Table 1

Characteristics of included studies

Study (reference)

Sample (ALN*/ control) and duration

Inclusion criteria

Age (years) (SD‡) Percentage prevalent vertebral fractures (VF, %)

Intervention/ Control

Blinding, randomization

Loss to follow-up or withdrew from study (n/N) (%)

Orwoll 2000 [11]

146/95 (2 years)

Men with BMD† T-score = -2 at femoral neck and T-score = -1 at the lumbar spine;

OR Men with T-score = -1 at the femoral neck and at least one vertebral or osteoporotic fracture

ALN:

Mean age 63 (13)

49% VF

Control: Mean age 63 (12)

52% VF

ALN*: 10 mg + 500 mg Calcium + 400–450 IU Vitamin D

Control: 500 mg Calcium + 400–450 IU Vitamin D

- Double-blind

- Radiologists reading vertebral x-rays blinded to intervention

-Method of randomization unclear

38/241 (15.8%)

Ringe 2004 [12]

68/66 (3 years)

Men with BMD† T-score = -2.5 at femoral neck or lumbar spine, excluding hypogonadal men

ALN*:

Mean age 52.7 (11.1)

54% VF

Control:

Mean age 53.3 (10.9)

53% VF

ALN*: 10 mg + 500 mg Calcium Control: 500 mg Calcium + 1 μg alfacalcidiol

- Open-label

- Radiologists reading vertebral x-rays blinded to intervention

-Method of randomization unclear

16/134 (11.9%)

*ALN, alendronate (daily dose)

\dagBMD, bone mineral density measurement by dual X-ray absorptiometry, compared to young adult male peak bone mass

\ddagSD, Standard deviation

Sawka et al. BMC Musculoskeletal Disorders 2005 6:39   doi:10.1186/1471-2474-6-39