SF-36 Domain . | Placebo (n=39) . | rhPTH(1-84) (n=83) . | rhPTH(1-84) vs Placebo . | ||||||
---|---|---|---|---|---|---|---|---|---|
Baseline . | Week 24 . | LS Mean Change (SE)a . | P Valueb . | Baseline . | Week 24 . | LS Mean Change (SE)a . | P Valueb . | P Valuec . | |
PF | 45.4 (1.5) | 46.8 (1.7) | 1.3 (1.2) | 0.278 | 49.2 (1.0) | 50.1 (1.1) | 1.4 (0.8) | 0.071 | 0.894 |
RP | 46.3 (1.6) | 47.0 (1.6) | −0.9 (1.3) | 0.476 | 47.8 (1.0) | 49.7 (1.0) | 1.2 (0.9) | 0.167 | 0.143 |
BP | 48.1 (1.4) | 47.9 (1.7) | −0.6 (1.4) | 0.662 | 48.3 (1.2) | 50.8 (1.3) | 2.0 (1.0) | 0.042 | 0.106 |
GH | 46.3 (2.0) | 46.6 (2.1) | −0.2 (1.1) | 0.843 | 46.1 (1.3) | 48.5 (1.2) | 2.0 (0.8) | 0.016 | 0.088 |
VT | 47.7 (1.8) | 50.0 (1.9) | 1.6 (1.4) | 0.258 | 49.5 (1.3) | 53.0 (1.1) | 3.7 (1.0) | <0.001 | 0.173 |
SF | 48.1 (1.6) | 48.5 (1.7) | −0.6 (1.4) | 0.677 | 48.8 (1.2) | 50.0 (1.1) | 0.4 (1.0) | 0.695 | 0.541 |
RE | 47.1 (1.8) | 49.0 (1.6) | −0.2 (1.3) | 0.885 | 49.5 (1.1) | 49.9 (1.0) | −0.6 (0.9) | 0.528 | 0.795 |
MH | 48.8 (1.9) | 50.0 (2.0) | −0.3 (1.2) | 0.807 | 50.8 (1.2) | 52.8 (1.1) | 1.2 (0.9) | 0.175 | 0.283 |
PCS | 46.0 (1.3) | 46.3 (1.6) | −0.1 (1.0) | 0.961 | 47.3 (1.1) | 49.3 (1.0) | 2.0 (0.7) | 0.004 | 0.074 |
MCS | 48.9 (1.9) | 50.5 (1.9) | 0.2 (1.2) | 0.892 | 50.4 (1.2) | 51.9 (1.1) | 0.7 (0.8) | 0.427 | 0.704 |
SF-36 Domain . | Placebo (n=39) . | rhPTH(1-84) (n=83) . | rhPTH(1-84) vs Placebo . | ||||||
---|---|---|---|---|---|---|---|---|---|
Baseline . | Week 24 . | LS Mean Change (SE)a . | P Valueb . | Baseline . | Week 24 . | LS Mean Change (SE)a . | P Valueb . | P Valuec . | |
PF | 45.4 (1.5) | 46.8 (1.7) | 1.3 (1.2) | 0.278 | 49.2 (1.0) | 50.1 (1.1) | 1.4 (0.8) | 0.071 | 0.894 |
RP | 46.3 (1.6) | 47.0 (1.6) | −0.9 (1.3) | 0.476 | 47.8 (1.0) | 49.7 (1.0) | 1.2 (0.9) | 0.167 | 0.143 |
BP | 48.1 (1.4) | 47.9 (1.7) | −0.6 (1.4) | 0.662 | 48.3 (1.2) | 50.8 (1.3) | 2.0 (1.0) | 0.042 | 0.106 |
GH | 46.3 (2.0) | 46.6 (2.1) | −0.2 (1.1) | 0.843 | 46.1 (1.3) | 48.5 (1.2) | 2.0 (0.8) | 0.016 | 0.088 |
VT | 47.7 (1.8) | 50.0 (1.9) | 1.6 (1.4) | 0.258 | 49.5 (1.3) | 53.0 (1.1) | 3.7 (1.0) | <0.001 | 0.173 |
SF | 48.1 (1.6) | 48.5 (1.7) | −0.6 (1.4) | 0.677 | 48.8 (1.2) | 50.0 (1.1) | 0.4 (1.0) | 0.695 | 0.541 |
RE | 47.1 (1.8) | 49.0 (1.6) | −0.2 (1.3) | 0.885 | 49.5 (1.1) | 49.9 (1.0) | −0.6 (0.9) | 0.528 | 0.795 |
MH | 48.8 (1.9) | 50.0 (2.0) | −0.3 (1.2) | 0.807 | 50.8 (1.2) | 52.8 (1.1) | 1.2 (0.9) | 0.175 | 0.283 |
PCS | 46.0 (1.3) | 46.3 (1.6) | −0.1 (1.0) | 0.961 | 47.3 (1.1) | 49.3 (1.0) | 2.0 (0.7) | 0.004 | 0.074 |
MCS | 48.9 (1.9) | 50.5 (1.9) | 0.2 (1.2) | 0.892 | 50.4 (1.2) | 51.9 (1.1) | 0.7 (0.8) | 0.427 | 0.704 |
Data given as unadjusted mean (SE) unless otherwise indicated. The analysis used an MMRM. The analyses included the fixed, categorical effects of rhPTH(1-84), treatment, region, sex, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of age, baseline HRQoL score, and the baseline-by-visit interaction. An unstructured covariance structure shared across treatment groups was used to model the within-patient errors. For all domains, normal population has the mean of 50 and a standard deviation of 10.
Abbreviation: RE, role-emotional.
LS mean change is the model-based mean change from baseline to week 24.
Within-treatment–group P value.
Between-treatment–group P value.
