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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer, Hypercalcemia, Pain

Intervention / Treatment
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* Drug: Zoledronic acid (Zometa)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zoledronic acid (Zometa)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of treating hypercalcemia in the community |  |  | 
| resources required |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor induced hypercalcemia, malignant bone pain, bisphosphonates, cancer, palliative, Zometa, palliative patient, treatment in community