Participants | Venous thromboembolism | Pulmonary embolus | Myocardial infarction | |||||
---|---|---|---|---|---|---|---|---|
Strontium/placebo (N) | Strontium/placebo (n) | RR/HR/OR (95% CI) | Strontium/placebo (n) | RR/HR/OR (95% CI) | Strontium/placebo (n) | RR/HR/OR (95% CI) | p Value | |
European Public Assessment Report 200512 | ||||||||
Pooled SOTI/TROPOS | 3352/3317 | NR | 1.5 (1.1 to 2.1) | 25/15 | 1.7 (1.0 to 3.1) | NR | NR | NR |
Primary publications | ||||||||
SOTI 3 years 200416 | 826/814 | NR | NR | NR | NR | NR | NR | NR |
TROPOS 3 years 200517 | 2526/2503 | NR | NR | NR | NR | NR | NR | NR |
Cochrane review 200623 | ||||||||
Pooled SOTI/TROPOS 3 years | 3352/3317 | 75/50* | 1.5 (1.1 to 2.1) | 25/15 | 1.7 (1.0 to 3.1) | NR | NR | NR |
Pooled SOTI/TROPOS 4 years | 3352/3317 | 87/61* | NR | NR | NR | NR | NR | NR |
Assessment of Adverse Effects 2012/Periodic Safety Update Report 20134 13 | ||||||||
STRATOS | 87/91 | NI | NI | NI | NI | 0/1 | NR | NR |
‘PREVOS 005’ | 56/57 | NI | NI | NI | NI | 0/0 | – | – |
SOTI | 826/814 | NI | NI | NI | NI | 6/9 | NR | NR |
TROPOS 5 years | 2526/2503 | NI | NI | NI | NI | 58/30 | NR | NR |
Hwang 2008 | 67/65 | NI | NI | NI | NI | 0/0 | – | – |
Liu 2009 | 164/165 | NI | NI | NI | NI | 0/0 | – | – |
‘CL3–017’ | 77/74 | NI | NI | NI | NI | 0/0 | – | – |
Pooled SOTI/TROPOS | 3352/3317 | NR | 1.4 (1.0 to 2.0) | NR | NR | NR | NR | NR |
Pooled postmenopausal osteoporosis | 3803/3769 | 89/65* | 1.4 (1.0 to 1.9) | NR | NR | 64/40 | 1.6 (1.1 to 2.4) | 0.02 |
MALEO | 173/87 | 3/0 | NR | 1/0 | NR | 3/1 | NR | NR |
SEKOIA/‘CL3-028’ | 586/577 | 3/1 | NR | 2/1 | NR | 5/1 | NR | NR |
CHMP scientific conclusion/PRAC assessment report 20146 | ||||||||
Pooled postmenopausal osteoporosis | 3803/3769 | 71/47* | 1.5 (1.0 to 2.2) | NR | NR | 64/40 | 1.6 (1.1 to 2.4) | 0.02 |
Primary publications | ||||||||
STRATOS 200215 | 87/91 | NR | NR | NR | NR | NR | NR | NR |
SOTI 4 years 200921 | 828/821 | 8/5 | NR | NR | NR | NR | NR | NR |
TROPOS 5 years 200819 | 2526/2503 | 2.7%/2.1% | 1.3 (0.9 to 1.9) | NR | NR | NR | NR | NR |
Hwang 200818 | 64/61 | NR | NR | NR | NR | NR | NR | NR |
Liu 200920 | 164/165 | 0/0 | – | NR | NR | NR | NR | NR |
MALEO 20132 | 173/87 | 3/0 | NR | 1/0 | NR | NR | NR | NR |
SEKOIA 201322 | 564/556 | 3/2 | NR | 2/1 | NR | NR | NR | NR |
*Number with venous thromboembolism differs between 2013 and 2014 regulatory analyses, and between those analyses and the earlier Cochrane review.
NI, not included; NR, not reported; RR, relative risk.