Adverse events and intravenous versus oral bisphosphonate use in patients with osteoporosis and cancer in the U.S.
This observational study utilized a patient-level database of more than 55 million patients and 70 U.S.-based health plans compiled from 2000-2006. Patients diagnosed with osteoporosis or various cancers were categorized according to bisphosphonate use (via IV, oral, or none). Continuous enrollment for at least six months pre- and post-index diagnosis was required. Outcomes of adverse events were defined as inflammatory conditions of the jaw, including osteonecrosis; major jaw surgery for necrotic or inflammatory conditions; or jaw surgeries for malignancies. Propensity scores and multivariate regression analyses were used to determine adjusted odds ratios for adverse events based on IV or oral bisphosphonate use relative to no bisphosphonate use, controlling for patient demographics, co-morbidities, prior dental or oral surgery, physician likelihood of prescribing oral versus IV bisphosphonates, and antibiotic, hormonal treatment, or thalidomide use. Subgroup analyses-excluding patients using oral corticosteroids-were conducted. After controlling for numerous demographic, clinical, and instrumental variables, this study found significant relationships between IV bisphosphonate use and both inflammatory conditions of the jaw and major jaw surgery for necrotic or inflammatory conditions in patients with osteoporosis or various cancers. While no significant relationship was observed for oral bisphosphonates, continued research is warranted to assess the long-term use of the medications and adverse events in patients with osteoporosis.
University of Arizona, Tucson, AZ, USA.
Grant H
GH
Skrepnek
Brian
B
Seal
Muralikrishna
M
Tangirala
Marjorie K
MK
Jeffcoat
Nelson B
NB
Watts
Joel W
JW
Hay
D000284:Administration, Oral; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000368:Aged; D019386:Alendronate / Q000008:administration & dosage / Q000009:adverse effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy; D019992:Databases as Topic; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects*; D012968:Etidronic Acid / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects; D007275:Injections, Intravenous / Q000706:statistics & numerical data; D007571:Jaw Diseases / Q000139:chemically induced / Q000453:epidemiology; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy; D009369:Neoplasms / Q000188:drug therapy*; D019647:Oral Surgical Procedures / Q000706:statistics & numerical data; D010000:Osteitis / Q000139:chemically induced / Q000453:epidemiology; D010019:Osteomyelitis / Q000139:chemically induced / Q000453:epidemiology; D010024:Osteoporosis / Q000188:drug therapy*; D000077268:Pamidronate; D015995:Prevalence; D011471:Prostatic Neoplasms / Q000188:drug therapy; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D000077211:Zoledronic Acid
D000305:Adrenal Cortex Hormones; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid; D012968:Etidronic Acid; D000077268:Pamidronate; D019386:Alendronate