JP2005514400A - 骨疾患の治療方法 - Google Patents
骨疾患の治療方法 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A—HUMAN NECESSITIES
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- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
本発明の方法は、負荷量の骨活性ホスホネート及び維持量の骨活性ホスホネートの投与を含む。したがって、これらのプロセスにおいて使用される具体的な化合物及び組成物は、製薬上許容可能なものでなければならない。
本明細書で使用する時、「投与」は、適切な医療基準において、治療する対象者に本発明で使用される活性物質を骨の構築に効果的な形で送給する、あらゆる方法を意味する。活性物質は、既知の様々な投与方法のいずれかによって投与されてよく、それには例えば、経口的方法、皮膚・粘膜的方法(例えば、皮膚、舌下、鼻腔内、及び直腸方法)、非経口投与方法(例えば、皮下注射、筋肉注射、関節内注射、静脈注射)、局所的方法(経皮的方法)、及び吸入などがある。したがって具体的な投与方式には、経口投与、経皮投与、粘膜投与、舌下投与、筋肉内投与、静脈内投与、腹膜内(intrapertioneal)投与、皮下投与、及びその他の局所投与が挙げられるが、これらに限定されない。
本発明の方法は、
(a)負荷量のビスホスホネートを約7日間〜約180日間投与するステップと、
(b)ステップ(a)の後で、継続維持量のビスホスホネートを投与するステップと
を含む。
ここで、前記負荷量は、前記維持量の約2倍〜約20倍である。
骨活性ホスホネートは、製薬上許容可能な様々な組成物のいずれにおいても投与してよい。このような組成物は、活性物質と、製薬上許容可能なキャリアとを含んでよい。製薬上許容可能なキャリアには、ヒト又は下等動物への投与に適した、固体又は液体フィラー希釈液、又はカプセル化物質、及びこれらの混合物が挙げられる。本明細書で使用する時、用語「適合性のある」は、医薬組成物の構成成分が、通常の使用状況下で医薬組成物の薬効を大幅に減少させる相互作用がないような形で、活性物質と混ざり合うこと、及び互いに混ざり合うことができることを意味する。言うまでもなく、製薬上許容可能なキャリアは、治療される対象者への投与に適したものになるように、十分に高純度で、十分に低毒性でなければならない。
本発明はまた、本発明の方法を好都合に及び効果的に実施するキットも提供する。このようなキットは、負荷期間のための1つ以上の骨活性ホスホネートの単位投与量と、維持期間のための1つ以上の骨活性ホスホネートの単位投与量と、本発明の方法の服用遵守を促進する手段とを含む。このようなキットは、治療すべき対象者が適切な活性物質を的確な用量及び的確な方式で摂取するのを保証する、好都合で効果的な手段を提供する。このようなキットの服用遵守手段には、本発明の方法による活性物質の投与を促進するあらゆる手段が含まれる。このような服用遵守手段には、取扱説明書、包装、及び分配手段、並びにこれらの組み合わせが挙げられる。包装及び分配手段の例は、米国特許第4,761,406号(フローラ(Flora)ら、1988年8月2日発行)及び米国特許第4,812,311号(ウチトマン(Uchtman)、1989年3月14日発行)に記載のものを含め、当該技術分野において周知であり、これらすべての特許を参考のために本明細書に示す。
閉経後骨粗鬆症と診断された体重約60kgの女性患者を、本発明の方法によって治療する。具体的には、1日当たり30mgのリセドロネートを30日間にわたって患者に経口的に与える。その後すぐに、1週間当たり35mgのリセドロネートを2年間にわたって患者に経口的に与える。2年後に腸骨稜の骨の生検を採取すると、その患者のベースライン生検に比べて再構築単位の平均壁圧の増加が示される。
前立腺癌及び高骨代謝回転と診断された体重約70kgの男性を、本発明の方法によって治療する。具体的には、患者は1日当たり35mgのアレンドロネートを14日間にわたって毎日摂取する。この期間後に、患者は1週間当たり70mgの維持量のアレンドロネートを1年間経口摂取する。
体重約58kgの女性を、糖質コルチコイド誘発型骨粗鬆症と診断する。その後、対象者を本発明の方法によって治療する。具体的には、1日当たり30mgのリセドロネートを30日間にわたって対象者に経口的に与える。その時点で、投薬を維持投薬に切り替えて、35mgを隔週で3年間にわたって経口的に投与する。
