Table 3.

SF-36 Scores at Baseline and After 24 Weeks of Treatment

SF-36 Domain Placebo (n=39) rhPTH(1-84) (n=83)rhPTH(1-84) vs Placebo
BaselineWeek 24LS Mean Change (SE)aP ValuebBaselineWeek 24LS Mean Change (SE)aP ValuebP Valuec
PF45.4 (1.5)46.8 (1.7)1.3 (1.2)0.27849.2 (1.0)50.1 (1.1)1.4 (0.8)0.0710.894
RP46.3 (1.6)47.0 (1.6)−0.9 (1.3)0.47647.8 (1.0)49.7 (1.0)1.2 (0.9)0.1670.143
BP48.1 (1.4)47.9 (1.7)−0.6 (1.4)0.66248.3 (1.2)50.8 (1.3)2.0 (1.0)0.0420.106
GH46.3 (2.0)46.6 (2.1)−0.2 (1.1)0.84346.1 (1.3)48.5 (1.2)2.0 (0.8)0.0160.088
VT47.7 (1.8)50.0 (1.9)1.6 (1.4)0.25849.5 (1.3)53.0 (1.1)3.7 (1.0)<0.0010.173
SF48.1 (1.6)48.5 (1.7)−0.6 (1.4)0.67748.8 (1.2)50.0 (1.1)0.4 (1.0)0.6950.541
RE47.1 (1.8)49.0 (1.6)−0.2 (1.3)0.88549.5 (1.1)49.9 (1.0)−0.6 (0.9)0.5280.795
MH48.8 (1.9)50.0 (2.0)−0.3 (1.2)0.80750.8 (1.2)52.8 (1.1)1.2 (0.9)0.1750.283
PCS46.0 (1.3)46.3 (1.6)−0.1 (1.0)0.96147.3 (1.1)49.3 (1.0)2.0 (0.7)0.0040.074
MCS48.9 (1.9)50.5 (1.9)0.2 (1.2)0.89250.4 (1.2)51.9 (1.1)0.7 (0.8)0.4270.704
SF-36 Domain Placebo (n=39) rhPTH(1-84) (n=83)rhPTH(1-84) vs Placebo
BaselineWeek 24LS Mean Change (SE)aP ValuebBaselineWeek 24LS Mean Change (SE)aP ValuebP Valuec
PF45.4 (1.5)46.8 (1.7)1.3 (1.2)0.27849.2 (1.0)50.1 (1.1)1.4 (0.8)0.0710.894
RP46.3 (1.6)47.0 (1.6)−0.9 (1.3)0.47647.8 (1.0)49.7 (1.0)1.2 (0.9)0.1670.143
BP48.1 (1.4)47.9 (1.7)−0.6 (1.4)0.66248.3 (1.2)50.8 (1.3)2.0 (1.0)0.0420.106
GH46.3 (2.0)46.6 (2.1)−0.2 (1.1)0.84346.1 (1.3)48.5 (1.2)2.0 (0.8)0.0160.088
VT47.7 (1.8)50.0 (1.9)1.6 (1.4)0.25849.5 (1.3)53.0 (1.1)3.7 (1.0)<0.0010.173
SF48.1 (1.6)48.5 (1.7)−0.6 (1.4)0.67748.8 (1.2)50.0 (1.1)0.4 (1.0)0.6950.541
RE47.1 (1.8)49.0 (1.6)−0.2 (1.3)0.88549.5 (1.1)49.9 (1.0)−0.6 (0.9)0.5280.795
MH48.8 (1.9)50.0 (2.0)−0.3 (1.2)0.80750.8 (1.2)52.8 (1.1)1.2 (0.9)0.1750.283
PCS46.0 (1.3)46.3 (1.6)−0.1 (1.0)0.96147.3 (1.1)49.3 (1.0)2.0 (0.7)0.0040.074
MCS48.9 (1.9)50.5 (1.9)0.2 (1.2)0.89250.4 (1.2)51.9 (1.1)0.7 (0.8)0.4270.704

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.

a

LS mean change is the model-based mean change from baseline to week 24.

b

Within-treatment–group P value.

c

Between-treatment–group P value.

