NCT04742010

Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Stinus Gadegaard Hansen · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Loss
• Muscle Atrophy
• Bariatric Surgery

Interventions

Type	Name	Description
DRUG	Zoledronic Acid	* 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
DRUG	Placebo	as above

Timeline

• Start date: 2021-02-20
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2021-02-05
• Last updated: 2022-06-10

Locations

1 site across 1 country: Denmark