A Phase 2 interventional study of Zoledronic Acid and Placebo in Bone Loss, Muscle Atrophy and Bariatric Surgery, sponsored by Stinus Gadegaard Hansen. Completed at 1 site in Denmark. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Stinus Gadegaard Hansen · Phase 2, Interventional, and Treatment
In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.
In individuals with severe obesity, bariatric surgery effectively reduces body weight, improves obesity related diseases and lowers mortality. A loss of bone and muscle mass and an increase in bone fracture risk are however seen after surgery. In this study it is examined if treatment with zoledronic acid (a drug used to treat osteoporosis) can prevent the bone and muscle loss after bariatric surgery. A single infusion of zoledronic acid or placebo is given before surgery. The study is blinded and randomized for methodological reasons. Bone and muscle scans, tests of muscle strength and physical performance and blood samples (for analysis of markers related to bone and muscle metabolism) are performed at inclusion and 12 and 24 months after surgery. A total of 60 adult individuals will participate. Results will be important for the evidence-based care of patients undergoing bariatric surgery and zoledronic acid.
Study design This is a single center randomized double-blind placebo-controlled study of zoledronic acid for prevention of bone and muscle loss after bariatric surgery. Routine bariatric surgery (RYGB or gastric sleeve) will be performed. The end of study is 24 months after surgery.
Study Population Patients referred for bariatric surgery at The Hospital South West Jutland, Esbjerg will be invited to participate.
Randomization After inclusion and baseline assessment, patients will be randomly assigned to either zoledronic acid or placebo with a 1:1 allocation. A randomization code stratifying an equal number of participants having RYGB or SG into each study arm will be applied.
470 studies on the registry are indexed under Bone Diseases, Metabolic; 71 are open to participants now.
This study's enrollment of 59 is close to the median of 60 across 359 interventional studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →This is the only study on the registry with Stinus Gadegaard Hansen as lead sponsor.
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Exclusion Criteria:
Active treatment
Drug: Zoledronic Acid
Placebo
Drug: Placebo
* A single treatment 21 days before bariatric surgery with Zoledronic acid 5 mg or placebo (an interval of 5 to 180 days is accepted) * Pharmaceutical form: Solution for infusion (100 ml normal saline containing 5 mg zoledronic acid or placebo) * Administration: slow intravenous infusion with a duration of at least 15 minutes
as above
Quantitative Computed Tomography (QCT)
Volumetric bone mineral density at the lumbar spine (L1 -L2) (Mindways QCT Pro software, Texas, USA).
Time frame: Change from baseline to 12 and 24 months after bariatric surgery
QCT
Volumetric BMD at the proximal femur (Mindways QCT Pro software, Texas, USA).
Time frame: Change from baseline to 12 and 24 months after bariatric surgery
Biochemical calcium-metabolic markers
Calcium, parathyroid hormone, vitamin D and markers of bone remodeling (CTX, P1NP).
Time frame: Change from baseline to 12 and 24 months after bariatric surgery
DEXA
Bone mineral density at the lumbar spine and total hip (Hologic Discovery, Waltham, MA, US).
Time frame: Change from baseline to 12 and 24 months after bariatric surgery
HR-pQCT
Radius and tibia bone microarchitecture (Scanco Medical AG, Brutisellen, Switzerland).
Time frame: Change from baseline to 12 and 24 months after bariatric surgery
Cortical bone stiffness
Cortical bone material strength index (BMSi) assessed using microindentation at the anterior surface of the mid-tibia diaphysis (OsteoProbe, Active Life Scientific, California, US).
Time frame: Change from baseline to 12 and 24 months after bariatric surgery
Muscle Strength
Upper and lower limb muscle strength assessed using dynamometers (foot, knee, shoulder, hand)
Time frame: Change from baseline to 12 and 24 months after bariatric surgery
Physical function
Short physical performance battery (SPPB), Stair Climb, 2 minute walking test
Time frame: Change from baseline to 12 and 24 months after bariatric surgery
Plan to share: No
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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