SF-36 Domain . | Placebo (n=39) . | rhPTH(1-84) (n=83) . | rhPTH(1-84) vs Placebo . | ||||||
---|---|---|---|---|---|---|---|---|---|
Baseline . | Week 24 . | LS Mean Change (SE)a . | P Valueb . | Baseline . | Week 24 . | LS Mean Change (SE)a . | P Valueb . | P Valuec . | |
PF | 45.4 (1.5) | 46.8 (1.7) | 1.3 (1.2) | 0.278 | 49.2 (1.0) | 50.1 (1.1) | 1.4 (0.8) | 0.071 | 0.894 |
RP | 46.3 (1.6) | 47.0 (1.6) | −0.9 (1.3) | 0.476 | 47.8 (1.0) | 49.7 (1.0) | 1.2 (0.9) | 0.167 | 0.143 |
BP | 48.1 (1.4) | 47.9 (1.7) | −0.6 (1.4) | 0.662 | 48.3 (1.2) | 50.8 (1.3) | 2.0 (1.0) | 0.042 | 0.106 |
GH | 46.3 (2.0) | 46.6 (2.1) | −0.2 (1.1) | 0.843 | 46.1 (1.3) | 48.5 (1.2) | 2.0 (0.8) | 0.016 | 0.088 |
VT | 47.7 (1.8) | 50.0 (1.9) | 1.6 (1.4) | 0.258 | 49.5 (1.3) | 53.0 (1.1) | 3.7 (1.0) | <0.001 | 0.173 |
SF | 48.1 (1.6) | 48.5 (1.7) | −0.6 (1.4) | 0.677 | 48.8 (1.2) | 50.0 (1.1) | 0.4 (1.0) | 0.695 | 0.541 |
RE | 47.1 (1.8) | 49.0 (1.6) | −0.2 (1.3) | 0.885 | 49.5 (1.1) | 49.9 (1.0) | −0.6 (0.9) | 0.528 | 0.795 |
MH | 48.8 (1.9) | 50.0 (2.0) | −0.3 (1.2) | 0.807 | 50.8 (1.2) | 52.8 (1.1) | 1.2 (0.9) | 0.175 | 0.283 |
PCS | 46.0 (1.3) | 46.3 (1.6) | −0.1 (1.0) | 0.961 | 47.3 (1.1) | 49.3 (1.0) | 2.0 (0.7) | 0.004 | 0.074 |
MCS | 48.9 (1.9) | 50.5 (1.9) | 0.2 (1.2) | 0.892 | 50.4 (1.2) | 51.9 (1.1) | 0.7 (0.8) | 0.427 | 0.704 |
SF-36 Domain . | Placebo (n=39) . | rhPTH(1-84) (n=83) . | rhPTH(1-84) vs Placebo . | ||||||
---|---|---|---|---|---|---|---|---|---|
Baseline . | Week 24 . | LS Mean Change (SE)a . | P Valueb . | Baseline . | Week 24 . | LS Mean Change (SE)a . | P Valueb . | P Valuec . | |
PF | 45.4 (1.5) | 46.8 (1.7) | 1.3 (1.2) | 0.278 | 49.2 (1.0) | 50.1 (1.1) | 1.4 (0.8) | 0.071 | 0.894 |
RP | 46.3 (1.6) | 47.0 (1.6) | −0.9 (1.3) | 0.476 | 47.8 (1.0) | 49.7 (1.0) | 1.2 (0.9) | 0.167 | 0.143 |
BP | 48.1 (1.4) | 47.9 (1.7) | −0.6 (1.4) | 0.662 | 48.3 (1.2) | 50.8 (1.3) | 2.0 (1.0) | 0.042 | 0.106 |
GH | 46.3 (2.0) | 46.6 (2.1) | −0.2 (1.1) | 0.843 | 46.1 (1.3) | 48.5 (1.2) | 2.0 (0.8) | 0.016 | 0.088 |
VT | 47.7 (1.8) | 50.0 (1.9) | 1.6 (1.4) | 0.258 | 49.5 (1.3) | 53.0 (1.1) | 3.7 (1.0) | <0.001 | 0.173 |
SF | 48.1 (1.6) | 48.5 (1.7) | −0.6 (1.4) | 0.677 | 48.8 (1.2) | 50.0 (1.1) | 0.4 (1.0) | 0.695 | 0.541 |
RE | 47.1 (1.8) | 49.0 (1.6) | −0.2 (1.3) | 0.885 | 49.5 (1.1) | 49.9 (1.0) | −0.6 (0.9) | 0.528 | 0.795 |
MH | 48.8 (1.9) | 50.0 (2.0) | −0.3 (1.2) | 0.807 | 50.8 (1.2) | 52.8 (1.1) | 1.2 (0.9) | 0.175 | 0.283 |
PCS | 46.0 (1.3) | 46.3 (1.6) | −0.1 (1.0) | 0.961 | 47.3 (1.1) | 49.3 (1.0) | 2.0 (0.7) | 0.004 | 0.074 |
MCS | 48.9 (1.9) | 50.5 (1.9) | 0.2 (1.2) | 0.892 | 50.4 (1.2) | 51.9 (1.1) | 0.7 (0.8) | 0.427 | 0.704 |
Data given as unadjusted mean (SE) unless otherwise indicated. The analysis used an MMRM. The analyses included the fixed, categorical effects of rhPTH(1-84), treatment, region, sex, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of age, baseline HRQoL score, and the baseline-by-visit interaction. An unstructured covariance structure shared across treatment groups was used to model the within-patient errors. For all domains, normal population has the mean of 50 and a standard deviation of 10.
Abbreviation: RE, role-emotional.
LS mean change is the model-based mean change from baseline to week 24.
Within-treatment–group P value.
Between-treatment–group P value.
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