Table 4. Open in new tab Regional SF-36...

SF-36 Domain	North America/Western Europe
PF	46.4 (1.9)	46.8 (2.0)	0.9 (1.2)	0.461	49.2 (1.2)	51.4 (1.1)	3.0 (0.8)	<0.001	0.120
RP	47.8 (1.9)	47.5 (1.8)	−1.3 (1.3)	0.349	47.6 (1.2)	50.5 (1.1)	2.1 (0.9)	0.018	0.030
BP	48.1 (1.5)	47.7 (1.9)	−0.7 (1.5)	0.633	47.9 (1.3)	51.0 (1.3)	2.6 (1.0)	0.013	0.064
GH	47.7 (2.3)	48.6 (2.3)	0.5 (1.2)	0.675	46.3 (1.5)	49.0 (1.4)	2.1 (0.9)	0.016	0.282
VT	48.5 (2.1)	49.2 (2.2)	0.6 (1.4)	0.667	47.7 (1.5)	52.8 (1.2)	4.8 (1.0)	<0.001	0.013
SF	48.5 (1.8)	48.7 (1.9)	−0.4 (1.6)	0.784	48.2 (1.4)	50.2 (1.3)	1.2 (1.1)	0.255	0.364
RE	48.1 (2.0)	49.9 (1.7)	0.2 (1.3)	0.903	50.0 (1.2)	51.1 (1.0)	0.6 (0.9)	0.460	0.743
MH	49.5 (2.0)	50.6 (2.0)	−0.0 (1.3)	0.988	50.1 (1.4)	53.1 (1.2)	2.2 (0.9)	0.017	0.147
PCS	46.9 (1.6)	46.6 (2.0)	−0.5 (1.1)	0.640	47.2 (1.3)	50.0 (1.1)	2.7 (0.7)	<0.001	0.010
MCS	49.5 (2.1)	51.0 (1.9)	0.5 (1.3)	0.723	49.8 (1.4)	52.2 (1.2)	1.7 (0.9)	0.057	0.404

SF-36 Domain

North America/Western Europe

Placebo (n = 32)

rhPTH(1-84) (n = 67)

rhPTH(1-84) vs Placebo

Baseline

Week 24

LS Mean Change (SE)^a

P Value^b

Baseline

Week 24

LS Mean Change (SE)^a

P Value^b

P Value^c

46.4 (1.9)

46.8 (2.0)

0.9 (1.2)

0.461

49.2 (1.2)

51.4 (1.1)

3.0 (0.8)

<0.001

0.120

47.8 (1.9)

47.5 (1.8)

−1.3 (1.3)

0.349

47.6 (1.2)

50.5 (1.1)

2.1 (0.9)

0.018

0.030

48.1 (1.5)

47.7 (1.9)

−0.7 (1.5)

0.633

47.9 (1.3)

51.0 (1.3)

2.6 (1.0)

0.013

0.064

47.7 (2.3)

48.6 (2.3)

0.5 (1.2)

0.675

46.3 (1.5)

49.0 (1.4)

2.1 (0.9)

0.016

0.282

48.5 (2.1)

49.2 (2.2)

0.6 (1.4)

0.667

47.7 (1.5)

52.8 (1.2)

4.8 (1.0)

<0.001

0.013

48.5 (1.8)

48.7 (1.9)

−0.4 (1.6)

0.784

48.2 (1.4)

50.2 (1.3)

1.2 (1.1)

0.255

0.364

48.1 (2.0)

49.9 (1.7)

0.2 (1.3)

0.903

50.0 (1.2)

51.1 (1.0)

0.6 (0.9)

0.460

0.743

49.5 (2.0)

50.6 (2.0)

−0.0 (1.3)

0.988

50.1 (1.4)

53.1 (1.2)

2.2 (0.9)

0.017

0.147

PCS

46.9 (1.6)

46.6 (2.0)

−0.5 (1.1)

0.640

47.2 (1.3)

50.0 (1.1)

2.7 (0.7)

<0.001

0.010

MCS

49.5 (2.1)

51.0 (1.9)

0.5 (1.3)

0.723

49.8 (1.4)

