Trial · NCT02106455
Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
NCT02106455, Completed, Takeda; results first posted 2019-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -. Trials, record NCT02106455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02106455
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
- NCT number
- NCT02106455
- Status
- Completed
- Enrollment
- 315 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Osseous Paget's Disease
- Interventions
- Sodium risedronate
- First posted
- 2014-04-08
- Last updated
- 2019-06-03
- Results first posted
- 2019-06-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Had One or More Adverse Drug Reactions | Up to 48 weeks | Adverse drug reaction refers to adverse events related to administered drug. |
| Secondary | Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported. |
| Secondary | Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported. |
| Secondary | Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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)". |
| Secondary | Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline | Baseline and final assessment point (Up to 48 weeks) | 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. |
| Secondary | Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline | Baseline and final assessment point (Up to 48 weeks) | 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. |
| Secondary | Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline | Baseline and final assessment point (Up to 48 weeks) | 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. |
| Secondary | Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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. |
| Secondary | Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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. |
| Secondary | Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Had One or More Adverse Drug Reactions | Up to 48 weeks | Safety Analysis Set; The safety analysis set was defined as all participants who completed the study. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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. | Percentage of change | MEAN |
| SECONDARY | Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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. | Percentage of change | MEAN |
| SECONDARY | Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline | Baseline and final assessment point (Up to 48 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline | Baseline and final assessment point (Up to 48 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline | Baseline and final assessment point (Up to 48 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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. | Percentage of change | MEAN |
| SECONDARY | Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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. | Percentage of change | MEAN |
| SECONDARY | Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point | Baseline and final assessment point (Up to 48 weeks) | 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. | Percentage of change | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Had One or More Adverse Drug Reactions | Sodium Risedronate 17.5 mg | 14.98 | Percentage of Participants | ||
| Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point | Sodium Risedronate 17.5 mg | -72.47 | Standard Deviation 125.78 | Percentage of change | |
| Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point | Sodium Risedronate 17.5 mg | -31.71 | Standard Deviation 30.47 | Percentage of change | |
| Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Sodium Risedronate 17.5 mg | None to None | 138 | Participants | |
| Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Sodium Risedronate 17.5 mg | None to Mild | 1 | Participants | |
| Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Sodium Risedronate 17.5 mg | None to Severe | 1 | Participants | |
| Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Sodium Risedronate 17.5 mg | Mild to None | 12 | Participants | |
| Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Sodium Risedronate 17.5 mg | Mild to Mild | 14 | Participants | |
| Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Sodium Risedronate 17.5 mg | Severe to None | 18 | Participants | |
| Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point | Sodium Risedronate 17.5 mg | Severe to Mild | 21 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sodium Risedronate 17.5 mg | 315 | |
| Overall Study | COMPLETED | Sodium Risedronate 17.5 mg | 307 | |
| Overall Study | NOT COMPLETED | Sodium Risedronate 17.5 mg | 8 |
Source ClinicalTrials.gov
Adverse events17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypocalcaemia | Metabolism and nutrition disorders | Sodium Risedronate 17.5 mg | 5 | 307 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Sodium Risedronate 17.5 mg | 4 | 307 | |
| other | Nausea | Gastrointestinal disorders | Sodium Risedronate 17.5 mg | 5 | 307 | |
| serious | Pneumonia | Infections and infestations | Sodium Risedronate 17.5 mg | 1 | 307 | |
| serious | Hypocalcaemia | Metabolism and nutrition disorders | Sodium Risedronate 17.5 mg | 2 | 307 | |
| serious | Cerebral infarction | Nervous system disorders | Sodium Risedronate 17.5 mg | 1 | 307 | |
| serious | Depressed level of consciousness | Nervous system disorders | Sodium Risedronate 17.5 mg | 1 | 307 | |
| serious | Dysarthria | Nervous system disorders | Sodium Risedronate 17.5 mg | 1 | 307 | |
| serious | Pericardial effusion | Cardiac disorders | Sodium Risedronate 17.5 mg | 1 | 307 | |
| serious | Hemiplegia | Nervous system disorders | Sodium Risedronate 17.5 mg | 1 | 307 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sodium Risedronate 17.5 mg | 0 | 307 |
| Total, other adverse events | Sodium Risedronate 17.5 mg | 14 | 307 |
| Total, serious adverse events | Sodium Risedronate 17.5 mg | 15 | 307 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02106455
GET https://conductscience.org/api/trials/v1/NCT02106455/results?page=2