Clinical trial NCT04742010: Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)
Official title: Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bone Loss
Muscle Atrophy
Bariatric Surgery
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Research Unit of Health Sciences, Hospital of South West Jutland
name: Department of Regional Health Research, University of Southern Denmark
name: OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark
name: Department of Radiology and Nuclear Medicine, Hospital of Southwest Jutland, 6700 Esbjerg, Denmark
name: Odense University Hospital
First posted: 2021-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 35 years old or older
* Eligible for bariatric surgery (BMI\>35 kg/m2 with obesity-related comorbidity)

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Chronic kidney disease with estimated GFR\<45 ml/min.
* Hypocalcemia .
* Hypersensitivity to bisphosphonates, mannitol, sodium citrate or water.
* Metabolic bone disease (osteoporosis is allowed).
* Prior treatment with anti-osteoporotic agents.
* Treatment with oral glucocorticoids
* Other diseases with known effects on bone metabolism

Primary outcomes:
measure: Quantitative Computed Tomography (QCT)
timeFrame: Change from baseline to 12 and 24 months after bariatric surgery
Secondary outcomes:
measure: QCT
timeFrame: Change from baseline to 12 and 24 months after bariatric surgery
measure: Biochemical calcium-metabolic markers
timeFrame: Change from baseline to 12 and 24 months after bariatric surgery
measure: DEXA
timeFrame: Change from baseline to 12 and 24 months after bariatric surgery
measure: HR-pQCT
timeFrame: Change from baseline to 12 and 24 months after bariatric surgery
measure: Cortical bone stiffness
timeFrame: Change from baseline to 12 and 24 months after bariatric surgery
measure: Muscle Strength
timeFrame: Change from baseline to 12 and 24 months after bariatric surgery
measure: Physical function
timeFrame: Change from baseline to 12 and 24 months after bariatric surgery
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Hospital South West Jutland
Study officials:
References:
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