Abstract :
[en] We analyzed the relationships between bone
mineral density (BMD) or bone turnover marker (BTM)
changes and vertebral fracture incidence in women treated
with bazedoxifene using a post hoc analysis from a 3-year
randomized, placebo-controlled study evaluating the effect
of bazedoxifene (20 or 40 mg) on fracture risk reduction.
BMD was assessed at baseline and every 6 months for
3 years. Osteocalcin and C-telopeptide of type I collagen
were assessed at baseline and at 3, 12, and 36 months.
Vertebral fractures were assessed with a semiquantitative
visual assessment. Data were available for 5,244 women, of
whom 3,476 were treated with bazedoxifene. Using a
logistic regression analysis and the classical Li approach,
the proportion of fracture incidence explained by BMD
change after 3 years of bazedoxifene treatment was 29 %
for the total hip and 44 % for the femoral neck. The proportion
of treatment explained by lumbar BMD change
could not be quantified accurately because of the significant
interaction between treatment and change in BMD. With
the same model, the 12-month BTM changes explained up
to 29 % of the fracture risk reduction observed with the two
forms of bazedoxifene. In women treated with bazedoxifene,
changes in femoral neck BMD, hip BMD, or BTMs
explained a moderate proportion of the fracture risk
reduction observed during the 3 years of follow-up. However,
BMD or BTM changes cannot be recommended for
individual monitoring of women treated with bazedoxifene.
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