Table 3.

SF-36 Scores at Baseline and After 24 Weeks of Treatment

SF-36 Domain Placebo (n=39) rhPTH(1-84) (n=83)rhPTH(1-84) vs Placebo
BaselineWeek 24LS Mean Change (SE)aP ValuebBaselineWeek 24LS Mean Change (SE)aP ValuebP Valuec
PF45.4 (1.5)46.8 (1.7)1.3 (1.2)0.27849.2 (1.0)50.1 (1.1)1.4 (0.8)0.0710.894
RP46.3 (1.6)47.0 (1.6)−0.9 (1.3)0.47647.8 (1.0)49.7 (1.0)1.2 (0.9)0.1670.143
BP48.1 (1.4)47.9 (1.7)−0.6 (1.4)0.66248.3 (1.2)50.8 (1.3)2.0 (1.0)0.0420.106
GH46.3 (2.0)46.6 (2.1)−0.2 (1.1)0.84346.1 (1.3)48.5 (1.2)2.0 (0.8)0.0160.088
VT47.7 (1.8)50.0 (1.9)1.6 (1.4)0.25849.5 (1.3)53.0 (1.1)3.7 (1.0)<0.0010.173
SF48.1 (1.6)48.5 (1.7)−0.6 (1.4)0.67748.8 (1.2)50.0 (1.1)0.4 (1.0)0.6950.541
RE47.1 (1.8)49.0 (1.6)−0.2 (1.3)0.88549.5 (1.1)49.9 (1.0)−0.6 (0.9)0.5280.795
MH48.8 (1.9)50.0 (2.0)−0.3 (1.2)0.80750.8 (1.2)52.8 (1.1)1.2 (0.9)0.1750.283
PCS46.0 (1.3)46.3 (1.6)−0.1 (1.0)0.96147.3 (1.1)49.3 (1.0)2.0 (0.7)0.0040.074
MCS48.9 (1.9)50.5 (1.9)0.2 (1.2)0.89250.4 (1.2)51.9 (1.1)0.7 (0.8)0.4270.704
SF-36 Domain Placebo (n=39) rhPTH(1-84) (n=83)rhPTH(1-84) vs Placebo
BaselineWeek 24LS Mean Change (SE)aP ValuebBaselineWeek 24LS Mean Change (SE)aP ValuebP Valuec
PF45.4 (1.5)46.8 (1.7)1.3 (1.2)0.27849.2 (1.0)50.1 (1.1)1.4 (0.8)0.0710.894
RP46.3 (1.6)47.0 (1.6)−0.9 (1.3)0.47647.8 (1.0)49.7 (1.0)1.2 (0.9)0.1670.143
BP48.1 (1.4)47.9 (1.7)−0.6 (1.4)0.66248.3 (1.2)50.8 (1.3)2.0 (1.0)0.0420.106
GH46.3 (2.0)46.6 (2.1)−0.2 (1.1)0.84346.1 (1.3)48.5 (1.2)2.0 (0.8)0.0160.088
VT47.7 (1.8)50.0 (1.9)1.6 (1.4)0.25849.5 (1.3)53.0 (1.1)3.7 (1.0)<0.0010.173
SF48.1 (1.6)48.5 (1.7)−0.6 (1.4)0.67748.8 (1.2)50.0 (1.1)0.4 (1.0)0.6950.541
RE47.1 (1.8)49.0 (1.6)−0.2 (1.3)0.88549.5 (1.1)49.9 (1.0)−0.6 (0.9)0.5280.795
MH48.8 (1.9)50.0 (2.0)−0.3 (1.2)0.80750.8 (1.2)52.8 (1.1)1.2 (0.9)0.1750.283
PCS46.0 (1.3)46.3 (1.6)−0.1 (1.0)0.96147.3 (1.1)49.3 (1.0)2.0 (0.7)0.0040.074
MCS48.9 (1.9)50.5 (1.9)0.2 (1.2)0.89250.4 (1.2)51.9 (1.1)0.7 (0.8)0.4270.704

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.

a

LS mean change is the model-based mean change from baseline to week 24.

b

Within-treatment–group P value.

c

Between-treatment–group P value.

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