Study characteristics |
Methods |
RCT |
Participants |
Setting: Zurich, Switzerland
N = 24
Sample: probably female patients in Center for Osteoporosis of the Department of Rheumatology
Age (years): mean 71.2 (SD 6.8)
Inclusion criteria: aged ≥ 65; living independently; with osteoporosis or osteopenia
Exclusion criteria: severe peripheral or central neurological disease known to influence gait, balance or muscle strength; medical contraindications for exercise |
Interventions |
1. Intervention: vitamin 400 to 800 IU cholecalciferol and calcium 500 to 1000 mg/day according to physician assessment at baseline plus 12 wk training programme to improve balance, and a daily nutritional supplement enriched with proteins for 3 months
2. Control: vitamin 400 to 800 IU cholecalciferol and calcium 500 to 1000 mg/day according to physician assessment at baseline plus leaflet on home exercises |
Outcomes |
1. Rate of falls
Other outcomes reported but not included in this review |
Duration of the study |
1 year |
Notes |
Pilot study |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Quote: "Random assignment ... with a stratified randomisation procedure." |
Allocation concealment (selection bias) |
Unclear risk |
Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Blinding of participants and treatment personnel not mentioned in report, but unlikely. Insufficient evidence to make judgement on impact of lack of blinding. |
Blinding of outcome assessment (detection bias)
Falls and fallers |
Low risk |
Falls reported by participants who were aware of their group allocation. Outcome assessors were blind to allocation. |
Incomplete outcome data (attrition bias)
Falls |
Unclear risk |
SeeAppendix 3 for method of assessment |
Risk of bias in recall of falls |
High risk |
Quote: "Falls were assessed by interview at each assessment" post intervention, 6, 9, and 12 months. Interval recall of 3‐month period. |