Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Plasma Cell Neoplasm | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observation
- description
- Patients will be observed and will undergo assessment of therapy complications.
- interventionNames
- Procedure: assessment of therapy complications
Primary outcomes (1)
- measure
- Diagnosis of confirmed osteonecrosis of the jaw (ONJ)
- timeFrame
- 3 years
Secondary outcomes (5)
- measure
- Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ
- timeFrame
- 3 years
- measure
- Clinical presentation and natural history of ONJ
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
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 dosesReferences
Publications (1)
- DERIVEDVan Poznak CH, Darke A, Moinpour CM, Bagramian RA, Schubert MM, Gralow JR, Wade JL 3rd, Unger JM. Dental health status and patient-reported outcomes at baseline in patients participating in the osteonecrosis of the jaw registry study, SWOG S0702. Support Care Cancer. 2017 Apr;25(4):1191-1199. doi: 10.1007/s00520-016-3509-3. Epub 2016 Dec 7. PMID 27928641