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

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ClinicalTrials.gov Identifier: NCT00126386
Recruitment Status : Completed
First Posted : August 4, 2005
Last Update Posted : November 21, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Cancer Hypercalcemia Pain Drug: Zoledronic acid (Zometa)

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2004
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. feasibility of treating hypercalcemia in the community
  2. resources required

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126386


Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Jose Pereira, MD Alberta Cancerboard
More Information

ClinicalTrials.gov Identifier: NCT00126386     History of Changes
Other Study ID Numbers: 17280
First Posted: August 4, 2005    Key Record Dates
Last Update Posted: November 21, 2011
Last Verified: August 2011

Keywords provided by AHS Cancer Control Alberta:
tumor induced hypercalcemia
malignant bone pain
bisphosphonates
cancer
palliative
Zometa
palliative patient
treatment in community

Additional relevant MeSH terms:
Hypercalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs