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

Phase 2

• Conditions: Bone Loss; Muscle Atrophy; Bariatric Surgery
• Interventions: Drug: Placebo; Drug: Zoledronic Acid

• Registration Number: NCT04742010
• Lead Sponsor: Stinus Gadegaard Hansen

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.

Study Timeline

• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-05
• Study Start: 2021-02-20
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-08
• Last Update Posted: 2022-06-10
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Zoledronic Acid	Zoledronic Acid	Active treatment

Primary Outcome Measures

Name	Time	Method
Quantitative Computed Tomography (QCT)	Change from baseline to 12 and 24 months after bariatric surgery	Volumetric bone mineral density at the lumbar spine (L1 -L2) (Mindways QCT Pro software, Texas, USA).

Secondary Outcome Measures

Name	Time	Method
Biochemical calcium-metabolic markers	Change from baseline to 12 and 24 months after bariatric surgery	Calcium, parathyroid hormone, vitamin D and markers of bone remodeling (CTX, P1NP).
Cortical bone stiffness	Change from baseline to 12 and 24 months after bariatric surgery	Cortical bone material strength index (BMSi) assessed using microindentation at the anterior surface of the mid-tibia diaphysis (OsteoProbe, Active Life Scientific, California, US).
Muscle Strength	Change from baseline to 12 and 24 months after bariatric surgery	Upper and lower limb muscle strength assessed using dynamometers (foot, knee, shoulder, hand)
QCT	Change from baseline to 12 and 24 months after bariatric surgery	Volumetric BMD at the proximal femur (Mindways QCT Pro software, Texas, USA).
DEXA	Change from baseline to 12 and 24 months after bariatric surgery	Bone mineral density at the lumbar spine and total hip (Hologic Discovery, Waltham, MA, US).
HR-pQCT	Change from baseline to 12 and 24 months after bariatric surgery	Radius and tibia bone microarchitecture (Scanco Medical AG, Brutisellen, Switzerland).
Physical function	Change from baseline to 12 and 24 months after bariatric surgery	Short physical performance battery (SPPB), Stair Climb, 2 minute walking test

Trial Locations

Locations (1)

Hospital South West Jutland; 🇩🇰 Esbjerg, Denmark