Table 2.
Percent change in BMD at the spine (L1–L4), hip and femoral neck, compared between the immediate and deferred ART groups by intent-to-treat.
| Spine (L1–L4) | Immediate ART Group | Deferred ART | Immediate - Deferred ART Groups | |||
|---|---|---|---|---|---|---|
| N | Mean (95% CI) | N | Mean (95% CI) | Estimated Difference (95% CI) | P | |
| Baseline to Year 1 | 194 | −2.04 (−2.46, −1.62) | 197 | −0.32 (−0.71, 0.07) | −1.72 (−2.29, −1.14) | <0.001 |
| Baseline to Year 2 | 169 | −1.74 (−2.28, −1.21) | 180 | −0.33 (−0.87, 0.22) | −1.41 (−2.18, −0.65) | <0.001 |
| Baseline to Year 3 | 51 | −2.45 (−3.41, −1.48) | 59 | −0.29 (−1.33, 0.75) | −2.16 (−3.60, −0.71) | <0.01 |
|
| ||||||
| Overall | 195 | −1.92 (−2.34, −1.50) | 204 | −0.35 (−0.76, 0.06) | −1.57 (−2.16, −0.98) | <0.001 |
|
| ||||||
| Change from Year 1 to Year 2 (%) | 168 | 0.29 (−0.16, 0.74) | 173 | −0.10 (−0.54, 0.35) | 0.39 (−0.25, 1.03) | 0.23 |
| Change from Year 2 to Year 3 (%) | 50 | 0.25 (−0.54, 1.03) | 59 | −0.49 (−1.21, 0.23) | 0.78 (−0.31, 1.86) | 0.16 |
|
| ||||||
| Rate of change after Year 1 (% per year) | 0.24 (−0.11, 0.59) | −0.17 (−0.51, 0.16) | 0.42 (−0.07, 0.90) | 0.10 | ||
|
| ||||||
| Total Hip | ||||||
|
| ||||||
| Baseline to Year 1 | 193 | −2.03 (−2.57, −1.50) | 197 | −0.49 (−0.87, −0.11) | −1.54 (−2.21, −0.88) | <0.001 |
| Baseline to Year 2 | 169 | −2.93 (−3.62, −2.23) | 180 | −1.30 (−1.90, −0.69) | −1.58 (−2.50, −0.65) | <0.001 |
| Baseline to Year 3 | 51 | −3.58 (−4.46, −2.70) | 58 | −1.94 (−3.14, −0.73) | −1.57 (−3.09, −0.04) | 0.05 |
|
| ||||||
| Overall | 194 | −2.53 (−3.03, −2.02) | 204 | −0.99 (−1.48, −0.49) | −1.53 (−2.24, −0.82) | <0.001 |
|
| ||||||
| Change from Year 1 to Year 2 (%) | 168 | −0.97 (−1.45, −0.49) | 173 | −0.81 (−1.28, −0.34) | −0.11 (−0.79, 0.57) | 0.75 |
| Change from Year 2 to Year 3 (%) | 50 | 0.03 (−0.64, 0.69) | 58 | −0.96 (−1.58, −0.34) | 1.03 (0.11, 1.95) | 0.03 |
|
| ||||||
| Rate of change after Year 1 (% per year) | −0.74 (−1.12, −0.36) | −0.84 (−1.20, −0.47) | 0.15 (−0.38, 0.68) | 0.58 | ||
|
| ||||||
| Femoral Neck | ||||||
|
| ||||||
| Baseline to Year 1 | 193 | −2.49 (−3.11, −1.86) | 197 | −0.62 (−1.15, −0.08) | −1.96 (−2.78, −1.14) | <0.001 |
| Baseline to Year 2 | 169 | −3.41 (−4.27, −2.54) | 180 | −2.02 (−2.78, −1.27) | −1.46 (−2.61, −0.32) | 0.01 |
| Baseline to Year 3 | 51 | −3.66 (−5.08, −2.25) | 58 | −2.36 (−3.78, −0.95) | −1.32 (−3.34, 0.69) | 0.20 |
|
| ||||||
| Overall | 194 | −3.02 (−3.64, −2.40) | 204 | −1.44 (−2.05, −0.83) | −1.70 (−2.57, −0.83) | <0.001 |
|
| ||||||
| Change from Year 1 to Year 2 (%) | 168 | −1.00 (−1.63, −0.37) | 173 | −1.46 (−2.08, −0.84) | 0.46 (−0.42, 1.35) | 0.30 |
| Change from Year 2 to Year 3 (%) | 50 | −0.32 (−1.37, 0.74) | 58 | −0.58 (−1.56, 0.40) | 0.25 (−1.21, 1.71) | 0.74 |
|
| ||||||
| Rate of change after Year 1 (% per year) | −0.87 (−1.37, −0.38) | −1.23 (−1.70, −0.75) | 0.36 (−0.33, 1.06) | 0.30 | ||
Follow-up was censored at the start of osteoporosis therapy for 2 participants (both in the deferred group, month 24). Mean changes in BMD from baseline to each year were calculated without adjustments, differences at each year were estimated in regression models adjusted for baseline BMD, and overall changes in BMD were estimated and compared using longitudinal mixed models adjusted for both baseline BMD and visit. Rates of changes in spine BMD after year 1 were estimated in longitudinal mixed models using annual BMD changes as response.