Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT01488851
Eligibility Criteria:
Inclusion Criteria:
1. Bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease.
2. All participants must be planning to receive zoledronic acid (as their sole bisphosphonate therapy) within 30 days after registration. Patients previously treated with bisphosphonate therapy are eligible if the following criteria apply:
1. Patients may have previously received at most 3 doses of intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration or
2. Patients may have received intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid to treat metastatic bone disease within 90 days prior to registration. Patients receiving any of these regimens for metastatic bone disease prior to 90 days before registration are not eligible, or c. Prior oral bisphosphonate therapy at any time prior to registration is allowed.
3. No pre-existing diagnosis of ONJ.
4. No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer.
5. Zubrod performance status of 0-3.
6. Willing and physically able to comply with the study procedures and assessments.
7. Can concurrently participate in other therapeutic and non-therapeutic clinical trials.
8. No other prior malignancy is allowed except for the following: adequately treated basal cell 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.
9. Must be informed of the investigational nature of this study and must sign and give written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01488851
Study Brief:
Protocol Section:
NCT01488851