title: Long-term follow-up of patients on drug holiday from bisphosphonates: real-world setting.
abstract: OBJECTIVE
  Atypical femoral fractures and osteoporosis of the jaw have been associated with prolonged bisphosphonate therapy for postmenopausal osteoporosis. American Association of Clinical Endocrinologists guidelines suggest a drug holiday after 4 to 5 years of bisphosphonate treatment for moderate-risk patients and 10 years for high-risk patients, but there are minimal data on safe holiday durations. A recent U. S. Food and Drug Administration perspective suggests a treatment duration of 3 to 5 years. Our aim was to describe a group of patients on drug holiday and identify fracture risk.
  
  
  METHODS
  A retrospective chart review was conducted of 209 patients who started a bisphosphonate drug holiday between 2005 and 2010. Collected data included bone mineral density (BMD), markers of bone turnover, vitamin D status, and clinical and radiographic reports of fractures.
  
  
  RESULTS
  Eleven of 209 patients (5.2%) developed a fracture. Their mean age was 69.36 years (±15.58), and the mean lumbar spine and femoral neck T-scores were -2.225 (±1.779) and -2.137 (±0.950), respectively. All patients had a significant increase in bone-specific alkaline phosphatase at 6 months, which was more pronounced in the fracture group (3.0 ± 0.6083 μg/L vs. 1.16 ± 1.9267 μg/L). Over 4 years, there was no significant change in mean lumbar spine BMD for the entire cohort, but there was a statistically significant decline in the femoral neck BMD at year 2 (-0.0084 ± 0.03 gm/cm2).
  
  
  CONCLUSIONS
  The current practice of initiating BP holidays needs further evaluation, particularly in the real-world setting. Elderly patients and those with very low BMD warrant close follow-up during a drug holiday. A fracture, early significant rise in bone turnover markers, and/or a decline in BMD should warrant resumption of osteoporosis therapy.
authors.affiliation: Department of Endocrinology and Metabolism, Loyola University Medical Center.
authors.forename: Maguy
authors.initials: M
authors.lastname: Chiha
authors.forename: Lauren E
authors.initials: LE
authors.lastname: Myers
authors.forename: Caroline A
authors.initials: CA
authors.lastname: Ball
authors.forename: James M
authors.initials: JM
authors.lastname: Sinacore
authors.forename: Pauline M
authors.initials: PM
authors.lastname: Camacho
mesh_terms: D015502:Absorptiometry, Photon; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000469:Alkaline Phosphatase / Q000032:analysis; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001851:Bone Diseases, Metabolic / Q000150:complications / Q000188:drug therapy; D001842:Bone and Bones / Q000201:enzymology; D015331:Cohort Studies; D004164:Diphosphonates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005272:Femur Neck / Q000033:anatomy & histology; D005500:Follow-Up Studies; D050723:Fractures, Bone / Q000453:epidemiology; D006801:Humans; D008159:Lumbar Vertebrae / Q000033:anatomy & histology; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy; D012189:Retrospective Studies; D014807:Vitamin D / Q000378:metabolism / Q000627:therapeutic use; D014815:Vitamins / Q000378:metabolism / Q000627:therapeutic use
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D014815:Vitamins; D014807:Vitamin D; D000469:Alkaline Phosphatase