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

Primary Purpose

Cancer, Hypercalcemia, Pain

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Zoledronic acid (Zometa)

About this trial

This is an interventional treatment trial for Cancer focused on measuring tumor induced hypercalcemia, malignant bone pain, bisphosphonates, cancer, palliative, Zometa, palliative patient, treatment in community

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tom Baker Cancer Centre

Outcomes

Primary Outcome Measures

feasibility of treating hypercalcemia in the community

resources required

Secondary Outcome Measures

Full Information

NCT ID

NCT00126386

First Posted

August 2, 2005

Last Updated

November 18, 2011

Sponsor

Alberta Health services

1. Study Identification

Unique Protocol Identification Number

NCT00126386

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Alberta Health services

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Hypercalcemia, Pain

Keywords

tumor induced hypercalcemia, malignant bone pain, bisphosphonates, cancer, palliative, Zometa, palliative patient, treatment in community

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Zoledronic acid (Zometa)

Primary Outcome Measure Information:

Title

feasibility of treating hypercalcemia in the community

Title

resources required

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Pereira, MD

Organizational Affiliation

Alberta Cancerboard

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tom Baker Cancer Centre

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

12. IPD Sharing Statement

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

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