52.2 (1.2)

1.7 (0.9)

0.057

0.404

SF-36 Domain	North America/Western Europe
PF	46.4 (1.9)	46.8 (2.0)	0.9 (1.2)	0.461	49.2 (1.2)	51.4 (1.1)	3.0 (0.8)	<0.001	0.120
RP	47.8 (1.9)	47.5 (1.8)	−1.3 (1.3)	0.349	47.6 (1.2)	50.5 (1.1)	2.1 (0.9)	0.018	0.030
BP	48.1 (1.5)	47.7 (1.9)	−0.7 (1.5)	0.633	47.9 (1.3)	51.0 (1.3)	2.6 (1.0)	0.013	0.064
GH	47.7 (2.3)	48.6 (2.3)	0.5 (1.2)	0.675	46.3 (1.5)	49.0 (1.4)	2.1 (0.9)	0.016	0.282
VT	48.5 (2.1)	49.2 (2.2)	0.6 (1.4)	0.667	47.7 (1.5)	52.8 (1.2)	4.8 (1.0)	<0.001	0.013
SF	48.5 (1.8)	48.7 (1.9)	−0.4 (1.6)	0.784	48.2 (1.4)	50.2 (1.3)	1.2 (1.1)	0.255	0.364
RE	48.1 (2.0)	49.9 (1.7)	0.2 (1.3)	0.903	50.0 (1.2)	51.1 (1.0)	0.6 (0.9)	0.460	0.743
MH	49.5 (2.0)	50.6 (2.0)	−0.0 (1.3)	0.988	50.1 (1.4)	53.1 (1.2)	2.2 (0.9)	0.017	0.147
PCS	46.9 (1.6)	46.6 (2.0)	−0.5 (1.1)	0.640	47.2 (1.3)	50.0 (1.1)	2.7 (0.7)	<0.001	0.010
MCS	49.5 (2.1)	51.0 (1.9)	0.5 (1.3)	0.723	49.8 (1.4)	52.2 (1.2)	1.7 (0.9)	0.057	0.404

	Hungary
PF	42.1 (1.7)	46.9 (2.3)	4.5 (3.3)	0.183	49.4 (1.9)	45.3 (2.6)	−2.8 (2.3)	0.244	0.065
RP	40.8 (2.4)	45.3 (4.1)	2.6 (3.1)	0.411	48.5 (2.5)	46.7 (2.4)	−2.6 (2.4)	0.290	0.157
BP	48.1 (4.1)	48.3 (4.0)	0.1 (4.3)	0.973	49.7 (3.0)	50.1 (3.4)	0.6 (3.3)	0.848	0.914
GH	41.1 (3.6)	39.1 (4.2)	−2.7 (2.7)	0.323	45.3 (2.7)	46.6 (2.6)	1.2 (2.0)	0.570	0.187
VT	45.0 (4.0)	53.0 (3.5)	6.4 (3.5)	0.088	55.9 (2.5)	53.8 (2.7)	−0.6 (2.6)	0.813	0.103
SF	46.6 (4.0)	48.0 (4.0)	1.1 (3.3)	0.752	51.1 (2.1)	48.9 (2.7)	−1.7 (2.4)	0.472	0.464
RE	43.2 (4.1)	45.7 (4.7)	−0.2 (3.6)	0.956	47.7 (3.0)	45.5 (2.9)	−4.0 (2.7)	0.151	0.345
MH	46.4 (5.1)	47.9 (5.9)	1.5 (2.2)	0.504	53.3 (2.3)	51.5 (2.6)	−2.2 (1.7)	0.223	0.148
PCS	42.5 (1.5)	45.2 (2.3)	2.6 (2.7)	0.345	47.8 (2.2)	46.7 (2.5)	−0.1 (2.1)	0.976	0.378
MCS	46.5 (5.1)	48.9 (5.5)	0.1 (3.1)	0.964	52.7 (2.4)	50.9 (2.7)	−4.1 (2.2)	0.085	0.254

Hungary

Placebo (n = 7)

rhPTH(1-84) (n = 16)

42.1 (1.7)

46.9 (2.3)

