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Completed

NCT Number: NCT00126386

Zometa for the Management of Tumor-induced Hypercalcemia and Malignant Bone Pain in the Community

Treatment in the home and hospice of long-term care facilities, particularly for non-ambulatory patients, could provide significant advantages for patients and for the region. The Calgary Health Region has a unique resource in the home parenteral therapy program (HPTP). With the assistance of HPTP, patients requiring bisphosphonate treatment for the management of tumor-induced hypercalcemia (TIH) or malignant bone pain (MBP) could be treated in the community (ie at home). However, the resources required and the costs associated with community-based (homes, hospices, long-term care facilities) treatment of TIH and MBP need to be identified and evaluated so as to guide future regional decision making.

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Key information

Conditions

Cancer Calcium Metabolism Disorders Hypercalcemia Metabolic Diseases Neoplasms Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

About this study

Treatment in the home and hospice of long-term care facilities, particularly for non-ambulatory patients, could provide significant advantages for patients and for the region. The Calgary Health Region has a unique resource in the home parenteral therapy program (HPTP). With the assistance of HPTP, patients requiring bisphosphonate treatment for the management of TIH or MBP could be treated in the community (ie at home). However, the resources required and the costs associated with community-based (homes, hospices, long-term care facilities) treatment of TIH and MBP need to be identified and evaluated so as to guide future regional decision making.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

If hypercalcemic:

  • Serum corrected Ca+++>= 2.5 mmol/L and symptomatic hypercalcemia
  • Asymptomatic hypercalcemia with corrected Ca+++>= 3.0 mmol/L
  • Moderate to severe intolerable pain (>=6/10 on numerical rating scale [NRS]) despite optimal treatments with a strong opioid such as morphine, hydromorphone, fentanyl, oxycodone or methadone
  • Radiotherapy bone pain related to metastatic bone disease

Exclusion criteria

  • Not on a regular bisphosphonate regimen

Treatment and study plan

Zoledronic acid (Zometa)

Drug

Primary outcomes

  1. feasibility of treating hypercalcemia in the community

  2. resources required

Sponsors and collaborators

Lead sponsor

Alberta Health services

Other

Registry information

Official study title

Zoledronic Acid (Zometa) for the Management of Tumor-induced Hypercalcemia (TIH) and Malignant Bone Pain (MBP) in the Community: A Feasibility Study

Important dates

Study start
2004
Study completion
2006
First posted
Aug 4, 2005
Registry last updated
Nov 21, 2011

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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