SWOG 0702 (NCT00874211) Observation in Patients with Bone Metastasis Receiving Zometa Clinical Trial

An Observational Study to Assess The Incidence of Rare Osteonecrosis (bone disease) of the Jaw (ONJ) in Cancer Patients with Bone Metastases (spread) starting Zoledronic Acid (Zometa) Treatment

Summary

The purpose of this study is to assess the occurrence of osteonecrosis of the jaw (ONJ) for 3 years in cancer patients with bone metastasis receiving zoledronic acid treatment.

Basic Eligibility Criteria:

• Must have bone metastasis from multiple myeloma, solid tumors or other malignancy
• Must receive zoledronic acid as the sole bisphosphonate (drugs that prevent bone loss) within 30 days after registration
• Patients previously treated with a bisphosphonate are eligible if:

1. They received at most 3 doses of intravenous (through vein) bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years
2. They received intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid to treat metastatic bone disease within 90 days
3. They received oral bisphosphonate therapy at any time

• Must not have a pre-existing diagnosis of ONJ
• Must not have a history of radiation to the maxillofacial (upper jaw/face) area for cancer
• Must have a performance status of 0-3 (a score from 1-5 determines a cancer patient’s general well-being/activity level)
• Must be willing to provide information on history, including tobacco and alcohol use, symptoms and pain
• A baseline dental exam must occur within 6 months. Dental imaging within 12 months is acceptable
• No other prior malignancy is allowed except: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or any other cancer from which the patient has been disease-free for 5 years