Sodium Risedronate Tablets - Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) -48-week Surveillance -
2019年2月15日 更新者：Takeda
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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
315
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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Osaka、日本
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Tokyo、日本
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
Osseous Paget's disease
説明
Inclusion Criteria:
- Osseous Paget's disease patients treated with sodium risedronate tablets 17.5 mg
Exclusion Criteria:
-
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
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Sodium risedronate tablets
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants Who Had One or More Adverse Drug Reactions
時間枠：Up to 48 weeks
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Adverse drug reaction refers to adverse events related to administered drug.
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Up to 48 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Changes From Baseline in Excess Serum Alkaline Phosphatase (ALP) Level at Final Assessment Point
時間枠：Baseline and final assessment point (Up to 48 weeks)
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Percentage of changes from baseline in excess serum ALP level at final assessment point (up to 48 weeks) was reported.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Serum ALP Level at Final Assessment Point
時間枠：Baseline and final assessment point (Up to 48 weeks)
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Percentage of changes from baseline in serum ALP level at final assessment point (up to 48 weeks) was reported.
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Comparison of Pain Scale Associated With Osseous Paget's Disease Between Baseline and Final Assessment Point
時間枠：Baseline and final assessment point (Up to 48 weeks)
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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)".
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Assessment of Image Findings of Bone Morphogenic Abnormalities at Final Assessment Point Compared With Baseline
時間枠：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.
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Assessment of Image Findings of Trabecular Bone Structural Abnormalities at Final Assessment Point Compared With Baseline
時間枠：Baseline and final assessment point (Up to 48 weeks)
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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.
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Baseline and final assessment point (Up to 48 weeks)
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Number of Participants Stratified by Assessment of Image Findings of Other Abnormalities at Final Assessment Point Compared With Baseline
時間枠：Baseline and final assessment point (Up to 48 weeks)
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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.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Urinary Type 1 Collagen Cross-Linked N-telopeptide (Urinary NTX) Level at Final Assessment Point
時間枠：Baseline and final assessment point (Up to 48 weeks)
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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.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Changes From Baseline in Urinary Deoxypyridinoline (Urinary DPD) Level at Final Assessment Point
時間枠：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.
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Baseline and final assessment point (Up to 48 weeks)
|
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Percentage of Changes From Baseline in Serum Bone Alkaline Phosphatase (Serum BAP) Level at Final Assessment Point
時間枠：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.
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Baseline and final assessment point (Up to 48 weeks)
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Percentage of Participants Stratified by Treatment Compliance (Medicine Adherence) During Treatment Period
時間枠：Up to 48 weeks
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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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Up to 48 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2008年8月1日
一次修了 (実際)
2017年10月24日
研究の完了 (実際)
2017年10月24日
試験登録日
最初に提出
2014年4月3日
QC基準を満たした最初の提出物
2014年4月7日
最初の投稿 (見積もり)
2014年4月8日
学習記録の更新
投稿された最後の更新 (実際)
2019年6月3日
QC基準を満たした最後の更新が送信されました
2019年2月15日
最終確認日
2019年2月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 067-211
- JapicCTI-142480 (レジストリ識別子：JapicCTI)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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Osseous Paget's Diseaseの臨床試験
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