NCT00874211|CompletedDMC

S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases

S0702: A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients With Bone Metastases Starting Zoledronic Acid Treatment

SWOG Cancer Research Network ClinicalTrials.gov

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2 other identifiers

S0702U10CA037429

Study Type

observational

Target

3,571

Locations

3 countries

Sites

453

Timeline

RegisteredApr 2009

StartedDec 2008

CompletionJun 2019

Brief Summary

RATIONALE: Gathering information about how often osteonecrosis of the jaw occurs in patients receiving zoledronic acid for bone metastases may help doctors learn more about the disease and provide the best follow-up care. PURPOSE: This clinical trial is studying osteonecrosis of the jaw in patients with cancer who are receiving zoledronic acid for bone metastases.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,571

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Dec 2008

Longer than P75 for all trials

Geographic Reach

3 countries

453 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.5 years study duration

Study Start

First participant enrolled

December 1, 2008

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed

10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed

Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

10.5 years

First QC Date

April 1, 2009

Last Update Submit

July 3, 2019

Conditions

Breast Cancer Lung Cancer Metastatic Cancer Multiple Myeloma Plasma Cell Neoplasm Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific

Keywords

bone metastasesunspecified adult solid tumor, protocol specificrefractory multiple myelomastage I multiple myelomastage II multiple myelomastage III multiple myelomamale breast cancerrecurrent breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent prostate cancerstage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent non-small cell lung cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerextensive stage small cell lung cancerlimited stage small cell lung cancerrecurrent small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Diagnosis of confirmed osteonecrosis of the jaw (ONJ)
3 years

Secondary Outcomes (5)

Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ
3 years
Clinical presentation and natural history of ONJ
3 years
Overall and disease-specific cumulative incidence
3 years
Association of baseline factors with cumulative incidence of confirmed ONJ
3 years
Association between patient-related outcomes and confirmed incidence
3 years

Study Arms (1)

Observation

Patients will be observed and will undergo assessment of therapy complications.

Procedure: assessment of therapy complications

Interventions

assessment of therapy complicationsPROCEDURE

By dental and medical assessments.

Observation

Eligibility Criteria

AgeUp to 120 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

SWOG membership and CCOP participants through CTSU.

DISEASE CHARACTERISTICS: * Participant must have bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease * Treatment with osteoclast inhibition is clinically indicated * Must be planning to receive zoledronic acid\* within the next 30 days NOTE: \*Osteoclast inhibition therapy will continue thereafter as clinically indicated. * No prior diagnosis of osteonecrosis of the jaw * Patients previously treated with osteoclast inhibition therapy are eligible, provided the following criteria apply: * Prior osteoclast inhibition for low bone mass (osteoporosis or osteopenia): * Patients may have previously received at most 3 doses of osteoclast-inhibiting therapy with denosumab, IV ibandronate, pamidronate, or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration * Prior oral bisphosphonate therapy at osteoporosis or osteopenia dosing at any time prior to registration is allowed * Prior exposures to other medications used to treat low bone mass at osteoporosis or osteopenia dosing are permitted * Prior osteoclast inhibition for metastatic bone disease (tumor involving bone): * Patients may have previously received osteoclast-inhibiting therapy with denosumab, ibandronate (oral or IV cancer dosing), pamidronate, or zoledronic acid to treat metastatic bone disease within 180 days prior to registration * Patients receiving these regimens for metastatic bone disease prior to 180 days before registration are not eligible * Prior osteoclast-inhibiting therapy at higher dosing than outlined above at any time prior to registration is not allowed PATIENT CHARACTERISTICS: * Zubrod performance status 0-3 * Patients who may be acutely ill from spinal cord compromise, hypercalcemia of malignancy, or other process may be study candidates once the acute condition has been addressed and performance status improves to 0-3 * Not pregnant or nursing * Negative pregnancy test * Willing and physically able to comply with study procedures and assessments * Willing to provide information on personal history, including tobacco and alcohol use, and pain assessment * Willing to provide access to prior and future dental information * No other prior malignancy except for any of the following: * Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin * In situ cervical cancer * Adequately treated stage I or II cancer for which the patient is currently in complete remission * Any other cancer for which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer * Concurrent participation in other therapeutic and non-therapeutic clinical trials allowed * The sum of prior IV bisphosphonate doses must not be greater than 10 * The sum of prior denosumab doses must not be greater than 8 * The total of both IV bisphosphonate and denosumab used for any indication must not be greater than 12 doses

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator
Novartiscollaborator

Study Sites (453)

Regional Medical Center

Anniston, Alabama, 36207, United States

Location

Providence Cancer Center at Providence Hospital

Mobile, Alabama, 36608, United States

Location

Providence Cancer Center

Anchorage, Alaska, 99508, United States

Location

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701, United States

Location

NEA Medical Clinic - East Matthews

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, 94524-4110, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

North Bay Cancer Center

Fairfield, California, 94533, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital

Grass Valley, California, 95945, United States

Location

Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, 95901, United States

Location

Mercy Cancer Center at Mercy Medical Center

Merced, California, 95340, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus