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An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids

2020年9月1日 更新者：Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Placebo Controlled Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly Compared to Placebo in Osteoporotic Children Treated With Glucocorticoids.

This study was designed to evaluate the efficacy and safety of zoledronic acid compared to placebo in osteoporotic children treated with glucocorticoids

調査の概要

状態

完了

条件

介入・治療

詳細な説明

In March 2017, Novartis stopped enrollment as the study was not feasible to be conducted due to low enrollment and other recruitment challenges. Patients receiving the treatment continued to receive the treatment per protocol.

研究の種類

介入

入学 (実際)

34

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

  • イギリス
      • Manchester、イギリス、M14 0JH
        • Novartis Investigative Site
    • Birmingham
      • West Midlands、Birmingham、イギリス、B4 6NH
        • Novartis Investigative Site
  • オーストラリア
    • New South Wales
      • Westmead、New South Wales、オーストラリア、2145
        • Novartis Investigative Site
  • カナダ
    • British Columbia
      • Vancouver、British Columbia、カナダ、V6H 3V4
        • Novartis Investigative Site
    • Manitoba
      • Winnipeg、Manitoba、カナダ、R3E 0Z2
        • Novartis Investigative Site
    • Ontario
      • Ottawa、Ontario、カナダ、K1H 8L1
        • Novartis Investigative Site
    • Quebec
      • Montreal、Quebec、カナダ、H3T 1C5
        • Novartis Investigative Site
      • Montreal、Quebec、カナダ、H3H 1P3
        • Novartis Investigative Site
  • ハンガリー
      • Budapest、ハンガリー、1085
        • Novartis Investigative Site
  • ロシア連邦
      • Moscow、ロシア連邦、119991
        • Novartis Investigative Site
      • Saint Petersburg、ロシア連邦、195067
        • Novartis Investigative Site
  • 南アフリカ
    • Gauteng
      • Soweto、Gauteng、南アフリカ、2013
        • Novartis Investigative Site

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

5年～17年 (子)

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

Key Inclusion Criteria:

  • A diagnosis of chronic rheumatologic conditions or inflammatory bowel disease or Duchenne muscular dystrophy requiring systemic glucocorticoids (i.v. or oral) within 12 months prior to screening
  • Lumbar Spine BMDZ-score of -0.5 or worse
  • Evidence of at least at least 1 vertebral compression fracture of Genant Grade 1 or higher (or radiographic signs of vertebral fracture) within 1 month from Screening visit OR One or more, low-trauma, lower extremity long-bone fracture which occurred sometime within the 2 years PRECEDING enrollment in the study OR Two or more, low-trauma, upper extremity long-bone fractures which occurred sometime within the 2 years PRECEDING enrollment in the study
  • Consent/assent to study participation

Key Exclusion Criteria:

  • History of primary bone disease (OI, Idiopathic Juvenile Osteoporosis, Rickets/Osteomalacia)
  • Any medical condition that might have interfered with the evaluation of lumbar spine BMD, such as severe scoliosis or spinal fusion. Patients with less than 3 evaluable vertebrae by Dual Energy X-ray Absorptiometry (DXA) evaluation in the region of interest lumbar 1 (L1) to lumbar 4 (L4),
  • Hypocalcemia and hypophosphatemia
  • Serum 25-hydroxy vitamin D concentrations of <20 ng/mL or <50 nmol/L
  • estimated glomerular filtration rate (GFR) <60 mL/min/1.73 m2
  • serum creatinine increase between Visit 1 and Visit 2 >0.5 mg/dL (44.2 μmol/L)
  • Uncontrolled symptoms of cardiac failure or arrhythmia
  • Any prior use of bisphosphonates, or high dose sodium fluoride

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
実験的：ゾレドロン酸
年に 2 回、ゾレドロン酸 0.05 mg/kg (最大 5 mg) の静脈内注入 (少なくとも 30 分)
薬：ゾレドロン酸
点滴静注
プラセボコンパレーター：Placebo
Twice yearly i.v of infusion of Placebo (similar dosing as active drug)
薬：プラセボ
静脈内注入

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
Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 12
時間枠：Month 12
Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor before first treatment and at Month 12. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from baseline indicated an improvement in condition.
Month 12

