Zometa for the Management of Tumor-induced Hypercalcemia and Malignant Bone Pain in the Community
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Purpose
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 | Intervention |
|---|---|
|
Cancer Hypercalcemia Pain |
Drug: Zoledronic acid (Zometa) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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 |
- feasibility of treating hypercalcemia in the community
- resources required
| Enrollment: | 11 |
| Study Start Date: | January 2004 |
| Study Completion Date: | September 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00126386 History of Changes |
| Other Study ID Numbers: | 17280, 17280 |
| Study First Received: | August 2, 2005 |
| Last Updated: | November 18, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Alberta Health Services:
|
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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013