ClinicalTrials.gg
CompletedNCT00126386Updated Nov 21, 2011

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

An interventional study of Zoledronic acid (Zometa) in Cancer, Hypercalcemia and Pain, sponsored by Alberta Health services. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-21.

Sponsored by Alberta Health services · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer
  • Hypercalcemia
  • Pain

Keywords

  • tumor induced hypercalcemia
  • malignant bone pain
  • bisphosphonates
  • cancer
  • palliative
  • Zometa
  • palliative patient
  • treatment in community
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's enrollment of 11 is below the median of 60 across 7,703 interventional studies indexed under Neoplasms.

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Lead sponsor

Alberta Health services is the lead sponsor of 40 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 bone disease

Exclusion criteria

Exclusion Criteria:

  • Not on a regular bisphosphonate regimen
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. feasibility of treating hypercalcemia in the community

  2. resources required

07

Study locations

1 site
  • Tom Baker Cancer Centre
    Calgary, Alberta T2N 4N2, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2004 and a completion of Sep 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2005
First posted
Aug 4, 2005
Start
Jan 2004
CompletionActual
Sep 2006
Last update
Nov 21, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00126386
Lead sponsor
Alberta Health services
First posted
Aug 4, 2005
Start date
Jan 2004
Completion
Sep 2006
Last update
Nov 21, 2011

Study contacts

Jose Pereira, MD
principal investigator · Alberta Cancerboard

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Zoledronic Acid

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