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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00126386
• Other study ID #: 17280
• Secondary ID: 17280
• Status: Completed
• Phase: N/A
• First received: August 2, 2005
• Last updated: November 18, 2011
• Start date: January 2004
• Est. completion date: September 2006

Study information

• Verified date: August 2011
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Hypercalcemia
• Pain

Intervention

Drug:
• Zoledronic acid (Zometa)

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility of treating hypercalcemia in the community
Primary	resources required