4.5 (3.3)

0.183

49.4 (1.9)

45.3 (2.6)

−2.8 (2.3)

0.244

0.065

40.8 (2.4)

45.3 (4.1)

2.6 (3.1)

0.411

48.5 (2.5)

46.7 (2.4)

−2.6 (2.4)

0.290

0.157

48.1 (4.1)

48.3 (4.0)

0.1 (4.3)

0.973

49.7 (3.0)

50.1 (3.4)

0.6 (3.3)

0.848

0.914

41.1 (3.6)

39.1 (4.2)

−2.7 (2.7)

0.323

45.3 (2.7)

46.6 (2.6)

1.2 (2.0)

0.570

0.187

45.0 (4.0)

53.0 (3.5)

6.4 (3.5)

0.088

55.9 (2.5)

53.8 (2.7)

−0.6 (2.6)

0.813

0.103

46.6 (4.0)

48.0 (4.0)

1.1 (3.3)

0.752

51.1 (2.1)

48.9 (2.7)

−1.7 (2.4)

0.472

0.464

43.2 (4.1)

45.7 (4.7)

−0.2 (3.6)

0.956

47.7 (3.0)

45.5 (2.9)

−4.0 (2.7)

0.151

0.345

46.4 (5.1)

47.9 (5.9)

1.5 (2.2)

0.504

53.3 (2.3)

51.5 (2.6)

−2.2 (1.7)

0.223

0.148

PCS

42.5 (1.5)

45.2 (2.3)

2.6 (2.7)

0.345

47.8 (2.2)

46.7 (2.5)

−0.1 (2.1)

0.976

0.378

MCS

46.5 (5.1)

48.9 (5.5)

0.1 (3.1)

0.964

52.7 (2.4)

50.9 (2.7)

−4.1 (2.2)

0.085

0.254

	Hungary
PF	42.1 (1.7)	46.9 (2.3)	4.5 (3.3)	0.183	49.4 (1.9)	45.3 (2.6)	−2.8 (2.3)	0.244	0.065
RP	40.8 (2.4)	45.3 (4.1)	2.6 (3.1)	0.411	48.5 (2.5)	46.7 (2.4)	−2.6 (2.4)	0.290	0.157
BP	48.1 (4.1)	48.3 (4.0)	0.1 (4.3)	0.973	49.7 (3.0)	50.1 (3.4)	0.6 (3.3)	0.848	0.914
GH	41.1 (3.6)	39.1 (4.2)	−2.7 (2.7)	0.323	45.3 (2.7)	46.6 (2.6)	1.2 (2.0)	0.570	0.187
VT	45.0 (4.0)	53.0 (3.5)	6.4 (3.5)	0.088	55.9 (2.5)	53.8 (2.7)	−0.6 (2.6)	0.813	0.103
SF	46.6 (4.0)	48.0 (4.0)	1.1 (3.3)	0.752	51.1 (2.1)	48.9 (2.7)	−1.7 (2.4)	0.472	0.464
RE	43.2 (4.1)	45.7 (4.7)	−0.2 (3.6)	0.956	47.7 (3.0)	45.5 (2.9)	−4.0 (2.7)	0.151	0.345
MH	46.4 (5.1)	47.9 (5.9)	1.5 (2.2)	0.504	53.3 (2.3)	51.5 (2.6)	−2.2 (1.7)	0.223	0.148
PCS	42.5 (1.5)	45.2 (2.3)	2.6 (2.7)	0.345	47.8 (2.2)	46.7 (2.5)	−0.1 (2.1)	0.976	0.378
MCS	46.5 (5.1)	48.9 (5.5)	0.1 (3.1)	0.964	52.7 (2.4)	50.9 (2.7)	−4.1 (2.2)	0.085	0.254

Table 4.

