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

Stinus Gadegaard Hansen

Status and phase: Enrolling; Phase 2

Conditions: Muscle Atrophy; Bariatric Surgery; Bone Loss

Treatments: Drug: Placebo; Drug: Zoledronic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04742010

20/41068

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Zoledronic Acid

Experimental group

Description:

Active treatment

Treatment:

Drug: Zoledronic Acid

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo