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

Alberta Health services

Status: Completed

Conditions: Hypercalcemia; Cancer; Pain

Treatments: Drug: Zoledronic acid (Zometa)

Study type: Interventional

Funder types: Other

Identifiers

NCT00126386

17280

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)