Phase 3 Clinical Trial of Teriparatide in Japan
2010年9月14日 更新者：Eli Lilly and Company
Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine
調査の概要
研究の種類
介入
入学 (実際)
207
段階
- フェーズ 3
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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Aichi、日本、454-0933
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukuoka、日本、811-2101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hokkaido、日本、070-0034
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyogo、日本、655-0853
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Iwate、日本、020-8505
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kagoshima、日本、890-0014
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kanagawa、日本、231-0023
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagano、日本、386-0493
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nagasaki、日本、854-0083
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oita、日本、879-7125
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Osaka、日本、555-0032
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saitama、日本、358-0007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shimane、日本、693-0021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokushima、日本、770-8503
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo、日本、163-0202
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tottori、日本、683-0853
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
55年歳以上 (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
説明
Inclusion Criteria:
- Japanese patients diagnosed with osteoporosis
- Aged 55 or older
- Patients who are at high risk for fracture
Exclusion Criteria:
- History of metabolic bone disorders other than primary osteoporosis
- History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
- Severe or chronically disabling conditions other than osteoporosis
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
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Teriparatide
20 micrograms for 104 weeks
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daily, subcutaneous
他の名前：
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プラセボコンパレーター：Placebo
Placebo for 52 weeks.
After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
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daily, subcutaneous
他の名前：
daily, subcutaneous
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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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Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
時間枠：Baseline to 52 weeks
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Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
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Baseline to 52 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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Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
時間枠：Baseline to 52 Weeks
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Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
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Baseline to 52 Weeks
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Percent Change in Bone Mineral Density (BMD) at Total Hip
時間枠：Baseline to 52 Weeks
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Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
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Baseline to 52 Weeks
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Percent Change in Bone Mineral Density (BMD) at Femoral Neck
時間枠：Baseline to 52 Weeks
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Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
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Baseline to 52 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
時間枠：Baseline to Weeks 4, 12, 24, and 52
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Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
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Baseline to Weeks 4, 12, 24, and 52
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
時間枠：Baseline to Weeks 4, 12, 24, 52
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Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
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Baseline to Weeks 4, 12, 24, 52
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
時間枠：Baseline to Weeks 4, 12, 24, 52
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Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
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Baseline to Weeks 4, 12, 24, 52
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Vertebral Fractures by Central X-ray Assessment
時間枠：Baseline through 52 weeks
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Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52).
All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment.
Number of subjects with fractures and number of fractured vertebra(e) were counted.
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Baseline through 52 weeks
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Fractures by Investigators Assessment
時間枠：Baseline through 52 Weeks
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Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment.
Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident.
Fractures were assessed to be "fragility" if they occurred without trauma.
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Baseline through 52 Weeks
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Back Pain Severity
時間枠：Baseline, Weeks 12, 24, 36, 52
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Severity of back pain at baseline, individual visits and the last measurement point.
Back pain was measured on a scale of 1 (none) to 4 (severe).
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Baseline, Weeks 12, 24, 36, 52
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Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
時間枠：Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
時間枠：Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
時間枠：Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
時間枠：Baseline, 76 Weeks, 104 Weeks
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Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
時間枠：Baseline, 76 Weeks, 104 Weeks
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Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
時間枠：Baseline, 76 Weeks, 104 Weeks
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Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
時間枠：Baseline, 76 Weeks, 104 Weeks
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Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
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Baseline, 76 Weeks, 104 Weeks
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Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
時間枠：Baseline through 104 Weeks
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Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks.
All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment.
Number of subjects with fractures and number of fractured vertebra(e) were counted.
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Baseline through 104 Weeks
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Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
時間枠：Baseline Through 104 Weeks
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Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment.
Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident.
Fractures were assessed to be "fragility" if they occurred without trauma.
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Baseline Through 104 Weeks
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Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
時間枠：Baseline, 76 Weeks, 104 Weeks
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Severity of back pain at 76 weeks and 104 weeks.
Back pain was measured on a scale of 1 (none) to 4 (severe).
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Baseline, 76 Weeks, 104 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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.
- Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015.
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
2007年1月1日
一次修了 (実際)
2008年9月1日
研究の完了 (実際)
2009年9月1日
試験登録日
最初に提出
2007年2月7日
QC基準を満たした最初の提出物
2007年2月7日
最初の投稿 (見積もり)
2007年2月9日
学習記録の更新
投稿された最後の更新 (見積もり)
2010年9月21日
QC基準を満たした最後の更新が送信されました
2010年9月14日
最終確認日
2010年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。