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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142479 | Registry Identifier | JapicCTI |
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The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.
This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Risedronate 75 mg | 75 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking. Participants receive sodium risedronate 75 mg as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium risedronate | Drug | Sodium risedronate tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | 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. | From baseline up to Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percentage of Participants With Non-Vertebral Body Fractures | 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. | From baseline up to Month 36 |
| Cumulative Percentage of Participants With Femur Fractures |
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Inclusion Criteria:
Osteoporosis patients who meet all the following 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 | |||||
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Participants with a historical diagnosis of osteoporosis were enrolled. Participants received interventions as part of routine medical care.
Participants took part in the survey at 148 investigative sites in Japan, from 13 May 2013 to 30 April 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The number analyzed is the number of participants with data available for analysis. |
| 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 | Cumulative Percentage of Participants With New or Worsening Vertebral Body Fractures | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From baseline up to Month 36 |
|
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.
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA/J ver. 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA/J ver. 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 2, 2017 | Apr 23, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2017 | Apr 23, 2019 | SAP_001.pdf |
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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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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. |
| From baseline up to Month 36 |
| Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | Baseline and final assessment (up to Month 36) |
| Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | Baseline and final assessment (up to Month 36) |
| Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | Baseline and final assessment (up to Month 36) |
| Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | Baseline and final assessment (up to Month 36) |
| Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) |
| Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) |
| Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) |
| Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) |
| Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) |
| Change From Baseline in Height at Final Assessment (up to Month 36) | Baseline and final assessment (up to Month 36) |
| Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36) | Final assessment (up to Month 36) |
| Number of Participants Who Had One or More Adverse Drug Reactions | Adverse drug reaction refers to adverse events related to the administered drug. | Up to Month 36 |
| Tokyo |
| Japan |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
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| BMI | Body Mass Index = weight (kg)/[height (m)^2] | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kg/meters (m)^2 |
|
| Osteoporosis Class | Count of Participants | Participants |
|
| Duration of Diagnosis of Osteoporosis | Mean duration from the first time of diagnosis of osteoporosis to the start of the study was reported. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Years |
|
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | 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. | Count of Participants | Participants |
|
| Medical History, Excluding History of Fracture | 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. Other medical history included all medical history except for those mentioned above. | Count of Participants | Participants |
|
| Fracture Risk Factor: Medical History of Fracture | Count of Participants | Participants |
|
| Fracture Risk Factor: History of Steroid Use, Excluding Steroids for External Use | Count of Participants | Participants |
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| Fracture Risk Factor: Parental History of Femur Fracture | Count of Participants | Participants |
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| Fracture Risk Factor: Alcohol Classification | Count of Participants | Participants |
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| Fracture Risk Factor: Smoking Classification | Count of Participants | Participants |
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| Previous Medication for Osteoporosis | Count of Participants | Participants |
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| Concurrent Medication | Count of Participants | Participants |
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| Physical Therapy | Count of Participants | Participants |
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| Other Concurrent Therapy | Other concurrent therapy included diet therapy, exercise therapy, and nerve block. | Count of Participants | Participants |
|
| Back Pain | Count of Participants | Participants |
|
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| Secondary | Cumulative Percentage of Participants With Non-Vertebral Body Fractures | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From baseline up to Month 36 |
|
|
|
| Secondary | Cumulative Percentage of Participants With Femur Fractures | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From baseline up to Month 36 |
|
|
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| Secondary | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and final assessment (up to Month 36) |
|
|
|
| Secondary | Percent Change From Baseline in Femur Neck BMD at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and final assessment (up to Month 36) |
|
|
|
| Secondary | Percent Change From Baseline in Total Proximal Femur BMD at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and final assessment (up to Month 36) |
|
|
|
| Secondary | Percent Change From Baseline in Radius BMD at Final Assessment (up to Month 36) | BMD was measured by dual-energy X-ray absorptiometry. | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and final assessment (up to Month 36) |
|
|
|
| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and final assessment (up to Month 36) |
|
|
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| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Final Assessment (up to Month 36) | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and final assessment (up to Month 36) |
|
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| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Bone-type Alkaline Phosphatase (BAP) at Final Assessment (up to Month 36) | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and final assessment (up to Month 36) |
|
|
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| Secondary | Percent Change From Baseline in Bone Metabolism Markers Serum Procollagen 1 N-terminal Peptide (P1NP) at Final Assessment (up to Month 36) | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and final assessment (up to Month 36) |
|
|
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| Secondary | Percent Change From Baseline in Bone Metabolism Markers Urinary Type 1 Collagen Cross-linked N-telopeptide (NTX) at Final Assessment (up to Month 36) | 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. | Posted | Mean | Standard Deviation | Percent Change | Baseline and final assessment (up to Month 36) |
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| Secondary | Change From Baseline in Height at Final Assessment (up to Month 36) | 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. | Posted | Mean | Standard Deviation | Centimeter | Baseline and final assessment (up to Month 36) |
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| Secondary | Number of Participants Who Had Lumbar Backache at Final Assessment (up to Month 36) | 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. | Posted | Count of Participants | Participants | Final assessment (up to Month 36) |
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| Secondary | Number of Participants Who Had One or More Adverse Drug Reactions | Adverse drug reaction refers to adverse events related to the administered drug. | Safety Analysis Set; The safety analysis set was defined as all participants who completed the study. | Posted | Count of Participants | Participants | Up to Month 36 |
|
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| 0 |
| 542 |
| 4 |
| 542 |
| 7 |
| 542 |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA/J ver. 21.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA/J ver. 21.0 | Systematic Assessment |
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| Hospitalisation | Surgical and medical procedures | MedDRA/J ver. 21.0 | Systematic Assessment |
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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 |
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| Month 36 |
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| Month 36 |
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