| Measure |
Sodium Risedronate 75 mg
n=3058 participants at risk
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.62%
19/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
Gastrointestinal disorders
Nausea
|
0.92%
28/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
|
General disorders
Pyrexia
|
0.78%
24/3058 • Baseline up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only ADRs were collected in this study. Participants may be represented in more than 1 category.
|
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