Three-year experience with combined treatment with alendronate and alfacalcidol in Japanese patients with severe bone loss and osteoporotic fracture

Figures & data

Table 1 Characteristics of study subjects at the start of treatment

Characteristic	Value
Gender (male/female)	6/28
Age (years)	67.4 ± 9.5 (41–80)
Height (m)	1.50 ± 0.10 (1.31–1.77)
Body weight (kg)	45.8 ± 8.8 (35–68)
Body mass index (kg/m^2)	20.3 ± 2.2 (16.8–26.7)
Lumbar spine BMD (g/cm^2)	0.464 ± 0.042 (0.323–0.511)
%YAM of lumbar spine BMD (%)	45.8 ± 4.0 (33–50)
Total hip BMD (g/cm^2)	0.395 ± 0.071 (0.293–0.450)
%YAM of total hip BMD (%)	43.8 ± 5.2 (36–47)
Serum calcium (mg/dL)	9.4 ± 0.4 (8.7–10.2)
Serum phosphorus (mg/dL)	3.2 ± 0.4 (2.4–4.0)
Serum ALP (IU/L)	297 ± 113 (133–532)
Urinary NTX (nmol BCE/mmol Cr)	84.9 ± 39.4 (42.8–205.3)
Number (%) of patients with prevalent vertebral fractures	30 (88.2%)
Number (%) of patients with history of non-vertebral fractures	6 (17.6%)

Notes: Data are expressed as means ± SD. Numbers in the parenthesis of the right column are ranges.

Abbreviations: BMD, bone mineral density; YAM, young adult mean; ALP, alkaline phosphatase; NTX, cross linked N-terminal telopeptides of type I collagen; BCE, bone collagen equivalent; Cr, creatinine.

Figure 1 Changes in lumbar spine and total hip BMD.

Notes: Data are expressed as the mean ± SD. A one-way ANOVA with repeated measurements showed significant longitudinal changes in the lumbar spine BMD (P < 0.0001). The mean rates of change in the lumbar spine BMD after 1, 2, and 3 years of treatment were +11.3%, +12.4%, and +14.8%, respectively. However, total hip BMD did not change significantly (P = 0.8706). The mean rates of change in the total hip BMD after 1, 2, and 3 years of treatment were −0.5%, +3.2%, and +6.4%, respectively.
Abbreviations: ANOVA, analysis of variance; BMD, bone mineral density.

Figure 2 Changes in biochemical markers.

Notes: Data are expressed as the mean ± SD. A one-way ANOVA with repeated measurements showed significant longitudinal changes in the serum ALP and urinary NTX levels (both P < 0.0001). The mean rates of change in the urinary NTX levels after 3 months of treatment were −42.5%. The mean rates of change in the serum ALP levels after 1, 2, and 3 years of treatment were −26.1%, −20.5%, and −18.9%, respectively. However, the serum calcium and phosphorus levels did not change significantly (P = 0.0760 and 0.8799, respectively).
Abbreviations: ANOVA, analysis of variance; ALP, alkaline phosphatase; NTX, cross linked N-terminal telopeptides of type I collagen; BCE, bone collagen equivalent; Cr, creatinine.

Table 2 Incidence of vertebral and nonvertebral fractures

Fracture	Incidence n (%)
Vertebral
Morphometric	7 (20.6%)
Clinical	2 (5.9%)
Nonvertebral
Hip	0 (0.0%)
Distal radius	0 (0.0%)
Proximal humerus	1 (2.9%)