体重約67kgの男性患者に、静脈注射により、合計9mgのリセドロネートを週1回の2度の投薬に均等に分けて(1週間当たり4.5mgを1日目と8日目に)与える。29日目(最初の負荷投薬後)に3mgの維持量を与え、その後29日目から隔月で3mgを与える。
Claims (10)
- 負荷期間のためのビスホスホネートの単位投与量と、負荷期間に続く維持期間のためのビスホスホネートの単位投与量とを含む処方計画に従う骨量増加治療において使用するためのキット。
- 前記キットが、服用遵守を促進する手段をさらに含むことを特徴とする請求項1に記載のキット。
- 前記負荷投薬期間が、約7〜180日間であるであることを特徴とする請求項1又は2に記載のキット。
- 前記ビスホスホネートが、リセドロネート、アレンドロネート酸、パミドロネート、チルドロネート、クロドロネート、シマドロネート、イバンドロネート、ゾレンドロネート、並びにこれらの塩及びエステル類からなる群から選択されることを特徴とする請求項1〜3のいずれか一項に記載のキット。
- 前記ビスホスホネートが、リセドロネート又はアレンドロン酸であることを特徴とする請求項19に記載のキット。
- 負荷時のビスホスホネートの単位投与量が、維持期間のビスホスホネートの単位投与量の2〜20倍であることを特徴とする請求項1〜5のいずれか一項に記載のキット。
- 医薬品キットの製造のためのビスホスホネートの使用であって、該キットが、
a.負荷量のビスホスホネートを約7日間〜約180日間投与するステップと、
b.ステップ(a)の後で、継続維持量のビスホスホネートを投与するステップであり、前記負荷量が、前記維持量の約2倍〜約20倍であるステップと
を含むステップに従う骨量増加治療の促進に使用されることを特徴とするビスホスホネートの使用。 - 前記ビスホスホネートが、
リセドロネート、アレンドロン酸、パミドロネート、チルドロネート、クロドロネート、シマドロネート、イバンドロネート、ゾレンドロネート、並びにこれらの塩及びエステル類を含む群から選択されることを特徴とする請求項7に記載の使用。 - 薬剤の製造のためのビスホスホネートの使用であって、該薬剤が、
a.負荷量のビスホスホネートを約7日間〜約180日間投与するステップと、
b.ステップ(a)の後で、継続維持量のビスホスホネートを投与するステップであり、前記負荷量が、前記維持量の約2倍〜約20倍であるステップと
に従う骨量増加治療のためのものであることを特徴とするビスホスホネートの使用。 - 前記負荷量の濃度が、維持量の2〜20倍であることを特徴とする請求項9に記載の使用。
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US34487501P | 2001-12-21 | 2001-12-21 | |
PCT/US2002/040234 WO2003055496A1 (en) | 2001-12-21 | 2002-12-16 | Method for the treatment of bone disorders |
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JP2009526013A (ja) * | 2006-02-16 | 2009-07-16 | エフ.ホフマン−ラ ロシュ アーゲー | イバンドロネートの新規投与計画 |
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- 2002-12-16 EP EP20020795891 patent/EP1455796A1/en not_active Ceased
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Publication number | Priority date | Publication date | Assignee | Title |
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JP2009526013A (ja) * | 2006-02-16 | 2009-07-16 | エフ.ホフマン−ラ ロシュ アーゲー | イバンドロネートの新規投与計画 |
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