Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
2009年2月13日 更新者：Eli Lilly and Company
Comparison of the Effects of Teriparatide With Those of Alendronate Sodium on Lumbar Spine Bone Mineral Density in Glucocorticoid-Induced Osteoporosis
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures.
Glucocorticoids (such as prednisone) are prescribed to treat a large number of conditions such as arthritis and asthma.
When taken for several months or longer, glucocorticoids can cause bone loss and lead to a form of osteoporosis called "glucocorticoid-induced osteoporosis."
This study compared the effects of teriparatide, the study drug, with alendronate, an approved drug for treating glucocorticoid-induced osteoporosis.
調査の概要
研究の種類
介入
入学 (実際)
428
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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California
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Loma Linda、California、アメリカ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Palo Alto、California、アメリカ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Colorado
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Aurora、Colorado、アメリカ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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North Dakota
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Fargo、North Dakota、アメリカ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Jamestown、North Dakota、アメリカ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Wisconsin
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Milwaukee、Wisconsin、アメリカ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Graz、オーストリア
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Vienna、オーストリア
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Aarhus、デンマーク
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Oslo、ノルウェー
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Carolina、プエルトリコ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Ponce、プエルトリコ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Brussels、ベルギー
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Gent、ベルギー
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
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Leuven、ベルギー
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 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
21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:
- Men or women age 21 years or older
- Taking on average 5.0 mg/day prednisone or equivalent for at least 3 months prior to screening
Exclusion Criteria:
- Taking bisphosphonates within past 6 months
- More than 30 micrograms/day of estradiol or equivalent in past 3 months
- History of alcoholism or drug abuse in past year
- Pregnant women or nursing mothers
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：A
Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
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20 micrograms/day, injection, 36 months
他の名前：
Oral placebo, daily, 36 months
Injection placebo, daily, 36 months
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アクティブコンパレータ：B
Alendronate 10 mg/day oral plus injection placebo, 36 months
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Oral placebo, daily, 36 months
Injection placebo, daily, 36 months
10 mg/day, oral, 36 months
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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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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)
時間枠：18 month endpoint
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change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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18 month endpoint
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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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Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset
時間枠：18 month endpoint
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change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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18 month endpoint
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Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
時間枠：3, 6, 12, 18, 24, 36 months
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change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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3, 6, 12, 18, 24, 36 months
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Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset
時間枠：3, 6, 12, and 18 months
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change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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3, 6, 12, and 18 months
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Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined
時間枠：24 and 36 months and Endpoint at 36 months
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change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)
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24 and 36 months and Endpoint at 36 months
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Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
時間枠：18, 24, 36 months, and 18 and 36 month endpoints
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change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
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18, 24, 36 months, and 18 and 36 month endpoints
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Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
時間枠：18, 24, 36 months, and 18 and 36 month endpoints
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change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
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18, 24, 36 months, and 18 and 36 month endpoints
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Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined
時間枠：12, 18, 24, and 36 months
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change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)
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12, 18, 24, and 36 months
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Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined
時間枠：12, 18, 24, and 36 months
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change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)
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12, 18, 24, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen
時間枠：1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen
時間枠：1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase
時間枠：1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments
時間枠：1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin
時間枠：1, 6, 18, and 36 months
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1, 6, 18, and 36 months
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Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures
時間枠：36 months
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Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.
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36 months
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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
- Saag KG, Agnusdei D, Hans D, Kohlmeier LA, Krohn KD, Leib ES, MacLaughlin EJ, Alam J, Simonelli C, Taylor KA, Marcus R. Trabecular Bone Score in Patients With Chronic Glucocorticoid Therapy-Induced Osteoporosis Treated With Alendronate or Teriparatide. Arthritis Rheumatol. 2016 Sep;68(9):2122-8. doi: 10.1002/art.39726.
- Devogelaer JP, Adler RA, Recknor C, See K, Warner MR, Wong M, Krohn K. Baseline glucocorticoid dose and bone mineral density response with teriparatide or alendronate therapy in patients with glucocorticoid-induced osteoporosis. J Rheumatol. 2010 Jan;37(1):141-8. doi: 10.3899/jrheum.090411. Epub 2009 Nov 16.
- Saag KG, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or alendronate in glucocorticoid-induced osteoporosis. N Engl J Med. 2007 Nov 15;357(20):2028-39. doi: 10.1056/NEJMoa071408.
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
2002年11月1日
一次修了 (実際)
2006年7月1日
研究の完了 (実際)
2008年1月1日
試験登録日
最初に提出
2003年1月13日
QC基準を満たした最初の提出物
2003年1月13日
最初の投稿 (見積もり)
2003年1月14日
学習記録の更新
投稿された最後の更新 (見積もり)
2009年3月12日
QC基準を満たした最後の更新が送信されました
2009年2月13日
最終確認日
2009年2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。