Novartis Pharmaceuticals Corporation

59 Route 10

East Hanover, NJ 07936

 

 

Appendix: 1
Risk Factors/Conditions for Osteonecrosis

 

 

Zometa® (zoledronic acid) Injection

and

Aredia® (pamidronate disodium) Injection

Submitted:  February 1, 2005

 

 

Oncologic Drugs Advisory Committee Meeting

March 4, 2005

 

 

Property of Novartis Pharmaceuticals Corporation
All rights reserved
Available for public disclosure without redaction

 

 

 

Table of contents

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

 


1                            Conditions leading to or associated with osteonecrosis

(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

 

2                            Localized and systemic diseases and pathophysiologic processes associated with ischemic osteonecrosis

(from [Bouquot and McMahon (2000)] Neuropathic pain in maxillofacial osteonecrosis. J Oral Maxillofoc Surg 58: 1003-1020)

DISEASE OR
ETIOLOGIC
FACTOR

 

SUBCATEGORIES

DISEASE OR ETIOLOGIC FACTOR

 

SUBCATEGORIES

Alcohol abuse

Arthritis


Atmospheric pressure variations


Blood dyscrasias




Cancer









Chronic inactivity


Corticosteroids





Estrogen





Gaucher’s disease Hemodialysis
Hypercoaguable state,
local

Cirrhosis
Pancreatitis
Subchondral cyst
Subchondral marrow edema

Caisson’s disease
Deep sea diving

Disseminated intravascular coagulation
Leukemia
Sickle cell anemia
Chemotherapy for cancer
Cancer-induced hyperocoagulation
Lymphoma
Metastatic intraosseous carcinoma
Radiation therapy for cancer
Bedridden
Full body cast
Paraplegic
Hypercortisolism
Inflammatory bowel disease
Lupus erythematosus
Transplants
Birth control pills
Estrogen replacement therapy
Fertility drugs
Pregnancy
Prostate chemotherapy
Transient ischemic osteoporosis




Acute infection/inflammation Chronic infection/inflammation
Chronic infection/inflammation Increased intrame-dullary pressures

Hypercoagulable state, systemic






Hyperdipidemia and embolic fat






Hypersensitivity reactions






Hypertension Hypothyroidism Inflammation, intraosseous



Lupus erythematosus


Neurodamage Osteoporosis
Starvation
Storage diseases
Tobacco use
Vascular occlusive disease
Vasculitis
Vasoconstriction

Antiphospholipid antibody syndrome Factor VLeiden gene mutation Hyperhomocystinemia Homozygosity for MTHFR or CBS Protein C deficiency
Protein S deficiency


Diabetes mellitus
Dysbaric phenomena
Fracture of bone
Hemoglobinopathies
Osteomyelitis, acute



Allograft organ rejection
Anaphylactic shock
Immune globulin therapy
Shwartzman reaction to endotoxin
Transfusion reactions


Infection, bacterial and viral
Trauma (mild or severe)
Autoimmunity/hypersensitivity
With corticosteroid therapy
Without corticosteroid therapy
Brain injury/surgery
Regional or generalized
Anorexia nervosa
Gaucher’s disease
Tobacco smoking







Atherosclerosis


Local anesthetic use
Raynaud phenomenon