CancerNCT00126386
Zometa for the Management of Tumor-induced Hypercalcemia and Malignant Bone Pain in the Community
A study testing Zoledronic acid (Zometa) in people with Cancer and Hypercalcemia, run by Alberta Health services at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Hypercalcemia, Pain
- What is being tested?
- Zoledronic acid (Zometa)
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2004to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not on a regular bisphosphonate regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zoledronic Acid (Zometa) for the Management of Tumor-induced Hypercalcemia (TIH) and Malignant Bone Pain (MBP) in the Community: A Feasibility Study
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.
- Conditions
- Cancer, Hypercalcemia, Pain
- Being tested
- Zoledronic acid (Zometa)
- Keywords
- tumor induced hypercalcemia, malignant bone pain, bisphosphonates, cancer, palliative, Zometa, palliative patient, treatment in community
- Medical subject headings
- Neoplasms, Hypercalcemia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acid (Zometa)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of treating hypercalcemia in the community
resources required
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2005 (estimated)
- Study startJan 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
- Investigators
- Jose Pereira, MD, Principal investigator, Alberta Cancerboard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126386
- Sponsor's protocol ID
- 17280
- Other IDs
- 17280
- Status last verified
- Aug 2011
- First submitted
- 2 Aug 2005
- Last updated
- 21 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zoledronic Acid (Zometa) for the Management of Tumor-induced Hypercalcemia (TIH) and Malignant Bone Pain (MBP) in the Community: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00126386
- Acronym / sponsor ID
- 17280
- Conditions
- Cancer, Hypercalcemia, Pain
- Keywords
- tumor induced hypercalcemia, malignant bone pain, bisphosphonates, cancer, palliative, Zometa, palliative patient, treatment in community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 4 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not on a regular bisphosphonate regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoledronic acid (Zometa) | Drug | – |
Primary outcome
feasibility of treating hypercalcemia in the community
resources required
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Pereira, MD principal investigator
Alberta Cancerboard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoledronic acid (Zometa) in people with Cancer and Hypercalcemia, run by Alberta Health services at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of treating hypercalcemia in the community. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2011.