Novartis Pharmaceuticals Corporation
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Appendix: 1
Risk Factors/Conditions for Osteonecrosis
Zometa®
(zoledronic acid) Injection
and
Aredia®
(pamidronate disodium) Injection
Submitted:
Oncologic Drugs
Advisory Committee Meeting
Property of Novartis Pharmaceuticals Corporation
All rights reserved
Available for public disclosure without
redaction
Table of
contents................................................................................................................... 2
1.... Conditions leading to or associated with osteonecrosis............................................................ 3
2.... Localized and systemic diseases and pathophysiologic
processes associated with ischemic osteonecrosis 4
(From: [Assouline-Dayan, et al (2002)] Pathogenesis and natural history of osteonecrosis. Sem Arthr & Rheum 32: 94-124)
|
Trauma |
Disorders |
|
Burns |
Systemic Lupus Erythematosus |
|
Fractures |
Polymyositis |
|
Dislocations |
Polymyalgia Rheumatica |
|
Vascular Trauma |
Raynaud’s Disease |
|
Kienböck Disease |
Rheumatoid Arthritis |
|
Non-Traumatic Conditions |
Ankylosing Spondylitis |
|
Hematologic |
Sjögren’s
Syndrome |
|
Hemoglobinopathies |
Giant Cell Arteritis |
|
Sickle-Cell Anemia |
Thrombophlebitis |
|
Thalassemias |
Lipid Emboli |
|
Disseminated Intravascular Coagulation |
Ehler-Danlos Syndrome |
|
Polycythemia |
Orthopedic Problems |
|
Hemophilia |
Slipped Capital Femoral Epiphysis |
|
Metabolic/Endocrinologic |
Congenital Hip Dislocation |
|
Hypercholesterolemia |
Hereditary Dysostosis |
|
Gout |
Legg-Calvé-Perthes’ Disease |
|
Hyperparathyroidism |
Extrinsic Dietary or
Environmental Factors |
|
Hyperlipidemia |
Dysbaric Conditions (Caisson Disease) |
|
Pregnancy |
Alcohol Consumption |
|
Cushing’s Disease |
Cigarette Smoking |
|
Chronic Renal Failure |
Iatrogenic |
|
Gaucher’sDisease |
Corticosteroids |
|
Diabetes (in association with obesity) |
Radiation Exposure |
|
Fabry’s Disease |
Hemodialysis |
|
Gastrointestinal |
Organ Transplantation |
|
Pancreatitis |
Laser Surgery |
|
Inflammatory Bowel Disease |
Idiopathic |
|
Neoplastic |
|
|
Marrow Infiltrative Disorders |
|
|
Infectious |
|
|
Osteomyelitis |
|
|
Human Immunodeficiency Virus |
|
|
Meningococcemia |
|
|
Vascular/Rheumatologic/Connective
Tissue |
|
(from [Bouquot and McMahon (2000)]
Neuropathic pain in maxillofacial osteonecrosis. J Oral Maxillofoc Surg 58:
1003-1020)
|
DISEASE OR |
SUBCATEGORIES |
DISEASE OR ETIOLOGIC FACTOR |
SUBCATEGORIES |
|
Alcohol abuse |
Cirrhosis |
Hypercoagulable state, systemic |
Antiphospholipid
antibody syndrome Factor VLeiden gene mutation Hyperhomocystinemia
Homozygosity for MTHFR or CBS Protein C deficiency |