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Completed

NCT Number: NCT00089661

AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

The purpose of this trial is to evaluate AMG 162 in the treatment of bone loss in subjects undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer.

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Key information

Conditions

Breast Cancer Bone Diseases Bone Diseases, Metabolic Breast Diseases Breast Neoplasms Low Bone Mineral Density Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Osteopenia Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Histologically or cytologically confirmed adenocarcinoma of the breast
  • Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase inhibitor therapy, and are expected to stay on aromatase inhibitor therapy for the duration of the 24-month study
  • All treatment pathway must be completed ≥ 4 weeks prior to study entry, and all acute toxic effect of any above therapy must be resolved to ≤ Grade 1 by National Cancer Institution (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
  • Female > 18 years of age
  • ECOG Performance status 0 and 1
  • Lumbar spine, total hip or femoral neck BMD equivalent to a t-score classification of -1.0 to -2.5
  • Subject is willing and able to provide signed consent before any study-specific procedure

Other criteria also apply.

Treatment and study plan

Placebo

Drug

60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

AMG 162 / Denosumab

Drug

60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months

Primary outcomes

  1. Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12

    Time frame: 12 months

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Secondary outcomes

  1. Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6

    Time frame: 6 months

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

  2. Total Hip Bone Mineral Density Percent Change From Baseline at Month 12

    Time frame: 12 months

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

  3. Total Hip Bone Mineral Density Percent Change From Baseline at Month 6

    Time frame: 6 months

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

  4. Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12

    Time frame: 12 months

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

  5. Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6

    Time frame: 6 months

    Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Aromatase Inhibitor Therapy for Non-metastatic Breast Cancer

Important dates

Study start
2004
Primary completion
2007
Study completion
2009
First posted
Aug 11, 2004
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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