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Completed

NCT Number: NCT02106455

Sodium Risedronate 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.

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Key information

Conditions

Osseous Paget's Disease Bone Diseases Musculoskeletal Diseases Osteitis Deformans

Sex eligibility

All sexes

Study type

Observational

Primary location

Osaka, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Sodium risedronate

Drug

Sodium risedronate tablets

Other names: Benet 17.5mg Tablets, Actonel 17.5mg Tablets

Primary outcomes

  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 outcomes

  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".

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance -

Important dates

Study start
2008
Primary completion
2017
Study completion
2017
First posted
Apr 8, 2014
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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