The Effects of Inhaled Glucocorticoids on the Postmenopausal Skeleton
Status:
Withdrawn
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
Summary
There are over 10 million individuals with asthma using inhaled glucocorticoids (IGCs) in the
United States. While oral GCs are recognized to have destructive skeletal effects, far less
is known about the effects of IGCs. This gap in our knowledge is of critical importance, not
only because of the prevalence, chronic nature and long duration of IGC use, but also because
several studies have found that patients using IGCs are at increased risk of fracture.
Fracture risk is greatest in postmenopausal (PM) women, in whom IGCs may augment negative
effects of estrogen loss and aging.
The investigators hypothesize that initiation of IGCs in IGC naïve PM women will lead to
decreased bone formation and uncoupling of bone turnover, a potential mechanism for the
effect of IGCs on the skeleton.
To test our hypothesis, the investigators will perform a randomized, controlled 4 week study
of the acute effects of commonly used doses of budesonide (360 or 720 mcg) on bone turnover
and circulating osteoblast precursors in 60 treatment naïve, non-asthmatic, PM women. These
studies are of high clinical significance because there are currently no guidelines regarding
screening, prevention or treatment for osteoporosis in patients using IGCs, nor is IGC use
taken into account when calculating fracture risk in PM women, the group at highest risk of
fracture. High quality evidence for low volumetric bone mineral density (BMD) and abnormal
bone quality in PM women using IGCs has the potential to change clinical practice by
supporting specific interventions to prevent bone loss and fractures.