CancerNCT01488851
Study to Assess Incidence of ONJ in Pts With Bone Mets Starting Zoledronic Acid Treatment
An observational study of Cancer, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw in cancer patient with bone metastasis starting Zoledronic acid treatment Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2012to Jan 2015
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bone Metastases
Who may be able to join
- Bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease.
- All participants must be planning to receive zoledronic acid (as their sole bisphosphonate therapy) within 30 days after registration. Patients previously treated with bisphosphonate therapy are eligible if the following criteria apply:
- Patients may have previously received at most 3 doses of intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration or
- Patients may have received intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid to treat metastatic bone disease within 90 days prior to registration. Patients receiving any of these regimens for metastatic bone disease prior to 90 days before registration are not eligible, or c. Prior oral bisphosphonate therapy at any time prior to registration is allowed.
- No pre-existing diagnosis of ONJ.
- No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer.
Show all 11Show fewer
- Zubrod performance status of 0-3.
- Willing and physically able to comply with the study procedures and assessments.
- Can concurrently participate in other therapeutic and non-therapeutic clinical trials.
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
- Must be informed of the investigational nature of this study and must sign and give written informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital& Research Center
Riyadh, 11211
About this study
Official title: Prospective Observational Multi Central Cohort Study to Assess the Incidence of Osteo Necrosis of Jaw in Patients With Bone Metastasis Starting Zoledronic Acid Treatment
Prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw in cancer patient with bone metastasis starting Zoledronic acid treatment
Read the detailed description
Prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw (ONJ) in pts with bone metastasis starting Zoledronic acid treatment
- Conditions
- Cancer
- Keywords
- Osteo necrosis of the Jaw
- Medical subject headings
- Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2014
- Study completionJan 2015
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Walid Rasheed, MD, Principal investigator, Oncology Centre, KFSH&RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488851
- Sponsor's protocol ID
- 2111-094
- Status last verified
- Jan 2016
- First submitted
- 7 Dec 2011
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Multi Central Cohort Study to Assess the Incidence of Osteo Necrosis of Jaw in Patients With Bone Metastasis Starting Zoledronic Acid Treatment
- ClinicalTrials.gov ID
- NCT01488851
- Acronym / sponsor ID
- 2111-094
- Conditions
- Cancer
- Keywords
- Osteo necrosis of the Jaw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Dec 2011 (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.
Prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw in cancer patient with bone metastasis starting Zoledronic acid treatment
Detailed description
Prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw (ONJ) in pts with bone metastasis starting Zoledronic acid treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bone Metastases
Key inclusion criteria (11 listed)
- Bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease.
- All participants must be planning to receive zoledronic acid (as their sole bisphosphonate therapy) within 30 days after registration. Patients previously treated with bisphosphonate therapy are eligible if the following criteria apply:
- No pre-existing diagnosis of ONJ.
- No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer.
- Zubrod performance status of 0-3.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 1 Mar 2019.
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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.
Walid Rasheed, MD principal investigator
Oncology Centre, KFSH&RC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 11 inclusion and 0 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 1 Mar 2019. 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 Saudi Arabia. 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.
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 1 Mar 2019.