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 ASMTS

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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 for mets bone disease w/i 30 days after regist.  (NOTE:  Osteoclast inhibition therapies will continue thereafter as clinically indicated.)  Pts previously treated w/osteoclast inhibition therapies are eligible if:

  a)  Prior osteoclast inhibition for low bone mass (osteoporosis or osteopenia):

  • May have received <3 doses of osteoclast inhibition therapy w/denosumab, IV ibandronate, pamidronate, or zoledronic acid for low bone mass (osteopenia or osteoporosis) w/i 3 yrs pre-regist.

  • Prior oral bisphonate therapy at osteoporosis or osteopenia dosing at any time pre-regist is allowed.  Prior exposures to other meds used to treat low bone mass at osteoporosis or osteopenia dosing are allowed.

  b)  Prior osteoclast inhibition for mets bone disease (tumor involing bone):

  • May have received osteoclast inhibition therapy w/denosumab, ibandronate (PO or IV cancer dosing), pamidronate, or zoledronic acid to treat mets bone disease w/i 180 days pre-regist.

  c)  No prior osteoclast inhibiting therapy at higher dosing than outlined above at any time pre-regist.

  NOTE:  See protocol for prior dosing maximums.

• 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).

• 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.  If candidate has had multiple tumors of same basic origin, this may be counted as 1 malignancy (i.e., breast cancer [bilat disease of multiple lesions], head & neck cancer [tongue & laryngeal]).

• PRESTUDY REQUIREMENTS:

  • H&P

  • Dental Exam (recommended)

  • CBC/diff/platelets*

  • Ca, albumin*

  • Serum creat*

  • CrCl (calc)*

  • Pregnancy test*

  • Phosphate, Mg, lytes*

  • Dental imaging (recommended)

  • 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.