Study to Assess Incidence of ONJ in Pts With Bone Mets Starting Zoledronic Acid Treatment
This study is not yet open for participant recruitment.
Verified January 2012 by King Faisal Specialist Hospital & Research Center
Sponsor:
King Faisal Specialist Hospital & Research Center
Information provided by (Responsible Party):
King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier:
NCT01488851
First received: December 7, 2011
Last updated: January 23, 2012
Last verified: January 2012
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Purpose
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
| Condition |
|---|
|
Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Zoledronic acid
U.S. FDA Resources
Further study details as provided by King Faisal Specialist Hospital & Research Center:
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Bone Metastases
Criteria
Inclusion Criteria:
- 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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488851
Locations
| Saudi Arabia | |
| King Faisal Specialist Hospital& Research Center | |
| Riyadh, Saudi Arabia, 11211 | |
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
| Principal Investigator: | Walid Rasheed, MD | Oncology Centre, KFSH&RC |
More Information
No publications provided
| Responsible Party: | King Faisal Specialist Hospital & Research Center |
| ClinicalTrials.gov Identifier: | NCT01488851 History of Changes |
| Other Study ID Numbers: | 2111-094 |
| Study First Received: | December 7, 2011 |
| Last Updated: | January 23, 2012 |
| Health Authority: | Saudi Arabia: Ethics Committee |
Keywords provided by King Faisal Specialist Hospital & Research Center:
|
Osteo necrosis of the Jaw |
Additional relevant MeSH terms:
|
Zoledronic acid Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013