Open in new tab

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

SF-36 Domain	North America/Western Europe
	Placebo (n = 32)				rhPTH(1-84) (n = 67)				rhPTH(1-84) vs Placebo
	Baseline	Week 24	LS Mean Change (SE)^a	P Value^b	Baseline	Week 24	LS Mean Change (SE)^a	P Value^b	P Value^c
PF	46.4 (1.9)	46.8 (2.0)	0.9 (1.2)	0.461	49.2 (1.2)	51.4 (1.1)	3.0 (0.8)	<0.001	0.120
RP	47.8 (1.9)	47.5 (1.8)	−1.3 (1.3)	0.349	47.6 (1.2)	50.5 (1.1)	2.1 (0.9)	0.018	0.030
BP	48.1 (1.5)	47.7 (1.9)	−0.7 (1.5)	0.633	47.9 (1.3)	51.0 (1.3)	2.6 (1.0)	0.013	0.064
GH	47.7 (2.3)	48.6 (2.3)	0.5 (1.2)	0.675	46.3 (1.5)	49.0 (1.4)	2.1 (0.9)	0.016	0.282
VT	48.5 (2.1)	49.2 (2.2)	0.6 (1.4)	0.667	47.7 (1.5)	52.8 (1.2)	4.8 (1.0)	<0.001	0.013
SF	48.5 (1.8)	48.7 (1.9)	−0.4 (1.6)	0.784	48.2 (1.4)	50.2 (1.3)	1.2 (1.1)	0.255	0.364
RE	48.1 (2.0)	49.9 (1.7)	0.2 (1.3)	0.903	50.0 (1.2)	51.1 (1.0)	0.6 (0.9)	0.460	0.743
MH	49.5 (2.0)	50.6 (2.0)	−0.0 (1.3)	0.988	50.1 (1.4)	53.1 (1.2)	2.2 (0.9)	0.017	0.147
PCS	46.9 (1.6)	46.6 (2.0)	−0.5 (1.1)	0.640	47.2 (1.3)	50.0 (1.1)	2.7 (0.7)	<0.001	0.010
MCS	49.5 (2.1)	51.0 (1.9)	0.5 (1.3)	0.723	49.8 (1.4)	52.2 (1.2)	1.7 (0.9)	0.057	0.404

SF-36 Domain	North America/Western Europe
	Placebo (n = 32)				rhPTH(1-84) (n = 67)				rhPTH(1-84) vs Placebo
	Baseline	Week 24	LS Mean Change (SE)^a	P Value^b	Baseline	Week 24	LS Mean Change (SE)^a	P Value^b	P Value^c
PF	46.4 (1.9)	46.8 (2.0)	0.9 (1.2)	0.461	49.2 (1.2)	51.4 (1.1)	3.0 (0.8)	<0.001	0.120
RP	47.8 (1.9)	47.5 (1.8)	−1.3 (1.3)	0.349	47.6 (1.2)	50.5 (1.1)	2.1 (0.9)	0.018	0.030
BP	48.1 (1.5)	47.7 (1.9)	−0.7 (1.5)	0.633	47.9 (1.3)	51.0 (1.3)	2.6 (1.0)	0.013	0.064
GH	47.7 (2.3)	48.6 (2.3)	0.5 (1.2)	0.675	46.3 (1.5)	49.0 (1.4)	2.1 (0.9)	0.016	0.282
VT	48.5 (2.1)	49.2 (2.2)	0.6 (1.4)	0.667	47.7 (1.5)	52.8 (1.2)	4.8 (1.0)	<0.001	0.013
SF	48.5 (1.8)	48.7 (1.9)	−0.4 (1.6)	0.784	48.2 (1.4)	50.2 (1.3)	1.2 (1.1)	0.255	0.364
RE	48.1 (2.0)	49.9 (1.7)	0.2 (1.3)	0.903	50.0 (1.2)	51.1 (1.0)	0.6 (0.9)	0.460	0.743
MH	49.5 (2.0)	50.6 (2.0)	−0.0 (1.3)	0.988	50.1 (1.4)	53.1 (1.2)	2.2 (0.9)	0.017	0.147
PCS	46.9 (1.6)	46.6 (2.0)	−0.5 (1.1)	0.640	47.2 (1.3)	50.0 (1.1)	2.7 (0.7)	<0.001	0.010
MCS	49.5 (2.1)	51.0 (1.9)	0.5 (1.3)	0.723	49.8 (1.4)	52.2 (1.2)	1.7 (0.9)	0.057	0.404

