Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Mouth and Tooth Diseases

Neoplasm Metastasis

Osteonecrosis

Bone Diseases

Bisphosphonate-Associated Osteonecrosis of the Jaw

Neoplastic Processes

Necrosis

Jaw Diseases

Stomatognathic Diseases

Bone Density Conservation Agents

All Drugs and Chemicals

Diphosphonates

Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has developed ONJ

Patient with cancer involving the bone treated with osteoclast inhibitor (bisphosphonate) and has NOT developed ONJ

Catherine Van Poznak, MD

This study seeks to identify risk factors associated with the development of a jaw condition seen in patients with cancer treated with certain medications.

The goal of this research is to build an index of risk for estimating an individual's risk of developing osteonecrosis of the jaw (ONJ). The bisphosphonates are an important supportive therapy in the care of patients with metastatic bone disease; they are able to prevent catastrophic events such as fracture and spinal cord compression. However, ONJ has been associated with the use of the bisphosphonates and ONJ carries significant morbidity. Presently, there are insufficient data to calculate the ONJ risk benefit ratio of bisphosphonate use. An ONJ risk assessment tool would improve both the oncologist's and the dental health professional the ability to anticipate and potentially mitigate oral toxicities from bisphosphonate therapy.

This protocol consists of a case (ONJ) control (no ONJ) study to identify factors associated with the risk of ONJ and to build an index predictive of an individual's risk of developing ONJ. The index of ONJ risk will be comprised of clinical, epidemiologic and genetic factors

paraffin embedded tissue block and/or WBC

Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer

National Institute of Dental and Craniofacial Research (NIDCR)

Indiana University

M.D. Anderson Cancer Center

Memorial Sloan Kettering Cancer Center

University of Michigan

Priniciple Investigator

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Breast Neoplasms

Renal Insufficiency

Prostatic Neoplasms

Multiple Myeloma

Neoplasms, Plasma Cell

Bone Neoplasms

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Hormones

Zoledronic Acid

Zoledronic acid

Novartis Pharmaceuticals

This study is designed to monitor the safety and efficacy of long-term treatment with zoledronic acid by assessing the incidence of, renal impairment, osteonecrosis of the jaw(ONJ), overall safety and skeletal related events (SREs) beyond 12 months treatment

Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases

A Phase IV Study of Zoledronic Acid Therapy in Patients With Bone Metastases From Breast Cancer or Hormone Resistant Prostate Cancer, or Bone Involvement From Multiple Myeloma, Assessing Long-term Efficacy and Safety

External Affairs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer	NCT01325142	Bone Diseases Metastases Osteonecrosis Bisphosphonate-...		21 Years -	University of Michigan
Long Term Efficacy and Safety of Zoledronic Acid Treatment in Patients With Bone Metastases	NCT00434447	Bone Neoplasms	Zoledronic acid	18 Years -	Novartis
Genetic Risk of Osteonecrosis of the Jaw (ONJ) in Patients With Metastatic Cancer	NCT01325142	Bone Diseases Metastases Osteonecrosis Bisphosphonate-...		21 Years -	University of Michigan

Spots Global Cancer Trial Database for osteonecrosis of the jaw (onj)