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Table 2 Study variables, instruments, and rationale for use

From: Protocol for a randomized controlled trial to compare bone-loading exercises with risedronate for preventing bone loss in osteopenic postmenopausal women

Measure Purpose Baseline 3 months 6 months 12 months
Demographic profile and health history [3] Demographic data and medical history to describe sample and identify potential covariates X    
Physical activity readiness questionnaire (PARQ) Predicts the need for medical clearance for initiating exercise X    
Calcium, PTH, 25(OH)D, TSH, Creatinine (Cr) [27] To identify abnormalities which exclude participation, and serum Vit D informs prescription for dosage of Vit D X Xa Xa  
National Osteoporosis Foundation Calcium Intake Estimate Calculates dietary intake of calcium based on servings of calcium-rich food per day X    
Fracture risk Assessment tool (FRAX) [3] Estimates 10 year risk of osteoporotic fracture X    
Incidence of Fractures Documentation Form Incidence, type, cause, treatment of fracture X X X X
International Physical Activity Questionnaire (IPAQ) Data used at baseline to stratify subjects by exercise history prior to randomization to group X   X X
Adherence to CaD, risedronate, exercises [29] Documentation of unused tablets in individual bubbles of returned medication cards or prescribed exercise sessions attended X X X X
Task and Barrier Self-Efficacy Scales [3335] Data collected on subject confidence in ability to perform interventions (CaD, exercises, risedronate) X X X X
One Repetition Maximum (1 RM) Maximum weight lifted once through full range of motion (ROM) to measure muscle strength X X   
Barriers Interference [34, 35] Barriers to exercise adherence perceived by subjects X X X X
Dual-Energy X-Ray Absorptiometry (DXA) [37] BMD at total hip, femoral neck, and spine X   X X
Peripheral Quantitative Computed Tomography (pQCT) [12] Bone Strength Index (BSI) at 4 % & 66 % sites non- dominant tibia, Stratec XCT 3000 X   X X
Serum Biomarkers of Bone Turnover [36, 40] AlkphaseB (U/C) & Serum NTX (nmol BCE/L), assesses rate of bone formation and resorption X   X X
Hip Structural Analysis (OASIS-APEX Workstation + APEX 4.0.X software and Hologic DX44) [39, 47] HSA of femoral neck, femoral shaft, and intertrochanteric is a measure of hip structure calculated from the DXA result X   X X
  1. a25(OH)D testing only