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Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance −

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ClinicalTrials.gov Identifier: NCT02106455
Recruitment Status : Completed
First Posted : April 8, 2014
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Osseous Paget's Disease
Intervention Drug: Sodium risedronate
Enrollment 315
Recruitment Details Participants took part in the study at 92 investigative sites in Japan, from 01 August 2008 to 24 October 2017.
Pre-assignment Details Participants with a historical diagnosis of osseous Paget’s disease were enrolled. Participants received interventions as part of routine medical care.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 315
Completed 307
Not Completed 8
Reason Not Completed
Case Report Form Uncollected             6
Protocol Deviation             2
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 307
Hide Baseline Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 304 participants
63.2  (12.2)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Female
134
  43.6%
Male
173
  56.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 307 participants
307
 100.0%
Pregnancy Status (not pregnant)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 134 participants
134
 100.0%
[1]
Measure Analysis Population Description: This baseline characteristic was analyzed only in female participants.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters (cm)
Number Analyzed 167 participants
159.49  (9.78)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 170 participants
59.74  (12.04)
[1]
Measure Analysis Population Description: The number analyzed is the number of participants with data available for analysis.
Classification by Treatment History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Initial Treatment
184
  59.9%
Repetitive Treatment
123
  40.1%
Treatment Duration  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
≤ 56 Days
145
  47.2%
≥ 57 Days
159
  51.8%
Unknown
3
   1.0%
Healthcare Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Outpatient
288
  93.8%
Outpatient and Inpatient
19
   6.2%
[1]
Measure Description: Participants were categorized as outpatient, inpatient, and outpatient and inpatient.
Detailed Diagnosis of Osseous Paget’s Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Monostotic Osseous Paget’s Disease
125
  40.7%
Polyostotic Osseous Paget’s Disease
176
  57.3%
Undifferentiated/Unknown
6
   2.0%
Duration of Diagnosis of Osseous Paget’s Disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
< 1 Year
106
  34.5%
1 to < 5 Years
60
  19.5%
≥ 5 Years
71
  23.1%
Unknown (Not Reported)
70
  22.8%
[1]
Measure Description: Mean duration between start of study and first time of diagnosis of Osseous Paget’s Disease was reported.
Medical Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Had No Presence of Medical Complications
105
  34.2%
Had Presence of Medical Complications
202
  65.8%
[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.
Medical History   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Had No Medical History
156
  50.8%
Had Medical History
150
  48.9%
Unknown
1
   0.3%
[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. Other medical history included all medical history except for those mentioned above.
Predisposition to Hypersensitivity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Had No Predisposition to Hypersensitivity
290
  94.5%
Had Predisposition to Hypersensitivity
9
   2.9%
Unknown
8
   2.6%
[1]
Measure Description: The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.
Family History of Osseous Paget’s Disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Had No Family History
231
  75.2%
Had Family History
7
   2.3%
Unknown
69
  22.5%
[1]
Measure Description: Reported data were the numbers of participants who had/did not have family with historical diagnosis of osseous Paget’s disease.
Experience of Fracture at Disease Site   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Had No Experiences
274
  89.3%
Had Experience
33
  10.7%
[1]
Measure Description: Reported data were the numbers of participants who had/did not have experience of fracture at disease site of osseous Paget’s disease.
Past Drug Therapy for Osseous Paget’s Disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Had No Therapies
92
  30.0%
Had Therapy
209
  68.1%
Unknown
6
   2.0%
[1]
Measure Description: 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.
Concurrent Medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 307 participants
Had No Concurrent Medication
134
  43.6%
Had Concurrent Medication
173
  56.4%
1.Primary Outcome
Title Percentage of Participants Who Had One or More Adverse Drug Reactions
Hide Description Adverse drug reaction refers to adverse events related to administered drug.
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 307
Measure Type: Number
Unit of Measure: Percentage of Participants
14.98
2.Secondary Outcome
Title Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
Hide Description Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported.
Time Frame Baseline and final assessment point (Up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 251
Mean (Standard Deviation)
Unit of Measure: Percentage of change
-72.47  (125.78)
3.Secondary Outcome
Title Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
Hide Description Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported.
Time Frame Baseline and final assessment point (Up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 251
Mean (Standard Deviation)
Unit of Measure: Percentage of change
-31.71  (30.47)
4.Secondary Outcome
Title Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
Hide Description 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)".
