Linked Life Data

8298200

Source:http://linkedlifedata.com/resource/pubmed/id/8298200

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:dateCreated
1994-3-10
pubmed:abstractText
The Fracture Intervention Trial (FIT) is a randomized, double-masked, placebo-controlled trial designed to test the hypothesis that alendronate, an amino-bisphosphonate, will reduce the rate of fractures in women aged 55-80 years with low hip bone marrow density (< 0.68 gm/cm2 at the femoral neck). It is being conducted at 11 clinical centers around the United States with a coordinating center at UC San Francisco. The goal was to randomize 6000 women. When recruitment was completed (in May 1993), 6457 women had been randomized, amounting to 108% of goal. The women were assigned to one of two substudies. The first (Vertebral Deformity study) includes 2023 women who have at least one vertebral deformity, and will test the hypothesis that alendronate reduces the rate of new vertebral deformities during 3 years of follow-up. This substudy has a power of 0.90 to detect a 32% reduction in the incidence of new vertebral deformities, assuming a 6.5% annual incidence of new vertebral deformities in the placebo group. The second study (Clinical Fracture study) includes 4434 women without vertebral deformities at baseline and will test the hypothesis that alendronate reduces the rate of clinically recognized fractures of all types over an average of 4.25 years of follow-up. This substudy has a 0.90 power to detect a 25% reduction in the rate of all clinical fractures, assuming 4% annual incidence in the placebo group. To our knowledge, this is the largest prospective, randomized, controlled study undertaken to determine the effectiveness of a treatment in reducing the risk of fractures in postmenopausal women.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0937-941X
pubmed:author
pubmed:issnType
Print
pubmed:volume
3 Suppl 3
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
S29-39
pubmed:dateRevised
2004-11-17
pubmed:meshHeading
pubmed:year
1993
pubmed:articleTitle
Design of the Fracture Intervention Trial.
pubmed:affiliation
Division of Clinical Epidemiology, University of California, San Francisco 94143.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Multicenter Study