Document Detail


Design and methodology of the phase 3 trials for the clinical development of strontium ranelate in the treatment of women with postmenopausal osteoporosis.
MedLine Citation:
PMID:  12730769     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The phase 3 program for strontium ranelate, a new oral agent in the treatment of women with postmenopausal osteoporosis, was aimed to assess the efficacy and safety of the daily oral dose of 2 g. This program was conducted in 12 countries, involved 75 centers, and was structured in 3 studies: FIRST (Fracture International Run-in for Strontium ranelate Trial), SOTI (Spinal Osteoporosis Therapeutic Intervention study) and TROPOS (TReatment Of Peripheral OSteoporosis). FIRST, a run-in open study, was designed to start the normalization of the calcium and vitamin D status of the patients, check all entry criteria, and ensure inclusion of a sufficient number of well-motivated patients in either one of the two therapeutic intervention protocols, SOTI or TROPOS: FIRST included 9,196 patients. SOTI and TROPOS were prospective, randomized, double-blind clinical trials comparing, in two parallel groups, the daily oral dose of 2 g of strontium ranelate with placebo, the patients of both groups receiving calcium and vitamin D according to their own deficiencies. The main objective of SOTI and TROPOS was to demonstrate a reduction in the incidence of postmenopausal women experiencing a new osteoporotic fracture (vertebral fracture in SOTI and nonvertebral fracture in TROPOS) over a 3-year treatment period, the total duration of the studies being 5 years. SOTI included 1,649 women with at least one osteoporotic vertebral fracture at inclusion and a lumbar BMD </=0.840 g/cm(2). TROPOS included 5,091 women with a femoral neck BMD </=0.600 g/cm(2). The phase 3 program for the clinical development of strontium ranelate in women with postmenopausal osteoporosis is a long-term program with the main statistical analysis after 3 years of treatment. Its aim is to demonstrate the effect of strontium ranelate on the axial and appendicular skeleton as well as its tolerability in osteoporotic patients with replete calcium and vitamin D stores.
Authors:
P J Meunier; J Y Reginster
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2003-03-12
Journal Detail:
Title:  Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA     Volume:  14 Suppl 3     ISSN:  0937-941X     ISO Abbreviation:  Osteoporos Int     Publication Date:  2003  
Date Detail:
Created Date:  2003-05-13     Completed Date:  2003-09-26     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  9100105     Medline TA:  Osteoporos Int     Country:  England    
Other Details:
Languages:  eng     Pagination:  S66-76     Citation Subset:  IM    
Affiliation:
Department of Rheumatology and Bone Diseases, Pavillon F, Hôpital Edouard Herriot, 69437, Lyon Cedex 3, France.
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MeSH Terms
Descriptor/Qualifier:
Aged
Calcium / metabolism
Double-Blind Method
Female
Humans
Organometallic Compounds / therapeutic use*
Osteoporosis, Postmenopausal / drug therapy*
Prospective Studies
Research Design
Thiophenes / therapeutic use*
Treatment Outcome
Vitamin D / metabolism
Chemical
Reg. No./Substance:
0/Organometallic Compounds; 0/Thiophenes; 0/strontium ranelate; 1406-16-2/Vitamin D; 7440-70-2/Calcium

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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