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Table 1 Primary and secondary endpoints

From: Zoledronic Acid for prevention of bone and muscle loss after BAriatric Surgery (ZABAS)-a study protocol for a randomized controlled trial

 

Measurement

Site

Time (months)

Primary endpoints

 vBMD

QCT

Lumbar spine (L1–L2)

12

Secondary Endpoints

 vBMD

QCT

Lumbar spine (L1–L2)

24

 vBMD

QCT

Proximal femur

12 and 24

 aBMD

DXA

Hip

Lumbar spine

12 and 24

 Lean and fat mass

DXA

Whole body

12 and 24

 Bone microarchitecture

HR-pQCT

Distal radius

Distal tibia

12 and 24

 Cortical bone strength

Microindentation

Mid tibia

12 and 24

 Biochemical markers of bone remodeling

CTX1

P1NP

Blood

12 and 24

 Muscle strength

Dynamometer

Handgrip

Knee extension/flexion

Foot dorsi/plantar flexion

Shoulder elevation

12 and 24

 Physical function

SPPB

T25FWT

2MWT

Stair climb

 

12 and 24

 Physical activity

IPAQ

 

12 and 24

  1. Time is measured in months; QCT Quantitative computed tomography, DXA Whole-body dual-energy X-ray absorptiometry, HR-pQCT High-resolution peripheral quantitative computed tomography, CTX-1 Carboxy-terminal type-1 collagen, P1NP Procollagen type-1 amino-terminal propeptide, SPPB Short Physical Performance Battery, T25FWT Timed 25-ft walk test, 2MWT 2-min walk test, IPAQ The International Physical Activity Questionnaire