Postmenopausal Osteoporosis
Conditions
Keywords
osteoporosis, denosumab, zoledronic acid, bone mineral density, bone markers
Brief summary
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.
Detailed description
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.
Interventions
DRUGDenosumab
Treatment of low bone mass with subcutaneous injections of denosumab 60 mg every 6 months for one year
DRUGZoledronic acid
Treatment of low bone mass with a single infusion of zoledronic acid 5 mg for one year
Sponsors
251 Hellenic Air Force & VA General Hospital
Leiden University Medical Center
424 General Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* postmenopausal women * osteopenic (T-score \> -2.5 but \< -1.0) after treatment with denosumab
Exclusion criteria
* secondary osteoporosis; * diseases that could affect bone metabolism; * medications that could affect bone metabolism; * history of any antiosteoporotic treatment other than denosumab prior to randomization * severe liver or kidney disease (creatinine clearance \< 60ml/min/1.73m2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density of the lumbar spine | from 12 to 24 months | differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bone mineral density of the femoral neck | from 12 to 24 months | differences between the 2 arms in the changes of femoral neck bone mineral density measured by dual-energy X-ray absorptiometry |
| C-terminal telopeptide of type I collagen | from 12 to 15, 18, 24 months | differences between the 2 arms in the changes of C-terminal telopeptide of type I collagen |
| propeptide of procollagen type I | from 12 to 15, 18, 24 months | differences between the 2 arms in the changes of propeptide of procollagen type I |
| bone mineral density of the lumbar spine | from baseline to 12 months | differences between the 2 arms in the changes of lumbar spine bone mineral density measured by dual-energy X-ray absorptiometry |
Countries
Greece
Outcome results
None listed