Study to Assess Incidence of ONJ in Pts With Bone Mets Starting Zoledronic Acid Treatment

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

Study Overview

• Status: Completed
• Conditions: Cancer

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital& Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Bone Metastases

Description

Inclusion Criteria:

1. Bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease.

2. 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:

   1. 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
   2. 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.
3. No pre-existing diagnosis of ONJ.
4. No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer.
5. Zubrod performance status of 0-3.
6. Willing and physically able to comply with the study procedures and assessments.
7. Can concurrently participate in other therapeutic and non-therapeutic clinical trials.
8. 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.
9. Must be informed of the investigational nature of this study and must sign and give written informed consent.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center
• Investigators: Principal Investigator: Walid Rasheed, MD, Oncology Centre, KFSH&RC

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: December 7, 2011
• First Submitted That Met QC Criteria: December 7, 2011
• First Posted (ESTIMATE): December 8, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Osteo necrosis of the Jaw
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: 2111-094