Table 3.
Changes in DXA, pQCT, QCT, Bone Biomarker and Muscle Strength Outcomes in the Intention to Treat Analyses
| A | B | C | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Active LMMS (n = 60) | Placebo (n = 61) | P-value for Change in All Participants Combined | Difference in Changes between Groups (95% C.I.)** | P-value for Differences in Changes between Group | |||||
| Baseline | 12 Months | Change | Baseline | 12 Months | Change | ||||
| DXA | |||||||||
| PA spine aBMD Z-score | −1.06 ± 0.97 | −0.88 ± 0.99 | 0.18 ± 0.42 | −1.06 ± 1.13 | −0.97 ± 0.98 | 0.09 ± 0.44 | <0.0005 | 0.05 (−0.07, 0.17) | 0.40 |
| Paired PA lateral spine vBMD Z-score | −0.69 ± 1.19 | −0.54 ± 1.13 | 0.14 ± 0.83 | −0.71 ± 1.45 | −0.57 ± 1.26 | 0.15 ± 0.88 | 0.06 | 0.04 (−0.18, 0.26) | 0.71 |
| Total hip aBMD Z-score | −1.21 ± 0.98 | −0.97 ± 1.02 | 0.24 ± 0.44 | −1.23 ± 0.95 | −0.98 ± 0.89 | 0.26 ± 0.43 | <0.0005 | −0.01 (−0.14, 0.11) | 0.83 |
| Femoral neck aBMD Z-score | −1.26 ± 0.93 | −1.06 ± 0.98 | 0.19 ± 0.45 | −1.34 ± 0.95 | −1.13 ± 0.94 | 0.22 ± 0.45 | <0.0005 | −0.03 (−0.16, 0.10) | 0.66 |
| Whole body BMC Z-score | −0.66 ± 0.99 | −0.46 ± 0.92 | 0.20 ± 0.40 | −0.69 ± 0.81 | −0.51 ± 0.71 | 0.18 ± 0.43 | <0.0005 | 0.02 (−.09, 0.13) | 0.70 |
| Leg lean mass Z-score | −0.97 ± 0.98 | −0.87 ± 1.06 | 0.10 ± 0.68 | −1.00 ± 1.01 | −0.76 ± 1.02 | 0.24 ± 0.56 | <0.0005 | −0.09 (−0.26, 0.08) | 0.29 |
| Tibia pQCT | |||||||||
| Trabecular vBMD Z-score* | −1.69 ± 0.73 | −1.54 ± 0.98 | 0.15 ± 0.55 | −1.87 ± 0.76 | −1.62 ± 0.88 | 0.23 ± 0.70 | <0.0005 | −0.08 (−0.26, 0.10) | 0.38 |
| Cortical vBMD Z-score | −0.10 ± 1.26 | −0.58 ± 1.10 | −0.38 ± 1.01 | −0.14 ± 1.47 | −0.53 ± 1.41 | −0.39 ± 1.07 | <0.0005 | 0.01 (−0.24,0.26) | 0.91 |
| Cortical area Z-score* | −1.44 ± 1.20 | −1.27 ± 1.26 | 0.17 ± 0.58 | −1.45 ± 1.05 | −1.25 ± 0.96 | 0.20 ± 0.59 | < 0.0005 | −0.02 (−0.18, 0.14) | 0.80 |
| Periosteal circ Z-score | −0.84 ± 0.91 | −0.83 ± 1.00 | 0.01 ± 0.26 | −0.75 ± 0.92 | −0.75 ± 0.88 | 0.01 ± 0.27 | 0.76 | 0.00 (−0.07, 0.08) | 0.97 |
| Endosteal circ Z-score | 0.14 ± 1.16 | 0.00 ± 1.11 | −0.13 ± 0.30 | 0.39 ± 1.07 | 0.22 ± 1.09 | −0.17 ± 0.27 | < 0.0005 | 0.02 (−0.06, 0.10) | 0.63 |
| Calf muscle area Z-score | −0.87 ± 1.02 | −0.80 ± 1.04 | 0.07 ± 0.48 | −0.81 ± 0.86 | −0.65 ± 0.89 | 0.15 ± 0.46 | 0.01 | −0.05 (−0.18, 0.08) | 0.42 |
| Spine QCT | |||||||||
| Spine trabecular vBMD Z-score* | −0.78 ± 1.39 | −0.56 ± 1.26 | 0.22 ± 0.59 | −0.74 ± 1.24 | −0.76 ± 1.09 | −0.02 ± 0.67 | 0.09 | 0.24 (0.03, 0.44) | 0.02 |
| Tibia Metaphysis QCT | |||||||||
| Metaphysis Trabecular vBMD, mg/cm3 | 204 ± 36 | 213 ± 40 | 8 ± 21 | 198 ± 31 | 209 ± 34 | 11 ± 16 | <0.0005** | −2 (−9, 5) | 0.53 |
| Bone Biomarkers | |||||||||
| BSAP Z-score | −0.86 ± 1.41 | −0.26 ± 1.28 | 0.60 ± 1.39 | −0.80 ± 1.30 | −0.20 ± 1.56 | 0.44 ± 1.71 | <0.001 | 0.00 (−0.32, 0.32) | 0.98 |
| β-CTX Z-score | 0.19 ± 1.03 | 0.31 ± 0.99 | 0.11 ± 1.15 | 0.26 ± 1.02 | 0.26 ± 1.36 | −0.12 ± 1.30 | 0.99 | 0.22 (−0.12, 0.56) | 0.20 |
| Dynamometer | |||||||||
| Calf muscle strength Z-score | −0.40 ± 0.91 | −0.25 ± 0.92 | 0.13 ± 0.68 | −0.46 ± 0.94 | −0.41 ± 0.87 | 0.09 ± 0.75 | 0.11 | 0.08 (−0.10, 0.27) | 0.38 |
*
Primary outcomes
**
Adjusted for baseline value
PA: posterioanterior
aBMD: areal BMD
vBMD: volumetric BMD
Circ: circumference
**Note, the significant increase in tibia QCT metaphysis trabecular vBMD represents growth and development, at least in part, as these were not converted to Z-scores.