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. |