The effectiveness of teriparatide in the clinical practice—attenuation of the bone mineral density outcome by increasing age and bisphosphonate pretreatment

Figures & data

Figure 1. The criteria of the Social Insurance Institution of Finland for the reimbursement of teriparatide at the time of the study.

Table I. Baseline characteristics (mean ± SD, or median (range)) for the whole study population and Orton and non-Orton-subpopulations separately.

	Total population (n = 119)	Orton (n = 68)	non-Orton (n = 51)	P
Age, years	67.7 ± 12.9	72.2 ± 11.5	61.7 ± 12.4	P <0.0001
Weight, kg	59.2 ± 10.8	59.6 ± 9.5	58.6 ± 12.4	P = 0.60
Height, cm	159.1 ± 8.2	158.8 ± 8.0	159.4 ± 8.6	P = 0.73
Gender, female/male	113/6	66/2	47/4	P = 0.40
Vitamin D intake, IU/d	600 (0–1600)	600 (0–800)	800 (0–1600)	P = 0.014
Calcium intake, mg/d	750 (0–1600)	750 (0–1000)	1000 (0–1600)	P = 0.014
Duration of teriparatide treatment (days)	539 (179–926)	547 (179–755)	532 (364–926)	P = 0.054
Duration of bisphosphonate pretreatment (days)	848 (2–5258)	772 (2–5258)	1037 (7–4001)	P = 0.090
Bisphosphonate lag time (days)^a	0 (0–381)	0 (0–160)	0 (0–381)	P <0.0001
Plasma-AFOS, U/L (n = 34)			76 (29–242)
Serum-P1NP, μg/L (n = 12)			24.6 (13.2–53.7)
Urinary NTx, nmol/mmol creatinine (n = 13)			26 (12–117)
T score total hip	–2.3 ± 1.0	–2.3 ± 0.8	–2.4 ± 1.2	P = 0.44
T score femoral neck	–2.5 ± 0.8	–2.3 ± 0.8	–2.6 ± 0.8	P = 0.040
T score L1–L4	–2.45 ± 1.6	–2.0 ± 1.4	–3.0 ± 1.6	P = 0.0008
Vertebral fractures, number of patients				P = 0.21
no vertebral fractures	37 (31%)	23 (34%)	14 (27%)
1 fracture	18 (15%)	11 (16%)	7 (14%)
≥ 2 fractures	64 (54%)	34 (50%)	30 (59%)

P for differences between the subpopulations.

^aTime from stopping bisphosphonates to starting teriparatide.

Table II. Baseline BMD and its changes during teriparatide in the whole study population and in the Orton- and non-Orton subpopulations separately.

Mean (SD)	Total population (n = 119)	Orton (n = 68)	Non-Orton (n = 51)	P
Baseline BMD (g/cm^2)
Femoral neck BMD	0.658 (0.111)	0.696 (0.097)	0.609 (0.109)	P <0.0001
Total hip BMD	0.718 (0.117)	0.735 (0.103)	0.693 (0.132)	P = 0.070
Lumbar spine (L1–L4) BMD	0.858 (0.202)	0.926 (0.173)	0.760 (0.202)	P <0.0001
Change in BMD (%)
Femoral neck, g/cm^2	2.1 (7.4)	3.0 (6.3)	0.9 (8.6)
Total hip, g/cm^2	0.9 (7.2)	1.9 (4.1)	–0.3 (9.8)
L1–L4, g/cm^2	8.5 (9.0)	8.6 (6.8)	8.3 (11.5)
Baseline adjusted change in BMD (%)
Mean (SE)
Femoral neck, g/cm^2		3.6 (1.0)	0.1 (1.1)	P = 0.022
Total hip, g/cm^2		2.2 (0.9)	–0.7 (1.1)	P = 0.041
L1–L4, g/cm^2		9.7 (1.1)	6.8 (1.4)	P = 0.11

P for differences between the subpopulations.

n = number of patients at baseline.

Table III. Results of statistical analysis to explain teriparatide-induced BMD changes. The depicted analyses of age, weight, number of fractures, on-going glucocorticoid treatment, and any significant bisphosphonate treatment are associations to BMD levels. The impact of age and any significant bisphosphonate treatment are also shown as determinants of BMD changes during the teriparatide treatment.

	Total hip BMD	Neck BMD	Lumbar spine BMD
Age	P = 0.24	P = 0.50	P <0.0001
Treatment effect ( = time effect, change over time)	P = 0.0075	P = 0.0006	P = 0.0085
Age × Treatment	P = 0.019	P = 0.0036	P = 0.48
Weight	P <0.0001	P <0.0001	P = 0.0003
Number of fractures	P = 0.50	P = 0.46	P = 0.74
On-going glucocorticoid treatment	P = 0.96	P = 0.65	P = 0.75
Any significant bisphosphonate treatment	P = 0.0090	P = 0.0002	P = 0.40
Any significant bisphosphonate treatment × Treatment	P = 0.039	P = 0.28	P = 0.091

Table IV. The effect of any significant bisphosphonate pretreatment on baseline BMD levels and their changes during teriparatide treatment (mean (SE)).

		Total hip		Femoral neck		Lumbar spine (L1–L4)
	n	Baseline (g/cm^2)	% Change	Baseline (g/cm^2)	% Change	Baseline (g/cm^2)	% Change
No significant bisphosphonate pretreatment	29	0.742 (0.020)	2.6 (0.8)	0.717 (0.019)	2.8 (1.1)	0.826 (0.033)	11.5 (1.4)
Significant bisphosphonate pretreatment	90	0.710 (0.014)	0.4 (0.9)	0.639 (0.012)	1.8 (0.9)	0.869 (0.023)	7.4 (1.1)