SWOG 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"

NOTE:  Requires electronic submission of serial CT or MRI via AG Mednet.  KCCOP will submit the images to AG Mednet if they are supplied on CD to KCCOP by the treating facility.

Treatment Plan    (Supplied Drug:  None)

BASELINE

Dentist Contact Form

Dental Asmt Form

Baseline Exam

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REGISTRATION

Prestudy Form

Baseline Blood Submission (optional - serum & WBC for DNA)

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NON-PROTOCOL:  Cancer & Dental Care as clinically indicated

PROTOCOL: 

Medical & Dental forms submitted q 6 mos

Serum submitted q 6 mos (optional)

Follow-up q 6 mos

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PTS DIAGNOSED w/ONJ WHILE ON STUDY

Switch to Follow-up q 3 mos

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OFF STUDY 3 YRS AFTER REGISTRATION

Eligibility

• Bone mets from multiple myeloma, solid tumors, or other malignancy for which IV bisphosphonate has clinical indications for tx of mets bone disease.

• Must plan to receive zoledronic acid (as sole bisphosphonate therapy) w/i 30 days after regist.  (NOTE:  Bisphosphonate will continue thereafter as clinically indicated.)  Pts previously treated w/bisphosphonates are eligible if:

  • Received <3 prior doses of IV bisphosphonate therapy w/ibandronate, pamidronate, or zoledronic acid for low bone mass (osteopenia or osteoporosis) w/i 3 yrs pre-regist OR

  • Received IV bisphosphonate therapy w/ibandronate, pamidronate, or zoledronic acid to treat mets bone dz w/i 90 days pre-regist (none of these regimens for mets bone dz is allowed prior to 90 days pre-regist) OR

  • Received prior PO bisphosphonate therapy at any time pre-regist

• No pre-existing ONJ.

• No hx of RT to maxillofacial area administered for therapeutic intent in tx of cancer.

• Zubrod 0-3.  NOTE:  Pts acutely ill from spinal cord compromise, hypercalcemia of malignancy or other process may be eligible once the acute condition has been addressed and Zubrod improves to 0-3.

• Willing and physically able to comply w/study procedures and asmts.

• Must be offered participation in blood submission for banking & DNA analysis.

• Willing to provide information on hx (including tobacco & alcohol use, symptoms, & pain asmt).

• Baseline dental exam w/i 6 mos pre-regist to include dental hx, dental exam, peridontal exam, & dental imaging.  Panoramic xray is preferred; intraoral films, bite wings, xray films, &/or digital files may be appropriate for some pts.  Dental imaging w/i 12 mos pre-regist is acceptable.  Dental Contact Form & Dental Asmt Form must be completed by dental health professional and returned pre-regist.

• Willing to provide access to prior & future dental information.

• Concurrent participation in other therapeutic & non-therapeutic clinical trials is allowed.

• No other prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, adequately treated Stg I or II cancer currently in CR, or any other cancer disease-free >5 yrs.

• PRESTUDY REQUIREMENTS:

  • H&P

  • Required Dental Exam

  • CBC/diff/platelets*

  • Ca, albumin*

  • Serum creat*

  • CrCl (calc)*

  • Pregnancy test*

  • Phosphate, Mg, lytes*

  • Dental imaging

  • Serum for banking (optional - contact KCCOP for kit)

  • Whole blood for DNA/banking (optional - contact KCCOP for kit)

  • Pt-Related Outcomes Asmt (included on Prestudy Form & Medical Asmt Form)

  • Prestudy Form (includes risk factors & pt hx)

  • Dentist Contact Form

  • Dental Asmt Form

  *      Suggested for good medical practice

• Signed informed consent.