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%) |