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Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)
Sponsor: Aarhus University Hospital
Summary
The aims of ZOLARMAB2 are fourfold. First, the investigators want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronate at fixed time-points after the last injection of denosumab or when bone turnover is increased. Second, the investigators want to investigate if bone loss will resume after controlling the rebound activation of bone turnover during the first year after denosumab discontinuation and if this can be prevented by yearly infusions of zoledronate. Third, the investigators want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, osteoclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate. Fourth, the investigators want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.
Key Details
Gender
FEMALE
Age Range
40 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-05-10
Completion Date
2027-02-01
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
Zoledronate
zoledronate 5 mg
Placebo
isotonic saline 100 mL
Locations (1)
Aarhus University Hospital
Aarhus, Denmark