Osseous Paget's DiseaseNCT02106455
Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
An observational study of Osseous Paget's Disease, run by Takeda at 2 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osseous Paget's Disease
- What is being tested?
- Sodium risedronate
- Type of treatment
- Pill or oral medicine
- How many people
- 315 participants
- Where
- 2 sitesJapan
- Study dates
- 1 Aug 2008to 24 Oct 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Osseous Paget's disease
Who may be able to join
- Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance -
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.
Read the detailed description
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.
- Conditions
- Osseous Paget's Disease
- Being tested
- Sodium risedronate
- Keywords
- Pharmacological theapy
- Medical subject headings
- Osteitis Deformans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium risedronateDrug
Also called Benet 17.5mg Tablets, Actonel 17.5mg Tablets
Sodium risedronate tablets
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium risedronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Had One or More Adverse Drug Reactions
Adverse drug reaction refers to adverse events related to administered drug.
Measured: Up to 48 weeks
Secondary outcomes (10)
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.
Measured: Baseline and final assessment point (Up to 48 weeks)
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.
Measured: 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)".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study start1 Aug 2008
- Primary completion24 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osseous Paget's DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106455
- Sponsor's protocol ID
- 067-211
- Other IDs
- JapicCTI-142480
- Status last verified
- Feb 2019
- First submitted
- 3 Apr 2014
- Last updated
- 3 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance -
- ClinicalTrials.gov ID
- NCT02106455
- Acronym / sponsor ID
- 067-211
- Conditions
- Osseous Paget's Disease
- Keywords
- Pharmacological theapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2008 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Posted 3 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 17.5 mg of sodium risedronate | – | Drug: Sodium risedronate17.5 mg of sodium risedronate is administered orally with a sufficient volume (approximately 180 mL) of water once daily after waking for 8 consecutive weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Osseous Paget's disease
Key inclusion criteria (1 listed)
- Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium risedronateAlso: Benet 17.5mg Tablets, Actonel 17.5mg TabletsSodium risedronate tablets | Drug | 17.5 mg of sodium risedronate |
Primary outcome
Percentage of Participants Who Had One or More Adverse Drug Reactions
Time frame: Up to 48 weeks
Adverse drug reaction refers to adverse events related to administered drug.
10 secondary outcomes
Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
Time frame: Baseline and final assessment point (Up to 48 weeks)
Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and final assessment point (Up to 48 weeks)
Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point
Time frame: 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
Time frame: Baseline and final assessment point (Up to 48 weeks)
Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
Time frame: Up to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osseous Paget's Disease, run by Takeda at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Had One or More Adverse Drug Reactions (time frame: Up to 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.