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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 [33–35]

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