PMID- 15728210
OWN - NLM
STAT- MEDLINE
DCOM- 20050609
LR  - 20220321
IS  - 0021-972X (Print)
IS  - 0021-972X (Linking)
VI  - 90
IP  - 5
DP  - 2005 May
TI  - Strontium ranelate reduces the risk of nonvertebral fractures in postmenopausal 
      women with osteoporosis: Treatment of Peripheral Osteoporosis (TROPOS) study.
PG  - 2816-22
AB  - BACKGROUND: Strontium ranelate, a new oral drug shown to reduce vertebral 
      fracture risk in postmenopausal women with osteoporosis, was studied in the 
      Treatment of Peripheral Osteoporosis (TROPOS) study to assess its efficacy and 
      safety in preventing nonvertebral fractures also. METHODS: Strontium ranelate (2 
      g/d) or placebo were randomly allocated to 5091 postmenopausal women with 
      osteoporosis in a double-blind placebo-controlled 5-yr study with a main 
      statistical analysis over 3 yr of treatment. FINDINGS: In the entire sample, 
      relative risk (RR) was reduced by 16% for all nonvertebral fractures (P = 0.04), 
      and by 19% for major fragility fractures (hip, wrist, pelvis and sacrum, ribs and 
      sternum, clavicle, humerus) (P = 0.031) in strontium ranelate-treated patients in 
      comparison with the placebo group. Among women at high risk of hip fracture (age 
      > or = 74 yr and femoral neck bone mineral density T score < or = -3, 
      corresponding to -2.4 according to NHANES reference) (n = 1977), the RR reduction 
      for hip fracture was 36% (P = 0.046). RR of vertebral fractures was reduced by 
      39% (P < 0.001) in the 3640 patients with spinal x-rays and by 45% in the 
      subgroup without prevalent vertebral fracture. Strontium ranelate increased bone 
      mineral density throughout the study, reaching at 3 yr (P < 0.001): +8.2% 
      (femoral neck) and +9.8% (total hip). Incidence of adverse events (AEs) was 
      similar in both groups. CONCLUSION: This study shows that strontium ranelate 
      significantly reduces the risk of all nonvertebral and in a high-risk subgroup, 
      hip fractures over a 3-yr period, and is well tolerated. It confirms that 
      strontium ranelate reduces vertebral fractures. Strontium ranelate offers a safe 
      and effective means of reducing the risk of fracture associated with 
      osteoporosis.
FAU - Reginster, J Y
AU  - Reginster JY
AD  - Department of Epidemiology, Public Health and Health Economics, University of 
      Liege, CHU Centre ville, 45 Quai Godefroid Kurth, 4020 Liege, Belgium. 
      jyreginster@ulg.ac.be
FAU - Seeman, E
AU  - Seeman E
FAU - De Vernejoul, M C
AU  - De Vernejoul MC
FAU - Adami, S
AU  - Adami S
FAU - Compston, J
AU  - Compston J
FAU - Phenekos, C
AU  - Phenekos C
FAU - Devogelaer, J P
AU  - Devogelaer JP
FAU - Curiel, M Diaz
AU  - Curiel MD
FAU - Sawicki, A
AU  - Sawicki A
FAU - Goemaere, S
AU  - Goemaere S
FAU - Sorensen, O H
AU  - Sorensen OH
FAU - Felsenberg, D
AU  - Felsenberg D
FAU - Meunier, P J
AU  - Meunier PJ
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20050222
PL  - United States
TA  - J Clin Endocrinol Metab
JT  - The Journal of clinical endocrinology and metabolism
JID - 0375362
RN  - 0 (Organometallic Compounds)
RN  - 0 (Thiophenes)
RN  - 04NQ160FRU (strontium ranelate)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Bone Density
MH  - Double-Blind Method
MH  - Female
MH  - Fractures, Bone/*prevention & control
MH  - Humans
MH  - Organometallic Compounds/adverse effects/*therapeutic use
MH  - Osteoporosis, Postmenopausal/*drug therapy
MH  - Spinal Fractures/prevention & control
MH  - Thiophenes/adverse effects/*therapeutic use
EDAT- 2005/02/25 09:00
MHDA- 2005/06/10 09:00
CRDT- 2005/02/25 09:00
PHST- 2005/02/25 09:00 [pubmed]
PHST- 2005/06/10 09:00 [medline]
PHST- 2005/02/25 09:00 [entrez]
AID - jc.2004-1774 [pii]
AID - 10.1210/jc.2004-1774 [doi]
PST - ppublish
SO  - J Clin Endocrinol Metab. 2005 May;90(5):2816-22. doi: 10.1210/jc.2004-1774. Epub 
      2005 Feb 22.