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

NCT ID: NCT00126386

Last Updated: 2011-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-09-30

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.

Conditions

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Cancer Hypercalcemia Pain

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zoledronic acid (Zometa)

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alberta Health services

OTHER

Sponsor Role lead

Principal Investigators

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Jose Pereira, MD

Role: PRINCIPAL_INVESTIGATOR

Alberta Cancerboard

Locations

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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17280

Identifier Type: -

Identifier Source: secondary_id

17280

Identifier Type: -

Identifier Source: org_study_id