Effectiveness of antiresorptives in preventing hip fractures in older women (≥ 75 years) with osteoporosis: nested case-control study cohort (BiHip)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (M05BA) Bisphosphonates

  (M05BA01) etidronic acid

  (M05BA02) clodronic acid

  (M05BA03) pamidronic acid

  (M05BA04) alendronic acid

  (M05BA05) tiludronic acid

  (M05BA06) ibandronic acid

  (M05BA07) risedronic acid

  (M05BA08) zoledronic acid
• Medical condition to be studied:
  Senile osteoporosis
• Additional medical condition(s):
  Substance abuse, Anxiety, Arrhythmia, Asthma, Ischemic heart disease, Depression, Type II diabetes mellitus, Celiac disease, Chronic obstructive pulmonary disease, Chronic kidney disease, Death, Hypertension, Hyperthyroidism, Hypothyroidism Stroke, Heart failure, Malignant neoplasm, Parkinsonism, Smoking Major, neurocognitive disorder

Population studied

• Age groups:
  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  700000

Study design details

• Main study objective:
  GENERAL OBJECTIVE: To determine the real-life effectiveness of antiresorptive treatment in preventing hip fractures in older women (? 75 years) with osteoporosis.
• Outcomes:
  Hip fracture, Tibia and fibula fracture Nasal bone fracture Wrist fracture Vertebral fracture Humerus fracture
• Data analysis plan:
  We will use conditional logistic regression to estimate adjusted ORs and 95% CIs for the association between antiresorptive exposure and hip fractures. Antiresorptive use will be categorized as exposed vs non-exposed. In separate analyses, current use (current users) versus recent use (recent users) and past use (past users) will also be evaluated. Likewise, continuous and cumulative duration will be evaluated and results analyzed to identify a trend. The established significance level will be p=0.05. In the analysis by duration of exposure, the reference group will be never-users of antiresorptives. If a protective effect is found, an analysis of response duration (time-to-hip-fracture analysis) using log-rank test and Cox regression will be carried out.