TABLE 1.
Data extraction table
| Author & Year | No: of participants (% of women) | Age/ mean age | Country and study setting | Type of study | Medication in intervention group: oral supplementation of | Control group | Trial Duration | Hip fracture incidence | Non‐vertebral fracture | Femoral neck Bone mineral density | Risk of bias | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vit D3 (IU) | Calcium (mg) | |||||||||||
| Chapuy et al. (1992) | 2790 (100) | 69–106 years |
France Nursing homes or apartment houses for elderly people |
RCT | 800 | 1200 (tricalcium phosphate) | Placebo | 18 months | The total incidence of hip fracture is 80/1387 (Intervention group), 110/1403 (Control group). (p = 0.043) | Non vertebral fracture: 160/1387 (intervention group), 215/1403 (control group (p = 0.015) | Femoral BMD +2.9 + _6.4 (intervention group), +1.8 + _9.4 (control group) (p = 0.036) | Randomly assigned to vitamin D ‐ calcium group or the placebo group in groups of 4., Placebo controlled, ITT analysis |
| Chapuy et al. (1994) | 2303 (100) | 84 (mean age) | France, Nursing homes or apartment houses for elderly people | RCT | 800 | 1200 (tricalcium phosphate) | Placebo | 36 months | Hip fracture: 138/1176 (intervention group), 184/ 1127 (control group) (OR = 0.70; 95% CI, 0.62,0.78) | Non vertebral fracture: 301/1176 (Intervention group), 368/1127 (Control group). (OR 0.70; 95% CI, 0.51,0.91) | NA | Unclear Randomization method, Placebo controlled, ITT analysis |
| Dawson‐Hughes et al. (1997) | 389 (55) | 65+ |
United States Community Dwelling |
Double blinded, placebo‐ controlled trial | 700 | 500 (Calcium citrate malate) | Placebo | 36 months | Hip fracture: 0/187 (intervention group), 1/202 (Control group) | Non vertebral fracture: 11/187 (intervention group), 26/202 (control group) (p = 0.03). | Femoral neck BMD: +0.18 + _1.90 (intervention group), −0.22 + _ 3.65 (control group), (p = 0.02). | Unclear randomization, Double blinded throughout treatment period, Placebo controlled, ITT analysis. |
| Chapuy et al. (2002) | 583 (100) | Mean age 85 years |
France Apartment Houses for the elderly. |
RCT | 800 | 1200 (tricalcium phosphate) | Placebo | 24 months | Hip fracture: 27/393 (Intervention Group), 21/190 (Control group) (p = 0.07) | Non vertebral fracture: 69/393 (intervention group), 34/190 (control group) | Femoral neck BMD ‐1.2 + _6.4 (intervention group). ‐4.5 + _ 7.1 (control group) | Unclear randomization method, Double blinded throughout treatment period, Placebo controlled, ITT analysis |
| Porthouse et al. (2005) | 3314 (100) | ≥ 70 years |
England Practice nurse led clinics in primary care. |
Pragmatic open RCT | 800 | 1000 (calcium carbonate) | Nil | 18–42 months |
Hip fracture 8/1321 (Intervention group), 17/1993 (Control group). OR 0.75; 95% CI, 0.31,1.78. p = 0.51 |
Non vertebral fracture: 58/1321 (intervention group), 91/1993 control group). OR 1.01; 95% CI, 0.71, 1.43) |
NA | Computer based randomization, Pragmatic, open controlled trial, No medication in control group, ITT analysis |
| RECORD Trial Group (2005) | 2638 (85) | 70 years or older |
UK 21 hospitals in the UK |
RCT | 800 | 1000 (calcium carbonate) | Placebo | 24–62 months | Hip fracture 46/1306 (Intervention group), 41/1332 (control group) | Non vertebral fracture: 165/ 1306 (intervention group), 178/1332 (control group). | NA | Computer based randomization, Double blinded throughout treatment period, Placebo controlled, Masking of treatment allocation stated, ITT analysis |
| Salovaara et al. (2010) | 375 (100) | 65–71 |
Finland Bone and cartilage Research unit of the clinical research centre of the University of Kuopio, Finland |
RCT | 800 | 1000 (calcium carbonate) | Nil | 52 months |
Hip fracture 4/290 (intervention group), 2/313 (control group) Hazard Ratio 2.19 (0.40–12.00) |
Non vertebral fracture: 77/290 (intervention group), 82/313 (control group) HR 0.89 (0.65–1.22) | NA | Randomization done by an independent statistician using Windows 11.0, Participants in the control group did not receive any intervention or placebo, ITT analysis |