Data on fracture efficacy of strontium in regulatory documents and primary publications
| Participants | Vertebral fracture | Non-vertebral fracture | Hip fracture | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Strontium/ placebo (N) | Strontium/ placebo (n) | RR/HR/OR (95% CI) | p Value | Strontium/ placebo (n) | RR/HR/OR (95% CI) | p Value | Strontium/ placebo (n) | RR/HR/OR (95% CI) | p Value | |
| European Public Assessment Report 200512 | ||||||||||
| SOTI 3 years | 719/723 | 20.9%/32.8% | 0.59 (0.48 to 0.73) | <0.001 | NR | 0.91 (0.71 to 1.18)* | NR | NR | NR | NR |
| TROPOS 3 years | NR | NR | 0.61 (0.51 to 0.73) | NR | 233/276 | 0.85 (0.71 to 1.01)* | NR | 62/74 | 0.85 (0.61 to 1.19) | 0.33 |
| Pooled SOTI/TROPOS 3 years | 3295/3256 | NR | NR | NR | 331/389† | 0.85 (0.74 to 0.99)† | 0.033 | NR | NR | NR |
| Primary publications | ||||||||||
| SOTI 3 years 200416 | 719/723 | 20.9%/32.8% | 0.59 (0.48 to 0.73) | <0.001 | 112/122 | 0.90 (0.69 to 1.17)* | NR | NR | NR | NR |
| TROPOS 3 years 200517 | ||||||||||
| Vertebral fracture‡ | 1817/1823 | NR | 0.61 (0.51 to 0.73) | <0.001 | – | – | – | – | – | – |
| Non-vertebral fracture‡ | 2479/2453 | – | – | – | 11.2%/12.9% | 0.84 (0.70 to 1.0)* | 0.04 | 2.9%/3.4% | 0.85 (0.61 to 1.19) | NR |
| Cochrane review 200623 | ||||||||||
| Pooled SOTI/TROPOS 3 years | ||||||||||
| Vertebral fracture‡ | 2536/2546 | 341/543 | 0.63 (0.56 to 0.71) | <0.001 | – | – | – | – | – | – |
| Non-vertebral fracture‡ | 3305/3267 | – | – | – | 345/398† | 0.86 (0.75 to 0.98)† | 0.03 | NR | NR | NR |
| Periodic Safety Update Report 201313 | ||||||||||
| Pooled postmenopausal osteoporosis | ||||||||||
| Vertebral fracture‡ | 2924/2945§ | 508/663§ | 0.72 (0.64 to 0.82)§ | <0.0001 | – | – | – | – | – | – |
| Non-vertebral fracture‡ | 3748/3711 | – | – | – | 426/492§ | 0.84 (0.73 to 0.96)§ | 0.013 | 109/114§ | 0.95 (0.72 to 1.23)§ | 0.68 |
| CHMP scientific conclusion/PRAC assessment report 20146 | ||||||||||
| Pooled postmenopausal osteoporosis | ||||||||||
| Vertebral fracture‡ | 2917/2939§ | 507/661§ | 0.73 (0.64–0.83)§ | <0.001 | ||||||
| Peripheral fracture‡ | 3748/3711 | 427/492§ | 0.84 (0.73 to 0.97)§ | 0.014 | 111/114§ | 0.96 (0.74 to 1.26) § | 0.78 | |||
| Primary publications | ||||||||||
| STRATOS 200215 | 87/91 | 42.0%/57.4% | 0.77 (0.54 to 1.09) | NR | 9.2%/7.7% | NR | NR | NR | NR | NR |
| SOTI 4 years 200921 | 719/726¶ | 27.0%/36.4% | 0.67 (0.55 to 0.81) | <0.001 | NR | 0.92 (0.72 to 1.19) | NR | NR | NR | NR |
| TROPOS 5 years 200819 | ||||||||||
| Vertebral fracture‡ | 1819/1827¶ | 20.8%/24.9% | 0.76 (0.65 to 0.88) | <0.001 | – | – | – | – | – | – |
| Non-vertebral fracture‡ | 2479/2456¶ | – | – | – | 312/359 | 0.85 (0.73 to 0.99) | 0.032 | 88/98 | NR | NR |
| Hwang 200818 | 64/61 | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Liu 200920 | 151/151 | 3/7 | NR | NR | NR | NR | NR | NR | NR | NR |
| Pooled analysis | – | – | 0.73 (0.65 to 0.81) | <0.001 | – | 0.87 (0.77 to 0.99) | 0.04 | – | 0.89 (0.67 to 1.18) | 0.42 |
*Data differs between primary publication and regulatory document.
†Number of participants with fracture differs between Cochrane review and regulatory documents.
‡Morphometric vertebral fractures were assessed in a subset of participants in TROPOS.
§Data differs between 2013 and 2014 regulatory documents.
¶Number of participants differs from earlier primary publications and regulatory documents.
NR, not reported; RR, relative risk.