Reference |
Study Population |
Treatment |
BMD Changes per Intention-to-Treat Analysis |
Effects on Incident Fractures or Fracture Risk |
Per Intention-to-Treat Analysis |
Per Protocol Analysis |
10 |
78 healthy women; mean age, 58 yr; median dietary calcium intake, 700 mg at baseline, 670 mg at 2 yr, 640 mg at 4 yr |
Calcium lactate–gluconate + calcium carbonate (1,000 mg elemental calcium) daily or placebo for 4 yr |
Increase in total body BMD over 4 yr greater with calcium vs. placebo (p = 0.002). Significant treatment effects also seen over 4 yr at lumbar spine (p = 0.03), femoral neck (p = 0.03), and trochanter (p = 0.01) |
Incident fractures (all sites) Calcium: 2 Placebo: 7 (p < 0.05) |
NA |
11 |
197 women, 47% with preexisting fractures; mean age, 74 yr; mean baseline dietary calcium intake, 432 mg |
Calcium carbonate (480 mg elemental calcium) per day or placebo for 4.3 ± 1.1 yr |
Change in forearm BMD with preexisting fracture Calcium: 0.31% ± 0.25% per yr (p < 0.05) Placebo: −1.24% ± 0.38% per yr Change in forearm BMD with no preexisting fracture Calcium: 0 ± 0.26% per yr (p > 0.05) Placebo: −0.39% ± 0.27% per yr |
Incident fractures with preexisting fracture Calcium: 15 Placebo: 21 (p < 0.05) Incident fractures with no preexisting fracture Calcium: 12 Placebo: 13 (p > 0.05) |
NA |
12 |
2,790 healthy women; mean age, 84 yr; baseline dietary calcium intake, 513 mg |
Tricalcium phosphate (1,200 mg elemental calcium) + 800 IU vitamin D3 per day or placebo for 1.5 yr |
Change in femoral neck BMD at 1.5 yr Calcium: 2.7% Placebo: −4.6% (p < 0.001) |
Nonvertebral fractures (no.) Treatment: 160 Placebo: 215 (p < 0.001) Hip fractures (no.) Treatment: 80 Placebo: 110 (p < 0.05) |
Subgroup analysis (n = 1,765) of new fracture incidence, by fracture site Nonvertebral Treatment: 66 Placebo: 97 (p < 0.05) Hip Treatment: 21 Placebo: 37 (p < 0.05) |
13 |
2,303 healthy women; mean age, 84 yr; baseline dietary calcium intake, 513 mg |
Tricalcium phosphate (1,200 mg elemental calcium) + 800 IU vitamin D3 per day or placebo for 3 yr |
Not reported |
Nonvertebral fractures (no.) Treatment: 255 Placebo: 308 (p < 0.05) OR for decreased probability of fracture, 0.72 (95% CI, 0.50–0.84) Hip fractures (no.) Treatment: 137 Placebo: 178 (p < 0.05) OR for decreased probability of fracture 0.73 (95% CI, 0.62–0.84) |
Subgroup analysis (n = 1,765) of probability and OR (treatment vs. placebo) of new fracture, by fracture site/type Nonvertebral: −24% (p < 0.01); OR, 0.70 (95% CI, 0.51–0.91) Hip: −29% (p < 0.01); OR, 0.70 (95% CI, 0.62–0.78) |
15 |
389 healthy women and men; mean age, 72 yr; baseline dietary calcium intake, 746 mg in women, 728 mg in men |
Calcium citrate (500 mg elemental calcium) + 700 IU vitamin D per day or placebo for 3 yr |
BMD change with treatment vs. placebo greater at femoral neck (0.5% vs. −0.7%; p = 0.02), lumbar spine (2.12% vs. 1.22%; p = 0.04), and for total body (0.06% vs. −1.09%; p < 0.001) |
RR of first nonvertebral fracture with treatment vs. placebo, 0.4 (95% CI, 0.2–1.0; p < 0.05) |
Cumulative incidence of first nonvertebral fracture Treatment: 5.9% Placebo: 12.9% (p < 0.05) RR (treatment vs. placebo) of first nonvertebral fracture, 0.5 (95% CI, 0.2–0.9) |
16 |
583 women; mean age, 85 yr; baseline dietary calcium intake, 558 mg/day; baseline vitamin D intake, 41 IU/day |
Tricalcium phosphate (1,200 mg elemental calcium) + 800 IU vitamin D3 per day or placebo for 2 yr |
Change in femoral neck BMD Calcium: 0.29% (p = 0.09) Placebo: −2.36% |
Hip fracture incidence Treatment: 6.9% Placebo: 11.1% (p = 0.07) RR of hip fracture with treatment vs. placebo, 1.69 (95% CI, 0.96–3.00) Nonvertebral fracture incidence Treatment: 17.8% Placebo: 17.9% (difference NS) |
NA |
17, 30 |
36,282 healthy women; mean age, 62 yr; mean baseline calcium intake from all sources, 1,148–1,154 mg/day; mean baseline calcium intake from diet alone, 678 mg/day |
