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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-142480 | Registry Identifier | JapicCTI |
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The purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets administered once daily (one tablet per dose) in patients with osseous Paget's disease for 48 weeks from baseline in daily medical practice.
This special drug use surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets 17.5 mg administered once daily (one tablet per dose) in patients with osseous Paget's disease in daily medical practice.
The usual dosage for adults is 17.5 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. For at least 30 minutes after administration, participants should avoid lying in a supine position and taking food, drink (except for water) or other oral drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 17.5 mg of sodium risedronate | 17.5 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium risedronate | Drug | Sodium risedronate tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Drug Reactions | Adverse drug reaction refers to adverse events related to administered drug. | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point | Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported. | Baseline and final assessment point (Up to 48 weeks) |
| Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point |
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Inclusion Criteria:
Exclusion Criteria:
-
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Osseous Paget's disease
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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 osseous Paget's disease were enrolled. Participants received interventions as part of routine medical care.
Participants took part in the study at 92 investigative sites in Japan, from 01 August 2008 to 24 October 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Risedronate 17.5 mg | 17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Risedronate 17.5 mg | 17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions 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 | Percentage of Participants Who Had One or More Adverse Drug Reactions | Adverse drug reaction refers to adverse events related to administered drug. | Safety Analysis Set; The safety analysis set was defined as all participants who completed the study. | Posted | Number | Percentage of Participants | Up to 48 weeks |
|
|
Up to 48 weeks
Only adverse drug reactions (ADRs) were collected in this study. ADRs are 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/diseases temporally associated with the use of a medicinal product reported throughout the study.
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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 17.5 mg | 17.5 mg of sodium risedronate was administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| 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 | Feb 15, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2018 | Feb 15, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010001 | Osteitis Deformans |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal 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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Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported. |
| Baseline and final assessment point (Up to 48 weeks) |
| Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Investigators marked severity of pain with a 4-point scale ranging from "None" to "Very Severe" (None, Mild, Severe, Very Severe) at baseline and the final assessment point. This scale was specified on the protocol of this observational study. The reported data were number of participants stratified by comparison of pain severity between baseline and final assessment point described as "None (at baseline) to Severe (at final assessment point)". | Baseline and final assessment point (Up to 48 weeks) |
| Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline | Investigator marked assessment of image findings of bone morphogenic abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened". The reported data were the number of participants stratified by assessment of image findings at final assessment point. | Baseline and final assessment point (Up to 48 weeks) |
| Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline | Investigator marked assessment of image findings of trabecular bone structural abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened". The reported data were the number of participants stratified by assessment of image findings at final assessment point. | Baseline and final assessment point (Up to 48 weeks) |
| Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline | Other Abnormalities refer to bone abnormal findings excluding bone morphogenic abnormalities and trabecular bone structural abnormalities (see Outcome Measure 5 and 6). Investigator marked assessment of image findings of other abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened". The reported data were the number of participants stratified by assessment of image findings at final assessment point. | Baseline and final assessment point (Up to 48 weeks) |
| Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point | Percentage of changes from baseline in urinary NTX level at final assessment point (up to 48 weeks) was reported. Urinary NTX is one of bone metabolism markers. | Baseline and final assessment point (Up to 48 weeks) |
| Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point | Percentage of changes from baseline in urinary DPD level at final assessment point (up to 48 weeks) was reported. Urinary DPD is one of bone metabolism markers. | Baseline and final assessment point (Up to 48 weeks) |
| Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point | Percentage of changes from baseline in serum BAP level at final assessment point (up to 48 weeks) was reported. Serum BAP is one of bone metabolism markers. | Baseline and final assessment point (Up to 48 weeks) |
| Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period | Treatment compliance of this outcome measure refers to the percentage of participants who correctly follow medication. The reported data are percentage of participants in the classification including 4 specific degrees of treatment compliance; 90 % or more; 67 % or more and <90 %; 25 % or more and <67 %; less than 25 % or "unknown". | Up to 48 weeks |
| 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 | Count of Participants | Participants |
|
| Pregnancy Status (not pregnant) | This baseline characteristic was analyzed only in female participants. | Count of Participants | 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) |
|
| Classification by Treatment History | Count of Participants | Participants |
