NCT00126386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

November 21, 2011

Status Verified

August 1, 2011

First QC Date

August 2, 2005

Last Update Submit

November 18, 2011

Conditions

CancerHypercalcemiaPain

Keywords

tumor induced hypercalcemiamalignant bone painbisphosphonatescancerpalliativeZometapalliative patienttreatment in community

Outcome Measures

Primary Outcomes (2)

  • feasibility of treating hypercalcemia in the community

  • resources required

Interventions

Zoledronic acid (Zometa)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not on a regular bisphosphonate regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

MeSH Terms

Conditions

NeoplasmsHypercalcemiaPain

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Calcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte ImbalanceNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jose Pereira, MD

    Alberta Cancerboard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 4, 2005

Study Start

January 1, 2004

Study Completion

September 1, 2006

Last Updated

November 21, 2011

Record last verified: 2011-08

Locations

CA(1)