Table 2.
Study variables, instruments, and rationale for use
| 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 |
a25(OH)D testing only