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. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3

Harwood 2004.

Study characteristics
Methods RCT
Participants Setting: Nottingham, United Kingdom
N = 150
Sample: women admitted to orthogeriatric rehabilitation ward within 7 days of surgery for hip fracture
Age (years): mean 81.2, range 67 to 92
Inclusion criteria: recent surgery for hip fracture; previous community residence; previous independence in ADL
Exclusion criteria: previously institutionalised; disease or medication known to affect bone metabolism; < 7 on 10‐point mental state score
Interventions 1. Single injection of vitamin D2 (ergocalciferol) 300,000 units
2. Single injection of vitamin D2 (ergocalciferol) 300,000 units plus oral calcium carbonate (Calcichew) 1 tablet x 2/day (1 g elemental calcium daily)
3. Oral vitamin D3 + calcium carbonate (Calceos) 1 tablet x 2/day (cholecalciferol 800 units/day + calcium 1 g/day)
4. Control: no treatment
Outcomes 1. Number of people falling
2. Number sustaining a fracture
3. Number of people with adverse effects
Other outcomes reported but not included in this review
Duration of the study 1 year
Notes Recruited in hospital but meets the inclusion criteria as participants were all community‐dwelling and intervention was designed to prevent falls in the community
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised to 4 groups by computer‐generated random number lists
Allocation concealment (selection bias) Unclear risk Quote: "using sealed, opaque, envelopes"
Blinding of participants and personnel (performance bias)
All outcomes High risk No placebo was used; participants aware of whether they were receiving medication or no treatment
Blinding of outcome assessment (detection bias)
Falls and fallers High risk Falls reported at intervals by participants to researchers who were aware of their group allocation
Blinding of outcome assessment (detection bias)
Fractures High risk Fractures reported by participants to researchers who were aware of their group allocation. Fracture reports were not verified.
Incomplete outcome data (attrition bias)
Fallers High risk SeeAppendix 3 for method of assessment
Risk of bias in recall of falls High risk Falls not recorded in diaries. Presume falls and fractures ascertained at dedicated clinic at 3, 6 and 12 months.