Definitions
Romosozumab, bisphosphonates, teriparatide, and denosumab, which widely
used to treat osteoporosis, were investigated regardless of whether the
data reporter suspected possible adverse events. Bisphosphonates were
defined as alendronate, etidronate, ibandronate, minodronate, and
risedronate: only oral bisphosphonate users were included based on
earlier studies.4,6 The patient selection process is
shown in Fig 1.
Cardiac and cerebrovascular events were evaluated. Cardiac events were
defined by the Preferred Terms “myocardial infraction,” and/or
“angina pectoris,” and cerebrovascular events by the Preferred Term
“cerebral infarction,” in REAC. Data on sex, age, and presence of
cardiac disease, cerebrovascular disease, hypertension, and diabetes
were collected from DEMO. Cardiac
disease was defined as identified comorbidities, including the reported
Preferred Terms ”heart failure,” and/or ”angina pectoris,” and/or
”atrial fibrillation,” in HIST. These comorbidities have been reported
to be associated with development of cardiac
disease.7-9 Cerebrovascular disease was defined as
identified comorbidities, including the reported Preferred Terms
“cerebral infarction,” in HIST. Hypertension and diabetes were defined
as identified comorbidities, including ”hypertension” and/or ”diabetes,”
in HIST respectively. Duplicate reports from patients with non-oral
bisphosphonate users and concomitant use of osteoporosis drugs and were
excluded.