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 6
時間枠：Month 6
Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor before first treatment and at Month 6. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from baseline indicated an improvement in condition.
Month 6
Mean Change From Baseline in Lumbar Spine BMC at Month 6 and 12
時間枠：Month 6, Month 12
Lumbar Spine BMC was determined by the central imaging vendor before first treatment and at Months 6 and 12. The methods to be used to measure BMC were described in the respective DXA Manuals.
Month 6, Month 12
Mean Change From Baseline in Total Body BMC at Month 6 and 12
時間枠：Month 6, Month 12
Total body BMC was all determined by the central imaging vendor before first treatment and at Months 6 and 12. The methods to be used to measure BMC were described in the respective DXA Manuals.
Month 6, Month 12
Mean Change From Baseline in Serum P1NP at Months 6 and 12
時間枠：Month 6, Month 12
Serum Procollagen type 1 amino-terminal propeptide (P1NP) was collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
Month 6, Month 12
Mean Change From Baseline in BSAP at Months 6 and 12
時間枠：Month 6, Month 12
Bone specific alkaline phosphatase (BSAP) were collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
Month 6, Month 12
Mean Change From Baseline in Serum NTX at Months 6 and 12
時間枠：Month 6, Month 12
Serum Cross linked N-telopeptide (NTX) were collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
Month 6, Month 12
Mean Change From Baseline in Serum TRAP-5b at Months 6 and 12
時間枠：Month 6, Month 12
Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP 5b) was collected before first treatment (baseline) and at Months 6 and Month 12 according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory.
Month 6, Month 12
Number of Participants With New Vertebral Fractures at Month 12
時間枠：Month 12
New vertebral fractures were defined as fractures of Genant Grade 1 or higher that occurred at lumbar or thoracic spine from first dose infusion to the end of the study.
Month 12
Mean Change From Baseline in Vertebral Morphometry at Month 12
時間枠：Month 12
Vertebral morphometry (or concave index) was calculated using the average ratio between mid-height and posterior height from L1 to L4 and performed by a central reader.
Month 12
Percentage of Patients With Reduction in Pain at Months 3, 6, 9 and 12
時間枠：Month 3, Month 6, Month 9 and Month 12
Pain was evaluated at each visit (in office and telephone visit) at randomization, Months 3, 6, 9 and 12 using the Faces Pain Scale-Revised (FPS-R). Children were selecting the face that best fits their pain. The pain score ranged from 0 (No Pain) to 10 (Very Much Pain). The reduction in pain from baseline by visit was evaluated based on whether or not patients had a decrease in their FPS-R from baseline. If pain remained the same or worsened from baseline a patient was classified as '0' and if the pain scale decreased then the patient was classified as '1'.
Month 3, Month 6, Month 9 and Month 12
Mean Change From Baseline in 2nd Metacarpal Cortical Width at Month 12
時間枠：Month 12
Left posteroanterior (PA) hand/wrist X-ray were taken at Visit 1 and at the Month 12 visit to assess bone age and the between-treatment differences for change in 2nd metacarpal cortical width at Month 12 relative to baseline. If a fracture of the left upper extremity precluded radiographic imaging, then the right hand was evaluated for this purpose. In this case, the right hand was be imaged at both Visit 1 and at Month 12. The information was used in the assessment of bone density.
Month 12
Urinary Concentration of Zoledronic Acid at Month 12
時間枠：Month 12
Urine was collected overnight or for at least 4 waking hours from all patients able to provide specimens, to measure urinary concentration of zoledronic acid at Month 12. Only descriptive analysis done.
Month 12
Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids
時間枠：Baseline through Month 12
Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that zoledronic acid is safe for the treatment of osteoporotic children treated with glucocorticoids through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis done.
Baseline through Month 12

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

Novartis Pharmaceuticals

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

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12月4日

一次修了 (実際)

2018年3月5日

研究の完了 (実際)

2018年3月5日

試験登録日

最初に提出

2008年11月26日

QC基準を満たした最初の提出物

2008年11月26日

最初の投稿 (見積もり)

2008年11月27日

学習記録の更新

投稿された最後の更新 (実際)

2020年9月2日

QC基準を満たした最後の更新が送信されました

2020年9月1日

最終確認日

2020年9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

  • CZOL446H2337
  • 2008-001252-52 (EudraCT番号)

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?

未定

IPD プランの説明

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

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。

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