Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2003
Design and methodology of the phase 3 trials for the clinical development of strontium ranelate in the treatment of women with postmenopausal osteoporosis.
Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.
- Vertebral anti-fracture efficacy of strontium ranelate according to pre-treatment bone turnover.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2010Pooled it
- Strontium ranelate for preventing and treating postmenopausal osteoporosis.The Cochrane database of systematic reviews · 2006Pooled it
- Effects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2009Trial
- A comparison of adverse event and fracture efficacy data for strontium ranelate in regulatory documents and the publication record.BMJ open · 2014Review
- Addressing the age-related needs of osteoporotic patients with strontium ranelate.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2010Review
- Strontium ranelate: new data on fracture prevention and mechanisms of action.Current osteoporosis reports · 2009Review
- Estimation of direct unit costs associated with non-vertebral osteoporotic fractures in five European countries.Rheumatology international · 2006Review
- Structural studies of human alkaline phosphatase in complex with strontium: implication for its secondary effect in bones.Protein science : a publication of the Protein Society · 2006Article
- Clinical effects of strontium ranelate in women with postmenopausal osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2005Review
- A review of anabolic therapies for osteoporosis.Arthritis research & therapy · 2003Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.