Completed

ONJ Natural History in Cancer Patients Registry

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: October 2012
See protocol details

Summary

Principal SponsorAmgen
Last updated: December 21, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

The purpose of the ONJ case registry is to describe the natural history of positively-adjudicated ONJ in subjects with cancer with an observation period of 5 years. Most of these subjects are expected to have received bone antiresorptive agents such as bisphosphonates or denosumab together with cancer-specific therapies (eg, chemotherapy, steroids, or anti-angiogenics). It is also possible that the registry will include subjects with cancer who developed ONJ without exposure to any antiresorptive therapy.

NCT01666106
Principal SponsorAmgen
Last updated: December 21, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

327 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate
Adult ( >= 18 years of age) with diagnosis of cancer
ECOG <= 2 and expected survival >= 3 months
Newly diagnosed, positively-adjudicated ONJ
Subject or subject's legally acceptable representative has provided written informed consent
Show More Criteria
3 exclusion criteria prevent from participating
History of radiation to the jaws administered for the treatment of cancer
Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 64 locations

Research Site

Beverly Hills, United StatesOpen Research Site in Google Maps

Research Site

Duarte, United States

Research Site

Denver, United States

Research Site

Farmington, United States
Completed64 Study Centers