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

This study has been completed.
Sponsor:
Information provided by:
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00126386
First received: August 2, 2005
Last updated: November 18, 2011
Last verified: August 2011
History of Changes

August 2, 2005
November 18, 2011
January 2004
Not Provided
  • feasibility of treating hypercalcemia in the community
  • resources required
  • feasilibity of treating hypercalcemia in the community
  • resources required
Complete list of historical versions of study NCT00126386 on ClinicalTrials.gov Archive Site
Not Provided
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Zometa for the Management of Tumor-induced Hypercalcemia and Malignant Bone Pain in the Community
Zoledronic Acid (Zometa) for the Management of Tumor-induced Hypercalcemia (TIH) and Malignant Bone Pain (MBP) in the Community: A Feasibility 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 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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cancer
  • Hypercalcemia
  • Pain
Drug: Zoledronic acid (Zometa)
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
September 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00126386
17280, 17280
Yes
Not Provided
Alberta Health Services
Not Provided
Principal Investigator: Jose Pereira, MD Alberta Cancerboard
Alberta Health Services
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP