{"id":29757,"date":"2020-05-27T06:27:15","date_gmt":"2020-05-27T04:27:15","guid":{"rendered":"https:\/\/www.abcsg.org\/?page_id=29757"},"modified":"2024-04-09T06:33:14","modified_gmt":"2024-04-09T04:33:14","slug":"abcsg-18-za-study-details","status":"publish","type":"page","link":"https:\/\/www.abcsg.org\/en\/abcsg-studies-archive\/abcsg-18-and-zoledronic-acid-substudy\/abcsg-18-za-study-details\/","title":{"rendered":"ABCSG 18 ZA Study details"},"content":{"rendered":"

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy\/ Zoledronic Acid (ZA) Substudy<\/p>\n

ABCSG 18 ZA was developed as an additional protocol to assess the effects of a single intravenous ZA administration on bone density, fracture incidence, and bone turnover markers (CTX and osteocalcin) in a subset of ABCSG 18 patients after discontinuation of denosumab.<\/p>\n

Treatment arms: <\/strong><\/h3>\n

single dose of Zoledronic Acid 5 mg IV (Therapy Arm)\/ management according to current Standard of Care (Control Arm)<\/p>\n

Exploratory objective:<\/strong><\/h3>\n

To evaluate the impact of a single intravenous (IV) ZA administration on bone mineral density (BMD), fracture incidence (clinical and morphometric), and bone turnover markers (C-terminal telopeptide [CTX] and Osteocalcin) in ZA substudy.<\/p>\n

Exploratory Endpoints<\/strong><\/h3>\n
    \n
  • Percent change in lumbar spine, total hip and femoral neck BMD from baseline to months 6, 12, and 18.<\/li>\n
  • Percent change in bone turnover marker values (CTX and Osteocalcin) from baseline to months 6, 12, and 18.<\/li>\n
  • Fracture incidence (clinical and morphometric) at baseline and then at months 6, 12, and 18 after day 1.<\/li>\n<\/ul>\n

    Inclusion Criteria for ZA Substudy<\/strong><\/h3>\n
      \n
    • Obtain signed and dated written informed consent prior to performing any study-specific procedure<\/li>\n
    • Subjects that received OLP denosumab and completed OLP treatment<\/li>\n
    • Last OLP denosumab administration no longer than 9 months ago<\/li>\n<\/ul>\n

      Exclusion Criteria for ZA Substudy<\/strong><\/h3>\n
        \n
      • Current or prior ZA administration<\/li>\n
      • Subjects who ended treatment with investigational product (IP) prematurely in the double-blind phase and OL phase<\/li>\n
      • Known sensitivity or intolerance to any of the products to be administered during the study (eg, ZA, calcium or vitamin D)<\/li>\n
      • Known history of any of the following conditions either by subject self report or chart review\n
          \n
        • Paget\u2019s disease (bone), Cushing\u2019s disease, hyperprolactinemia or other active metabolic bone disease<\/li>\n
        • Known history of hypocalcemia<\/li>\n
        • Major surgery, or significant traumatic injury occurring within 4 weeks prior to randomization<\/li>\n
        • Parathyroid glands in neck surgically removed<\/li>\n
        • Any sections of intestine removed<\/li>\n
        • Known human immunodeficiency virus infection<\/li>\n
        • Active infection with hepatitis B or hepatitis C virus<\/li>\n<\/ul>\n<\/li>\n
        • Known liver or renal disease as determined by the investigator and indicated by the following criteria:\n
            \n
          • Aspartate aminotransferase \u2265 2.5 x ULN<\/li>\n
          • Alanine transaminase \u2265 2.5 x ULN<\/li>\n
          • Serum creatinine \u2265 2 x ULN<\/li>\n
          • Creatine clearance < 35ml\/min<\/li>\n<\/ul>\n<\/li>\n
          • Subjects that are pregnant or breastfeeding\n
              \n
            • All subjects with reproductive potential must have a negative pregnancy test within 7 days before randomization<\/li>\n<\/ul>\n<\/li>\n
            • Subjects who are osteoporotic in baseline BMD<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"

              A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy\/ Zoledronic Acid (ZA) Substudy ABCSG 18 ZA was developed as an additional protocol to assess the effects of a single intravenous ZA administration on bone density, fracture incidence, and bone […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":35541,"menu_order":14,"comment_status":"closed","ping_status":"closed","template":"page-einzel-studie-intern.php","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"class_list":["post-29757","page","type-page","status-publish","hentry"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-12-12 19:37:49","action":"delete","newStatus":"draft","terms":[],"taxonomy":"translation_priority","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/29757","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/comments?post=29757"}],"version-history":[{"count":1,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/29757\/revisions"}],"predecessor-version":[{"id":29758,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/29757\/revisions\/29758"}],"up":[{"embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/pages\/35541"}],"wp:attachment":[{"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/media?parent=29757"}],"wp:term":[{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abcsg.org\/en\/wp-json\/wp\/v2\/tags?post=29757"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}