Early changes in 25-hydroxyvitamin D levels and bone markers after monthly risedronate with cholecalciferol in Korean patients with osteoporosis

Figures & data

Table 1 Baseline characteristics of the participants

	RSDM+ (n = 74), n (%)	RSDM (n = 76), n (%)	P-value
Age (mean ± SD)	65.1 ± 6.8	65.7 ± 8.3	0.646
Alcohol			0.438
Yes	4 (5.4)	2 (2.6)
No	70 (94.6)	74 (97.4)
Smoking
No	74 (100)	76 (100)	–
BMI (kg/m^2)	23.8 ± 2.2	24.6 ± 3.0	0.055
25(OH)D (ng/mL)	17.8 ± 6.6	18.1 ± 7.6	0.755
25(OH)D
<20 ng/mL	57 (77%)	53 (69.7%)	0.118
<30 ng/mL	11 (14.9%)	13 (17.1%)	0.426
≥30 ng/mL	6 (8.1%)	10 (13.2%)	0.320
PTH (pg/mL)	46.0 ± 18.6	38.0 ± 13.7	0.003
BSAP (U/L)	32.6 ± 9.8	31.5 ± 10.8	0.551
CTX (ng/mL)	0.42 ± 0.21	0.41 ± 0.24	0.838

Abbreviations: RSDM+, monthly risedronate and cholecalciferol; RSDM, monthly risedronate alone; SD, standard deviation; BMI, body mass index; 25(OH)D, 25-hydroxyvitamin D; PTH, parathyroid hormone; BSAP, bone-specific alkaline phosphatase; CTX, carboxy-terminal collagen cross-links.

Figure 1 Participant disposition in 16-week study.

Note: Randomization and follow-up study.

Figure 2 Mean changes in serum 25-hydroxyvitamin D (25[OH]D) concentration after 16 weeks of treatment.

Abbreviations: RSDM+, monthly risedronate and cholecalciferol; RSDM, monthly risedronate alone.

Figure 3 Percentages of participants with 25-hydroxyvitamin D level in different subcategories at week 16.

Abbreviations: RSDM+, monthly risedronate and cholecalciferol; RSDM, monthly risedronate alone.

Figure 4 Mean changes in 25-hydroxyvitamin D (25[OH]D) level in each group with different baseline subcategories.

Abbreviations: RSDM+, monthly risedronate and cholecalciferol; RSDM, monthly risedronate alone.

Table 2 Changes in PTH, calcium, phosphorus, and bone turnover markers between baseline and week 16 of treatment

	Mean ± SD		P-value*
	RSDM+	RSDM
PTH (pg/mL)
Baseline	46.0 ± 18.63	38.0 ± 13.72	0.003
Week 16	36.7 ± 18.55	40.6 ± 16.9
Change	−9.06 ± 20.32	2.15 ± 17.52	0.0007***
P-value**	0.0005	0.3091
Calcium (mg/dL)
Baseline	8.96 ± 0.37	9.08 ± 0.41	0.0471
Week 16	8.92 ± 0.43	8.9 ± 0.47
Change	−0.02 ± 0.34	−0.18 ± 0.48	0.0317***
P-value**	0.6427	0.0036
Phosphorus (mg/dL)
Baseline	3.74 ± 0.41	3.82 ± 0.47	0.2501
Week 16	3.56 ± 0.45	3.65 ± 0.44
Change	−0.19 ± 0.47	−0.19 ± 0.51	0.9553
P-value**	0.0018	0.0029
BSAP (U/L)
Baseline	32.5 ± 9.83	31.5 ± 10.78	0.5513
Week 16	18.3 ± 4.6	19.1 ± 5.15
Change	−14.2 ± 8.07	−12.2 ± 9.67	0.1891
P-value**	<0.0001	<0.0001
CTX (ng/mL)
Baseline	0.42 ± 0.21	0.41 ± 0.24	0.8381
Week 16	0.13 ± 0.10	0.16 ± 0.11
Change	−0.32 ± 0.25	−0.31 ± 0.20	0.2735
P-value**	<0.0001	<0.0001

Notes:

* Unpaired t-test;

** paired t-test;

*** analysis of covariance.

Abbreviations: RSDM+, monthly risedronate and cholecalciferol; RSDM, monthly risedronate alone; SD, standard deviation; PTH, parathyroid hormone; BSAP, bone-specific alkaline phosphatase; CTX, carboxy-terminal collagen cross-links.