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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

Brief 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.

Condition or disease Intervention/treatment
Osseous Paget's Disease Drug: Sodium risedronate

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.


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Study Type : Observational
Actual Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Prospective
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 −
Actual Study Start Date : August 1, 2008
Actual Primary Completion Date : October 24, 2017
Actual Study Completion Date : October 24, 2017


Group/Cohort Intervention/treatment
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.
Drug: Sodium risedronate
Sodium risedronate tablets
Other Names:
  • Benet 17.5mg Tablets
  • Actonel 17.5mg Tablets




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 excess serum ALP level at final assessment point (up to 48 weeks) was reported.

  2. Percentage of Changes From Baseline in Serum 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 (up to 48 weeks) was reported.

  3. 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) ]
    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)".

  4. 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) ]
    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.

  5. 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) ]
    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.

  6. 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) ]
    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.

  7. 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 NTX level at final assessment point (up to 48 weeks) was reported. Urinary NTX is one of bone metabolism markers.

  8. 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 urinary DPD level at final assessment point (up to 48 weeks) was reported. Urinary DPD is one of bone metabolism markers.

  9. 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 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.

  10. Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period [ Time Frame: Up to 48 weeks ]
    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".



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Osseous Paget's disease
Criteria

Inclusion Criteria:

  • Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106455


Locations
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Japan
Osaka, Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] June 2, 2017
Statistical Analysis Plan  [PDF] March 30, 2018


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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02106455     History of Changes
Other Study ID Numbers: 067-211
JapicCTI-142480 ( Registry Identifier: JapicCTI )
First Posted: April 8, 2014    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Pharmacological theapy
Additional relevant MeSH terms:
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Osteitis Deformans
Bone Diseases
Musculoskeletal Diseases
Risedronic Acid
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents