Gorai 1999.

Study characteristics
Methods	Random allocation List of randomly generated treatment codes prepared by 1 of the investigators No blinding of outcome assessors reported Completion rate unclear
Participants	Outpatient study, Japan 44 women, average age 51 years Inclusion criteria: postmenopausal women with at least 1 year but not more than 5 years since last menses Disease exclusions: surgical menopause, chronic disease (renal disease, hyperparathyroidism, diabetes mellitus), compression fracture on thoracic or lumbar spine radiograph Drug exclusions: drug treatment known to affect bone metabolism
Interventions	1. 1 μg 1‐alphahydroxyvitamin D3 daily Randomised 20, completed unclear 2. No intervention Randomised 24, completed unclear 3. 1 μg 1‐alphahydroxyvitamin D3 and 0.625 mg conjugated oestrogen daily (group not used in this review) 4. 0.625 mg conjugated oestrogen daily (group not used in this review) Duration of treatment 2 years
Outcomes	Measured at 2 years 1. Number of persons sustaining new vertebral fracture 2. Number of persons with hypercalcaemia 3. BMD of lumbar spine and femoral neck 4. Biochemical markers of bone formation and breakdown
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	States "randomly generated treatment codes previously prepared by a controller": Y Misu who was one of the investigators; no other information provided
Allocation concealment (selection bias)	Unclear risk	No details provided