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About the project


Radiograph shows osteolytic metastasis in the distal femur of a 51-year-old woman with breast carcinoma. (Source: eMedicine.com)

more on breast cancer...



3D model of zoledronate, one of many bisphosphonates. (Source: Wikipedia)

Introduction

Women with advanced breast cancer commonly develop bone metastases, which present a major health problem and significantly decrease the patient's quality of life. Bone metastases cause pain, fractures, hypercalcaemia (too much calcium in the blood) and other complications, often described as skeletal related events.*

Under normal circumstances, osteoclasts (bone-resorbing cells) work in concert with the osteoblasts (bone-forming cells) to control the normal turnover of bone. After invasion of the bone, the cancer cells activate osteoclasts, which begin to resorb the bone uncontrollably, resulting in the formation of bone lesions (i.e., the resorbed bone is not replaced by a new bone tissue). This weakens the bone, causes pain and may result into fracture. A number of clinical trials have confirmed that bisphosphonates reduce the osteoclasts' activity, thus decreasing the risk of bone fracture, decrease calcium level in the blood and the risk of kidney stones (renal calculi) formation. Moreover, bisphosphonates have a significant analgesic effect (i.e., they reduce the pain).

* The following situations are described as "skeletal related events" within this project:

  • pathologic facture,
  • vertebral compression fracture,
  • radiotherapy for bone metastasis,
  • surgical therapy for bone metastasis,
  • tumour-induced hypercalcaemia.

Project objectives

The primary objective of the project is the assessment of skeletal related events in patients with a metastatic breast carcinoma treated in the Czech Republic and in Slovakia.

The secondary objectives of the study include:

  • analysis of treatment practice in skeletal related events,
  • analysis of bisphosphonate usage practice in the prevention of skeletal related events in metastases affecting the skeleton in a common clinical practice,
  • analysis of patient compliance in bisphosphonate treatment,
  • analysis of time interval between the occurrence of a bone metastasis and the incidence of a skeletal related event,
  • analysis of patients' survival related to skeletal related events.

Feel free to download the ICARUS Project Protocol (PDF, 168 kB).

The ICARUS registry is being solved within the CEBO project which aims to increase the quality and quantity of oncological clinical trials initiated by doctors and medical societies from the Czech Republic and Slovakia.

Literature

  1. Lipton A. 2007. Efficacy and safety of intravenous bisphosphonates in patients with bone metastases caused by metastatic breast cancer. Clin Breast Cancer 7(Suppl 1):S14-20.
  2. Mortimer JE, Schulman K, Kohles JD. 2007. Patterns of bisphosphonate use in the United States in the treatment of metastatic bone disease. Clin Breast Cancer 7(9):682-689.
  3. Ross JR, Saunders Y, Edmonds PM, Patel S, Wonderling D, Normand C, Broadley K. 2004. A systematic review of the role of bisphosphonates in metastatic disease. Health Technol Assess 8(4):1-176.
  4. Senaratne SG, Colston KW. 2002. Direct effects of bisphosphonates on breast cancer cells. Breast Cancer Res 4(1):18-23.