Time Frame Baseline and final assessment point (Up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 258
Measure Type: Count of Participants
Unit of Measure: Participants
None to None
138
  53.5%
None to Mild
1
   0.4%
None to Severe
1
   0.4%
Mild to None
12
   4.7%
Mild to Mild
14
   5.4%
Severe to None
18
   7.0%
Severe to Mild
21
   8.1%
Severe to Severe
39
  15.1%
Severe to Very Severe
1
   0.4%
Very Severe to None
6
   2.3%
Very Severe to Mild
2
   0.8%
Very Severe to Severe
4
   1.6%
Very Severe to Very Severe
1
   0.4%
5.Secondary Outcome
Title Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline
Hide Description 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.
Time Frame Baseline and final assessment point (Up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 74
Measure Type: Count of Participants
Unit of Measure: Participants
Improved
7
   9.5%
Unchanged
66
  89.2%
Worsened
1
   1.4%
6.Secondary Outcome
Title Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline
Hide Description 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.
Time Frame Baseline and final assessment point (Up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 72
Measure Type: Count of Participants
Unit of Measure: Participants
Improved
14
  19.4%
Unchanged
57
  79.2%
Worsened
1
   1.4%
7.Secondary Outcome
Title Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline
Hide Description 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.
Time Frame Baseline and final assessment point (Up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 39
Measure Type: Count of Participants
Unit of Measure: Participants
Improved
6
  15.4%
Unchanged
31
  79.5%
Worsened
2
   5.1%
8.Secondary Outcome
Title Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point
Hide Description 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.
Time Frame Baseline and final assessment point (Up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: Percentage of change
-51.01  (34.43)
9.Secondary Outcome
Title Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point
Hide Description 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.
Time Frame Baseline and final assessment point (Up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: Percentage of change
-10.01  (60.23)
10.Secondary Outcome
Title Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point
Hide Description 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.
Time Frame Baseline and final assessment point (Up to 48 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 52
Mean (Standard Deviation)
Unit of Measure: Percentage of change
-43.57  (33.13)
11.Secondary Outcome
Title Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
Hide Description 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".
Time Frame Up to 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 307
Measure Type: Number
Unit of Measure: Percentage of participants
90 % or More 95.11
67 % or More and <90 % 2.61
25 % or More and <67 % 0.65
Less than 25 % 0.33
Unknown 1.30
Time Frame Up to 48 weeks
Adverse Event Reporting Description 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.
 
Arm/Group Title Sodium Risedronate 17.5 mg
Hide Arm/Group Description 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.
All-Cause Mortality
Sodium Risedronate 17.5 mg
Affected / at Risk (%)
Total   0/307 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Sodium Risedronate 17.5 mg
Affected / at Risk (%)
Total   15/307 (4.89%) 
Cardiac disorders   
Pericardial effusion  1  1/307 (0.33%) 
Gastrointestinal disorders   
Gastroduodenal ulcer  1  1/307 (0.33%) 
Ileus  1  1/307 (0.33%) 
Hepatobiliary disorders   
Cholelithiasis  1  1/307 (0.33%) 
Hepatic function abnormal  1  1/307 (0.33%) 
Infections and infestations   
Pneumonia  1  1/307 (0.33%) 
Injury, poisoning and procedural complications   
Femur fracture  1  1/307 (0.33%) 
Tibia fracture  1  1/307 (0.33%) 
Metabolism and nutrition disorders   
Hypocalcaemia  1  2/307 (0.65%) 
Nervous system disorders   
Cerebral infarction  1  1/307 (0.33%) 
Depressed level of consciousness  1  1/307 (0.33%) 
Dysarthria  1  1/307 (0.33%) 
Hemiplegia  1  1/307 (0.33%) 
Renal and urinary disorders   
Renal impairment  1  1/307 (0.33%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sodium Risedronate 17.5 mg
Affected / at Risk (%)
Total   14/307 (4.56%) 
Gastrointestinal disorders   
Abdominal discomfort  1  4/307 (1.30%) 
Nausea  1  5/307 (1.63%) 
Metabolism and nutrition disorders   
Hypocalcaemia  1  5/307 (1.63%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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: NCT02106455     History of Changes
Other Study ID Numbers: 067-211
JapicCTI-142480 ( Registry Identifier: JapicCTI )
First Submitted: April 3, 2014
First Posted: April 8, 2014
Results First Submitted: July 31, 2018
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019