Efficacy and Safety of Generic Alendronate for Osteoporosis Treatment

Figures & data

Figure 1 Flow diagram of patients in this study.

Table 1 Patients’ Demographic Data

Clinical Variables	Data (n = 120)
Age (years)	69.0 ± 9.3
Gender (female, %)	116 (96.7%)
Body mass index (kg/m^2)	22.3 ± 4.0
Charlton comorbidity index (%)
- 0–1	108 (90.0%)
- 2–3	11 (9.2%)
- >3	1 (0.8%)
Previous fractures (%)
- None	81 (67.5%)
- Hip	6 (5.0%)
- Spine	33 (27.5%)
Baseline BMD (g/cm^2)
- Lumbar spine	0.72 ± 0.11
- Femoral neck	0.65 ± 0.11
- Total hip	0.53 ± 0.09

Note: Data are presented as mean ± standard deviation for age, body mass index, and baseline BMD.

Abbreviations: kg/m², kilogram/meter²; g/cm², gram/centimeter²; BMD, bone mineral density.

Table 2 Changes of BMD After One Year of Generic Alendronate Treatment

Location	BMD value (n = 120)	p-value
Lumbar spine
- Baseline (g/cm^2)	0.72 ± 0.11
- 1 year (g/cm^2)	0.77 ± 0.13	<0.001
- Percent change at 1 year	5.6 ± 13.7
Femoral neck
- Baseline (g/cm^2)	0.53 ± 0.09
- 1 year (g/cm^2)	0.54 ± 0.08	0.023
- Percent change at 1 year	2.3 ± 8.3
Total hip
- Baseline (g/cm^2)	0.65 ± 0.11
- 1 year (g/cm^2)	0.66 ± 0.11	0.003
- Percent change at 1 year	2.1 ± 6.2

Notes: Data are presented as mean ± standard deviation except for percent change at 1 year. p-value <0.05 indicates the statistically significant differences.

Abbreviation: g/cm², gram/centimeter².

Table 3 Patients with Stable, Increased, and Decreased BMD After 1 Year of Generic Alendronate Treatment

Location	BMD
	Increased	Stable	Decreased
Lumbar spine^a	65 (67.0%)	22 (22.7%)	10 (10.3%)
Femoral neck^b	26 (25.5%)	63 (61.8%)	13 (12.7%)
Total hip^b	26 (25.5%)	66 (64.7%)	10 (9.8%)

Notes: Data are presented as numbers and percentages. ^aLumbar spine BMD was classified as increased if the amount of BMD gain was ≥3%, stable if the percentage change was between −3 and 3%, and decreased if the amount of BMD loss was ≥3%. ^bFemoral neck and total hip BMDs were categorized as increased if the amount of BMD gain was ≥5%, stable if the percentage change was between −5 and 5%, and decreased if the amount of BMD loss was ≥5%.