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Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month Treatment Survey)

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ClinicalTrials.gov Identifier: NCT02089997
Recruitment Status : Completed
First Posted : March 18, 2014
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Osteoporosis
Intervention Drug: Sodium Risedronate
Enrollment 3304
Recruitment Details Participants took part in the study at 606 investigative sites in Japan from 27-May 2013 to 30-April 2016 .
Pre-assignment Details 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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Period Title: Overall Study
Started 3304
Completed 3058
Not Completed 246
Reason Not Completed
Case report forms uncollected             99
Protocol Violation             147
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Baseline Participants 3058
Hide Baseline Analysis Population Description
Safety Analysis Set was defined as all participants who were enrolled and completed the study.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
< 65 years 373
≥ 65 years 2678
Unknown 7
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3058 participants
Female
2817
  92.1%
Male
241
   7.9%
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 3058 participants
3058
[1]
Measure Description: All participants were enrolled in Japan.
Pregnancy Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
Pregnant 0
Not pregnant 2329
Unknown 488
[1]
Measure Description: This baseline characteristic was analyzed only in female participants.
Weight  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
< 50.0 kg 1050
≥ 50.0 kg 953
Unknown 1055
BMI   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
< 18.5kg/m^2 162
≥ 18.5kg/m^2 < 25.0kg/m^2 1108
≥ 25.0kg/m^2 291
Unknown 1497
[1]
Measure Description: Body Mass Index = weight (kg)/[height (m)^2]
Osteoporosis Class  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
Primary Osteoporosis 2696
Secondary Osteoporosis 232
Unknown 130
Predisposition to Hypersensitivity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
Had No Predisposition to Hypersensitivity 2658
Had Predisposition to Hypersensitivity 151
Unknown 249
Medical Complications   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
Had Presence of Medical Complications 2649
Had No Presence of Medical Complications 409
[1]
Measure Description: Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. Participants may be represented in more than 1 category.
Medical History(not Inclusive of a History of Fractures)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
Had Medical History 587
Had No Medical History 2264
Unknown 207
[1]
Measure Description: Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history and Bone Fractures were out of scope for Medical history in this study. Other medical history included all medical history except for those mentioned above. Participants may be represented in more than 1 category.
Pretreatment Osteoporosis Drug  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
Had Treatment Drug 1149
Had No Treatment Drug 1909
Concomitant Medication  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3058 participants
Had Concomitant Medication 2512
Had No Concomitant Medication 546
1.Primary Outcome
Title Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs)
Hide Description 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.
Time Frame Up to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set was defined as all participants who were enrolled and completed the study.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 3058
Measure Type: Number
Unit of Measure: Participants
231
2.Secondary Outcome
Title Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment
Hide Description 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.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 545
Mean (Standard Deviation)
Unit of Measure: Percent change
4.700  (12.118)
3.Secondary Outcome
Title Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment
Hide Description 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.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 393
Mean (Standard Deviation)
Unit of Measure: Percent change
1.008  (5.473)
4.Secondary Outcome
Title Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment
Hide Description 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.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 424
Mean (Standard Deviation)
Unit of Measure: Percent change
1.745  (5.180)
5.Secondary Outcome
Title Percent Change From Baseline in Radius BMD at Final Assessment
Hide Description 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.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 569
Mean (Standard Deviation)
Unit of Measure: Percent change
1.173  (6.909)
6.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
Hide Description Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 174
Mean (Standard Deviation)
Unit of Measure: Percent change
-14.024  (27.863)
7.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment
Hide Description Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 449
Mean (Standard Deviation)
Unit of Measure: Percent change
-32.016  (30.219)
8.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment
Hide Description Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 128
Mean (Standard Deviation)
Unit of Measure: Percent change
-19.449  (28.058)
9.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment
Hide Description Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 217
Mean (Standard Deviation)
Unit of Measure: Percent change
-46.302  (30.482)
10.Secondary Outcome
Title Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment
Hide Description Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule.
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 194
Mean (Standard Deviation)
Unit of Measure: Percent change
-22.010  (60.634)
11.Secondary Outcome
Title Change From Baseline in Height
Hide Description [Not Specified]
Time Frame Baseline and final assessment (up to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 806
Mean (Standard Deviation)
Unit of Measure: Centimeter
-0.37  (1.10)
12.Secondary Outcome
Title Number of Participants Who Had Lumbar Backache at Final Assessment
Hide Description [Not Specified]
Time Frame Final assessment (Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description:
Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
Overall Number of Participants Analyzed 2052
Measure Type: Number
Unit of Measure: Participants
663
Time Frame Baseline up to Month 12
Adverse Event Reporting Description 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.
 
Arm/Group Title Sodium Risedronate 75 mg
Hide Arm/Group Description Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months.
All-Cause Mortality
Sodium Risedronate 75 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Risedronate 75 mg
Affected / at Risk (%)
Total   15/3058 (0.49%) 
Cardiac disorders   
Cardiac hypertrophy  1  1/3058 (0.03%) 
Aortic valve stenosis  1  1/3058 (0.03%) 
General disorders   
Death  1 [1]  2/3058 (0.07%) 
Malaise  1  1/3058 (0.03%) 
Pyrexia  1  1/3058 (0.03%) 
Infections and infestations   
Pneumonia  1  1/3058 (0.03%) 
Injury, poisoning and procedural complications   
Femoral neck fracture  1  1/3058 (0.03%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/3058 (0.03%) 
Collagen disorder  1  1/3058 (0.03%) 
Nervous system disorders   
Cerebral haemorrhage  1  2/3058 (0.07%) 
Renal and urinary disorders   
Renal impairment  1  1/3058 (0.03%) 
Vascular disorders   
Hypertension  1  1/3058 (0.03%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
[1]
The reasons of events are not determined because assessment findings were insufficient to specify the reason.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Sodium Risedronate 75 mg
Affected / at Risk (%)
Total   71/3058 (2.32%) 
Gastrointestinal disorders   
Diarrhoea  1  19/3058 (0.62%) 
Nausea  1  28/3058 (0.92%) 
General disorders   
Pyrexia  1  24/3058 (0.78%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02089997     History of Changes
Other Study ID Numbers: 178-001
JapicCTI-142463 ( Registry Identifier: JapicCTI )
JapicCTI-R171017 ( Other Identifier: JapicCTI )
First Submitted: March 14, 2014
First Posted: March 18, 2014
Results First Submitted: July 27, 2017
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018