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Table 2 Primary and secondary endpoints

From: The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial

 

Measurement

Site

Time (months)

Primary endpoints

 Δ Bone mineral density

DXA

Total hip

Spinal region

12

Secondary endpoints

 Δ Bone mineral density

DXA

Total hip

Spinal region

6, 18, and 24

 Δ Bone microarchitecture

HR-pQCT

Distal radius

Distal tibia

6, 12, 18, and 24

 Δ Bone biomarkers

P1NP

CTX, sclerostin

Serum

3, 6, 12, 18, and 24

 Δ Physical biomarkers

TUG

SPPB

 

3, 6, 12, 18, and 24

Dynamometer

Hand grip

Nottingham power rig

Leg extensor

 Δ Quality of life

EQ-5D

 

12 and 24

 Δ Fear of falling

FES-I

 

12 and 24

 Physical activity

IPAQ

 

0, 12, and 24

 Adherence to WBV

Training logbook

 

Continuously

 Falls

Falls calendar

 

Continuously

  1. Δ change from baseline; Time is measured in months; DXA dual-energy x-ray absorptiometry; HR-pQCT high-resolution peripheral quantitative computed tomography; P1NP procollagen type-1 amino-terminal propeptide; CTX carboxy-terminal type-1 collagen crosslinks; TUG Timed Up and Go; SPPB Short Physical Performance Battery; FES-I Falls Efficacy Scale International; IPAQ The International Physical Activity Questionnaire; EQ-5D EuroQoL 5-dimension, 5-level questionnaire, WBV whole-body vibration