	Hungary
	Placebo (n = 7)				rhPTH(1-84) (n = 16)
PF	42.1 (1.7)	46.9 (2.3)	4.5 (3.3)	0.183	49.4 (1.9)	45.3 (2.6)	−2.8 (2.3)	0.244	0.065
RP	40.8 (2.4)	45.3 (4.1)	2.6 (3.1)	0.411	48.5 (2.5)	46.7 (2.4)	−2.6 (2.4)	0.290	0.157
BP	48.1 (4.1)	48.3 (4.0)	0.1 (4.3)	0.973	49.7 (3.0)	50.1 (3.4)	0.6 (3.3)	0.848	0.914
GH	41.1 (3.6)	39.1 (4.2)	−2.7 (2.7)	0.323	45.3 (2.7)	46.6 (2.6)	1.2 (2.0)	0.570	0.187
VT	45.0 (4.0)	53.0 (3.5)	6.4 (3.5)	0.088	55.9 (2.5)	53.8 (2.7)	−0.6 (2.6)	0.813	0.103
SF	46.6 (4.0)	48.0 (4.0)	1.1 (3.3)	0.752	51.1 (2.1)	48.9 (2.7)	−1.7 (2.4)	0.472	0.464
RE	43.2 (4.1)	45.7 (4.7)	−0.2 (3.6)	0.956	47.7 (3.0)	45.5 (2.9)	−4.0 (2.7)	0.151	0.345
MH	46.4 (5.1)	47.9 (5.9)	1.5 (2.2)	0.504	53.3 (2.3)	51.5 (2.6)	−2.2 (1.7)	0.223	0.148
PCS	42.5 (1.5)	45.2 (2.3)	2.6 (2.7)	0.345	47.8 (2.2)	46.7 (2.5)	−0.1 (2.1)	0.976	0.378
MCS	46.5 (5.1)	48.9 (5.5)	0.1 (3.1)	0.964	52.7 (2.4)	50.9 (2.7)	−4.1 (2.2)	0.085	0.254

	Hungary
	Placebo (n = 7)				rhPTH(1-84) (n = 16)
PF	42.1 (1.7)	46.9 (2.3)	4.5 (3.3)	0.183	49.4 (1.9)	45.3 (2.6)	−2.8 (2.3)	0.244	0.065
RP	40.8 (2.4)	45.3 (4.1)	2.6 (3.1)	0.411	48.5 (2.5)	46.7 (2.4)	−2.6 (2.4)	0.290	0.157
BP	48.1 (4.1)	48.3 (4.0)	0.1 (4.3)	0.973	49.7 (3.0)	50.1 (3.4)	0.6 (3.3)	0.848	0.914
GH	41.1 (3.6)	39.1 (4.2)	−2.7 (2.7)	0.323	45.3 (2.7)	46.6 (2.6)	1.2 (2.0)	0.570	0.187
VT	45.0 (4.0)	53.0 (3.5)	6.4 (3.5)	0.088	55.9 (2.5)	53.8 (2.7)	−0.6 (2.6)	0.813	0.103
SF	46.6 (4.0)	48.0 (4.0)	1.1 (3.3)	0.752	51.1 (2.1)	48.9 (2.7)	−1.7 (2.4)	0.472	0.464
RE	43.2 (4.1)	45.7 (4.7)	−0.2 (3.6)	0.956	47.7 (3.0)	45.5 (2.9)	−4.0 (2.7)	0.151	0.345
MH	46.4 (5.1)	47.9 (5.9)	1.5 (2.2)	0.504	53.3 (2.3)	51.5 (2.6)	−2.2 (1.7)	0.223	0.148
PCS	42.5 (1.5)	45.2 (2.3)	2.6 (2.7)	0.345	47.8 (2.2)	46.7 (2.5)	−0.1 (2.1)	0.976	0.378
MCS	46.5 (5.1)	48.9 (5.5)	0.1 (3.1)	0.964	52.7 (2.4)	50.9 (2.7)	−4.1 (2.2)	0.085	0.254

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, 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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