|
| Treatment Duration | Count of Participants | Participants |
|
| Healthcare Category | Participants were categorized as outpatient, inpatient, and outpatient and inpatient. | Count of Participants | Participants |
|
| Detailed Diagnosis of Osseous Paget's Disease | Count of Participants | Participants |
|
| Duration of Diagnosis of Osseous Paget's Disease | Mean duration between start of study and first time of diagnosis of Osseous Paget's Disease was reported. | 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 | 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 |
|
| Predisposition to Hypersensitivity | The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity. | Count of Participants | Participants |
|
| Family History of Osseous Paget's Disease | Reported data were the numbers of participants who had/did not have family with historical diagnosis of osseous Paget's disease. | Count of Participants | Participants |
|
| Experience of Fracture at Disease Site | Reported data were the numbers of participants who had/did not have experience of fracture at disease site of osseous Paget's disease. | Count of Participants | Participants |
|
| Past Drug Therapy for Osseous Paget's Disease | Reported data were the numbers of participants who had/did not have received drug therapies for osseous Paget's disease in the past before the start of this study. | Count of Participants | Participants |
|
| Concurrent Medication | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point | Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported. | Efficacy assessment 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | Percentage of change | Baseline and final assessment point (Up to 48 weeks) |
|
|
|
| Secondary | Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point | Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported. | Efficacy assessment 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | Percentage of change | Baseline and final assessment point (Up to 48 weeks) |
|
|
|
| Secondary | Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Investigators marked severity of pain with a 4-point scale ranging from "None" to "Very Severe" (None, Mild, Severe, Very Severe) at baseline and the final assessment point. This scale was specified on the protocol of this observational study. The reported data were number of participants stratified by comparison of pain severity between baseline and final assessment point described as "None (at baseline) to Severe (at final assessment point)". | Efficacy assessment 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Count of Participants | Participants | Baseline and final assessment point (Up to 48 weeks) |
|
|
|
| Secondary | Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline | Investigator marked assessment of image findings of bone morphogenic abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened". The reported data were the number of participants stratified by assessment of image findings at final assessment point. | Efficacy assessment 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Count of Participants | Participants | Baseline and final assessment point (Up to 48 weeks) |
|
|
|
| Secondary | Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline | Investigator marked assessment of image findings of trabecular bone structural abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened". The reported data were the number of participants stratified by assessment of image findings at final assessment point. | Efficacy assessment 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Count of Participants | Participants | Baseline and final assessment point (Up to 48 weeks) |
|
|
|
| Secondary | Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline | Other Abnormalities refer to bone abnormal findings excluding bone morphogenic abnormalities and trabecular bone structural abnormalities (see Outcome Measure 5 and 6). Investigator marked assessment of image findings of other abnormalities at final assessment point compared with baseline as follows; "improved", "unchanged", "worsened". The reported data were the number of participants stratified by assessment of image findings at final assessment point. | Efficacy assessment 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Count of Participants | Participants | Baseline and final assessment point (Up to 48 weeks) |
|
|
|
| Secondary | Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point | Percentage of changes from baseline in urinary NTX level at final assessment point (up to 48 weeks) was reported. Urinary NTX is one of bone metabolism markers. | Efficacy assessment 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | Percentage of change | Baseline and final assessment point (Up to 48 weeks) |
|
|
|
| Secondary | Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point | Percentage of changes from baseline in urinary DPD level at final assessment point (up to 48 weeks) was reported. Urinary DPD is one of bone metabolism markers. | Efficacy assessment 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | Percentage of change | Baseline and final assessment point (Up to 48 weeks) |
|
|
|
| Secondary | Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point | Percentage of changes from baseline in serum BAP level at final assessment point (up to 48 weeks) was reported. Serum BAP is one of bone metabolism markers. | Efficacy assessment 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. The number analyzed is the number of participants with data available for analysis at the given time-point. | Posted | Mean | Standard Deviation | Percentage of change | Baseline and final assessment point (Up to 48 weeks) |
|
|
|
| Secondary | Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period | Treatment compliance of this outcome measure refers to the percentage of participants who correctly follow medication. The reported data are percentage of participants in the classification including 4 specific degrees of treatment compliance; 90 % or more; 67 % or more and <90 %; 25 % or more and <67 %; less than 25 % or "unknown". | Safety Analysis Set; The safety analysis set was defined as all participants who completed the study. | Posted | Number | Percentage of participants | Up to 48 weeks |
|
|
|
| 0 |
| 307 |
| 15 |
| 307 |
| 14 |
| 307 |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | 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.
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Mild to None |
|
| Mild to Mild |
|
| Severe to None |
|
| Severe to Mild |
|
| Severe to Severe |
|
| Severe to Very Severe |
|
| Very Severe to None |
|
| Very Severe to Mild |
|
| Very Severe to Severe |
|
| Very Severe to Very Severe |
|
| Title | Measurements |
|---|---|
|
| Less than 25 % |
|
| Unknown |
|