Effects of ospemifene on bone in postmenopausal women

Figures & data

Figure 1. LS mean changes from baseline for bone resorption markers with ospemifene versus placebo at week 12. ^ap < 0.05; ^bp < 0.001; ^cp < 0.0001. CTX, C-terminal cross-linking telopeptides of type I collagen; DPD, deoxypyridinoline; LS, least-squares; NTX, N-terminal cross-linking telopeptides of type I collagen; TRACP-5b, tartrate-resistant acid phosphatase 5b.

Figure 2. LS mean changes from baseline for bone formation markers with ospemifene versus placebo at week 12. ^ap < 0.01; ^bp < 0.0001. ALP, serum total alkaline phosphatase; BS-ALP, bone specific serum total alkaline phosphatase; LS, least-squares; OLC, osteocalcin; PINP, procollagen type I N-terminal propeptide.

Table 1. Changes at week 12 in markers of bone resorption with ospemifene versus placebo^a.

Marker	Ospemifene 60 mg (n = 313)	Placebo (n = 314)	Difference of LS, mean (95% CI)	p-Value
BSP (pg/ml)
Baseline
n	304	312
Mean (SD)	39,014.6 (201,567.4)	31,722.8 (158,379.3)
Change, BL to week 12
n	264	271
LS mean (SE)	–24,964.3 (3922.5)	–20,576.1 (3871.5)	–4388.3 (–15,214.8, 6438.3)	0.4263
CTX (ng/ml)
Baseline
n	301	303
Mean (SD)	0.428 (0.221)	0.438 (0.219)
Change, BL to week 12
n	261	260
LS mean (SE)	–0.044 (0.008)	0.006 (0.008)	–0.049 (–0.071, –0.027)	<0.0001
DPD (μmol/mol)
Baseline
n	304	310
Mean (SD)	6.75 (2.34)	6.96 (2.47)
Change, BL to week 12
n	261	260
LS mean (SE)	0.08 (0.16)	0.22 (0.16)	–0.14 (–0.58, 0.29)	0.5159
NTX (nmolBCE/l)
Baseline
n	304	311
Mean (SD)	14.46 (4.81)	14.50 (5.27)
Change, BL to week 12
n	265	270
LS mean (SE)	–0.10 (0.23)	0.65 (0.23)	–0.75 (–1.39, –0.10)	0.0227
TRACP-5b (U/l)
Baseline
n	304	312
Mean (SD)	3.41 (1.36)	3.54 (1.46)
Change, BL to week 12
n	265	270
LS mean (SE)	–0.28 (0.04)	–0.06 (0.04)	–0.22 (–0.34, –0.10)	0.0003

BL, baseline; BSP, bone sialoprotein; CI, confidence interval; CTX, C-terminal cross-linking telopeptides of type I collagen; DPD, deoxypyridinoline; LS, least-squares; NTX, N-terminal cross-linking telopeptides of type I collagen; SD, standard deviation; SE, standard error; TRACP-5b, tartrate-resistant acid phosphatase 5b; BCE, bone collagen equivalent.

^a To calculate LS means, SE, 95% CI, and p-value, an analysis of covariance (ANCOVA) model was used. The ANCOVA model has terms for the treatment group as a fixed effect and the baseline value as a covariate.

Table 2. Changes at week 12 in markers of bone formation with ospemifene versus placebo^a.

Marker	Ospemifene 60 mg (n = 313)	Placebo (n = 314)	Difference of LS, mean (95% CI)	p-Value
ALP (U/l)
Baseline
n	312	314
Mean (SD)	81.9 (21.0)	83.2 (23.9)
Change, BL to week 12
n	258	261
LS mean (SE)	–4.6 (0.7)	1.6 (0.7)	–6.2 (–8.1, –4.3)	<0.0001
Bone-specific ALP (U/l)
Baseline
n	304	311
Mean (SD)	24.92 (8.27)	24.57 (8.24)
Change, BL to week 12
n	265	270
LS mean (SE)	–0.50 (0.36)	0.84 (0.36)	–1.35 (–2.35, –0.35)	0.0084
Osteocalcin (ng/ml)
Baseline
n	304	312
Mean (SD)	23.60 (10.54)	23.58 (9.45)
Change, BL to week 12
n	265	270
LS mean (SE)	–1.43 (0.31)	0.62 (0.31)	–2.06 (–2.92, –1.19)	<0.0001
PINP (ng/ml)
Baseline
n	301	303
Mean (SD)	49.36 (20.60)	50.09 (21.10)
Change, BL to week 12
n	261	260
LS mean (SE)	–3.22 (0.85)	2.04 (0.86)	–5.26 (–7.64, –2.89)	<0.0001

ALP, serum total alkaline phosphatase; BL, baseline; CI, confidence interval; LS, least-squares; PINP, procollagen type I N-terminal propeptide; SD, standard deviation; SE, standard error.

^a To calculate LS means, SE, 95% CI, and p-value, an analysis of covariance (ANCOVA) model was used. The ANCOVA model has terms for the treatment group as a fixed effect and the baseline value as a covariate.