Calcium carbonate (500 mg elemental calcium) + 200 IU vitamin D3 twice daily or placebo for 9 yr |
Increase in hip BMD at 9 yr 1.06% greater with treatment vs. placebo (p < 0.01); differences in spine and total body BMD changes with treatment vs. placebo at 9 yr NS |
HR (treatment vs. placebo) for fracture, by fracture site Hip: 0.88 (95% CI, 0.72–1.08); NS Vertebra: 0.90 (95% CI, 0.74–1.10); NS Lower arm or wrist: 1.01 (95% CI, 0.90–1.14); NS All sites: 0.96 (95% CI, 0.91–1.02); NS |
HR (treatment vs. placebo) for fracture, by fracture site Hip: 0.71 (95% CI, 0.52–0.97) Vertebra: 0.89 (95% CI, 0.67–1.19) Lower arm or wrist: 1.05 (95% CI, 0.90–1.23) Total fractures: 0.94 (95% CI, 0.87–1.02) |
18 |
1,471 healthy women; mean age, 74 yr; baseline daily calcium intake, 861 mg in treatment group, 853 mg in placebo group |
Calcium citrate (500 mg elemental calcium) twice daily or placebo for 5 yr |
BMD increases at 5 yr with calcium vs. placebo 1.6% greater for hip (p < 0.0001), 1.8% greater for lumbar spine (p < 0.0001), and 1.2% greater for total body (p < 0.0001) |
HR (treatment vs. placebo) for fracture, by fracture site/type Hip: 3.55 (95% CI, 1.31–9.63) Symptomatic: 0.91 (95% CI, 0.71–1.17); NS Osteoporotic: 0.87 (95% CI, 0.67–1.14); NS Vertebra: 0.72 (95% CI, 0.44–1.18); NS Distal forearm: 0.64 (95% CI, 0.40–1.03); NS |
HR (treatment vs. control) for fracture, by fracture site/type Hip: 2.12 (95% CI, 0.72–6.19) Symptomatic: 0.87 (95% CI, 0.67–1.14); NS Osteoporotic: 0.83 (95% CI, 0.62–1.10); NS Vertebra: 0.61 (95% CI, 0.33–1.11); NS Distal forearm: 0.43 (95% CI, 0.22–0.85) |
19 |
1,460 women; mean age, 75 yr; baseline daily calcium intake, 909 mg in treatment group, 934 mg in placebo group |
Calcium carbonate (240 mg elemental calcium) twice daily or placebo for 5 yr |
NA |
HR (treatment vs. placebo) for fracture, by site Upper limb: 0.93 (95% CI, 0.56–1.54); NS Wrist or hand: 1.10 (95% CI, 0.60–2.02); NS Rib or pelvis: 0.99 (95% CI, 0.55–1.78); NS Proximal femur: 1.84 (95% CI, 0.68–4.96); NS Lower limb: 0.58 (95% CI, 0.32–1.03); NS Any appendicular site: 0.88 (95% CI, 0.65–1.18); NS Spine: 0.98 (95% CI, 0.63–1.54); NS Any site: 0.87 (95% CI, 0.67–1.12); NS |
HR (treatment vs. placebo) for fracture, by fracture site Upper limb: 0.44 (95% CI, 0.21–0.92) Any appendicular site: 0.65 (95% CI, 0.43–0.97) Any site: 0.66 (95% CI, 0.45–0.97) Wrist or hand: 0.81 (95% CI, 0.35–1.88); NS Rib or pelvis: 0.71 (95% CI, 0.33–1.55); NS Proximal femur: 1.64 (95% CI, 0.39–6.87); NS Lower limb: 0.54 (95% CI, 0.25–1.18); NS Spine: 1.10 (95% CI, 0.42–2.84); NS |
20 |
3,314 women with at least one risk factor for osteoporosis; mean age, 77 yr; baseline daily calcium intake, 1,075–1,084 mg |
Calcium carbonate (500 mg elemental calcium) + 400 IU vitamin D twice daily for 2 yr + informational leaflet or leaflet only |
NA |
HR (treatment vs. control) for fracture, by fracture site Hip: 0.75 (95% CI, 0.31–1.78); NS Hip and wrist: 0.89 (95% CI, 0.56–1.44); NS All fractures: 1.01 (95% CI, 0.71–1.43); NS |
HR (treatment vs. control) for all fracture sites, 1.03 (95% CI, 0.68–1.56); NS |
21 |
5,292 men and women (85% women) with previous osteoporotic fracture; mean age, 77 yr; baseline daily calcium intake not reported |
Calcium carbonate (1,000 mg elemental calcium) alone vs. calcium carbonate + 800 IU vitamin D3 or placebo for 2–5 yr |
NA |
HR for new low-trauma fracture, by treatment variable Calcium carbonate vs. no calcium carbonate: 0.94 (95% CI, 0.81–1.09); NS Vitamin D3 vs. no vitamin D3: 1.01 (95% CI, 0.88–1.17); NS Calcium carbonate + vitamin D3 vs. placebo: 1.01 (95% CI, 0.75–1.36); NS |
HR for new fracture, by treatment variable Calcium carbonate vs. no calcium carbonate: 1.01 (95% CI, 0.70–1.48) Vitamin D3 vs. no vitamin D3: 1.01 (95% CI, 0.70–1.45) |
Comments