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

Not Applicable

Completed

• Conditions: Cancer; Hypercalcemia; Pain

• Registration Number: NCT00126386
• Lead Sponsor: Alberta Health services

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-08-02
• Study First Submitted QC: 2005-08-02
• Study First Posted: 2005-08-04
• Study Completion: 2006-09
• Status Verified: 2011-08
• Last Update Submitted: 2011-11-18
• Last Update Posted: 2011-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
feasibility of treating hypercalcemia in the community
resources required

Trial Locations

Locations (1)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada