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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142463 | Registry Identifier | JapicCTI | |
| JapicCTI-R171017 | Other Identifier | JapicCTI |
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The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen
This surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (Benet 75 mg Tablets) as well as to evaluate the status of treatment compliance in osteoporosis patients in daily medical practice.
The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. For at least 30 minutes after administration, patients should avoid lying in a supine position and should avoid taking food, drink (except for water) or other oral drugs. For more details, see the "Precautions related to dosage and administration" section of the package insert.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 75 mg of sodium risedronate | 75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Risedronate | Drug | Sodium risedronate tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | 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. | Up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment | 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. | Baseline and final assessment (up to Month 12) |
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Inclusion Criteria:
Exclusion Criteria:
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Osteoporosis
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
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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.
Participants took part in the study at 606 investigative sites in Japan from 27-May 2013 to 30-April 2016 .
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Risedronate 75 mg | Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set was defined as all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Risedronate 75 mg | Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experience at Least One Adverse Drug Reactions (ADRs) | 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. | Safety Analysis Set was defined as all participants who were enrolled and completed the study. | Posted | Number | Participants | Up to Month 12 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Risedronate 75 mg | Sodium risedronate 75 mg, tablet, orally, once monthly for up to 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment | 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. | Baseline and final assessment (up to Month 12) |
| Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment | 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. | Baseline and final assessment (up to Month 12) |
| Percent Change From Baseline in Radius BMD at Final Assessment | 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. | Baseline and final assessment (up to Month 12) |
| Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) |
| Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) |
| Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) |
| Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) |
| Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule. | Baseline and final assessment (up to Month 12) |
| Change From Baseline in Height | Baseline and final assessment (up to Month 12) |
| Number of Participants Who Had Lumbar Backache at Final Assessment | Final assessment (Month 12) |
| Tokyo |
| Japan |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | All participants were enrolled in Japan. | Number | Participants |
|
| Pregnancy Status | This baseline characteristic was analyzed only in female participants. | Number | Participants |
|
| Weight | Number | Participants |
|
| BMI | Body Mass Index = weight (kg)/[height (m)^2] | Number | Participants |
|
| Osteoporosis Class | Number | Participants |
|
| Predisposition to Hypersensitivity | Number | Participants |
|
| Medical Complications | 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. | Number | Participants |
|
| Medical History（not Inclusive of a History of Fractures） | 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. | Number | Participants |
|
| Pretreatment Osteoporosis Drug | Number | Participants |
|
| Concomitant Medication | Number | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment | 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Percent Change From Baseline in Femur (Neck Region) BMD at Final Assessment | 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Percent Change From Baseline in Femur (Total Proximal Femur) BMD at Final Assessment | 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Percent Change From Baseline in Radius BMD at Final Assessment | 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. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment | Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment | Urine samples for urinary bone turnover markers were collected at specified visits according to the study schedule. | 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. | Posted | Mean | Standard Deviation | Percent change | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Change From Baseline in Height | 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. | Posted | Mean | Standard Deviation | Centimeter | Baseline and final assessment (up to Month 12) |
|
|
|
| Secondary | Number of Participants Who Had Lumbar Backache at Final Assessment | 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. | Posted | Number | Participants | Final assessment (Month 12) |
|
|
|
| 15 |
| 3,058 |
| 71 |
| 3,058 |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cardiac hypertrophy | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Aortic valve stenosis | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Collagen disorder | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 14.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
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| Malaise | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
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.
| D009750 |
| Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |