In contrast with bisphosphonates,discontinuation of denosumab results in gradual loss of bone mineral density gains. The investigators aim to evaluate whether in patients treated with denosumab, a single zoledronic acid infusion would prevent the anticipated bone loss.
Discontinuation of denosumab results in a rebound rise of bone turnover markers and gradual loss of the achieved bone mineral density gains. In contrast, bisphosphonates, such as zoledronic acid, remain within the skeleton acting for several months or even years after discontinuation while maintaining bone mineral density despite the cessation of treatment. In this study, the investigators aim to evaluate changes in bone mineral density of the lumbar spine and the femoral neck, as well as in bone turnover markers one year after treatment discontinuation both in denosumab-treated women and in denosumab-treated women who switched to zoledronic acid infusion one year before treatment discontinuation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Treatment of low bone mass with subcutaneous injections of denosumab 60 mg every 6 months for one year
Treatment of low bone mass with a single infusion of zoledronic acid 5 mg for one year
251 Airforce & VA General Hospital
Athens, Greece
424 General Military Hospital
Thessaloniki, Greece
bone mineral density of the lumbar spine
differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry
Time frame: from 12 to 24 months
bone mineral density of the femoral neck
differences between the 2 arms in the changes of femoral neck bone mineral density measured by dual-energy X-ray absorptiometry
Time frame: from 12 to 24 months
C-terminal telopeptide of type I collagen
differences between the 2 arms in the changes of C-terminal telopeptide of type I collagen
Time frame: from 12 to 15, 18, 24 months
propeptide of procollagen type I
differences between the 2 arms in the changes of propeptide of procollagen type I
Time frame: from 12 to 15, 18, 24 months
bone mineral density of the lumbar spine
differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry
Time frame: from baseline to 12 months
bone mineral density of the femoral neck
differences between the 2 arms in the changes of femoral neck bone mineral density measured by dual-energy X-ray absorptiometry
Time frame: from baseline to 12 months
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