An observational study in Osteoporosis and Diet Habit, sponsored by University of California, San Diego. Completed. Open to female participants aged 50 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by University of California, San Diego · Observational
Osteoporotic fractures, as a consequence of a reduced mineral bone density (BMD) represents a major public health problem. The lifetime risk of fractures exceeds 40% for women and 13% for men. At least ten different individual characteristics have already been proposed, evaluated, and some of them accepted as risk factors. Some of those risk factors were compiled in a tool developed by the World Health Organization in order to predict the ten-risk for a new fracture, even without considering BMD in that prediction . Increased consumption of carbonated soft drinks has been reported to have associations to a lower bone mineral density and an increment in bone fractures among young and also elder subjects.
However, some prospective studies have not found any significant associations and others suggested that risk is only increased for some kinds of beverages, like cola beverages, but not to the entire universe of soft drinks. In this sense, a large prospective analysis performed on 1413 women and 1125 men from the Framingham Offspring Cohort, analyzed- the relation between soft drinks consumption and BMD at the spine and 3 hip sites. Cola intake was associated with significantly lower BMD at each hip site, but not the spine, in women but not in men. Similar results were observed for diet cola and, although weaker, for decaffeinated cola. No significant relations between non-cola carbonated beverage consumption and BMD were observed.
In spite of the fact that reduced bone mineral density and osteoporotic fractures represent an increasing burden of disease and disability in postmenopausal women, most of the studies performed in this population used BMD as primary outcome, and not common osteoporotic fractures (e.g. hip, spine or wrist). Therefore, there is no conclusive evidence of a potential causal association between soft drinks (cola and non-cola) and fractures in a population in which osteoporotic fractures hold the highest incidence.
This research proposal is based on using the Women Health Initiative data to analyze the relation between cola and non-cola soft drinks consumption on common osteoporotic fractures. BMD will be considered a secondary outcome.
1,675 studies on the registry are indexed under Osteoporosis; 211 are open to participants now.
This study's enrollment of 79,885 is above the median of 180 across 461 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →University of California, San Diego is the lead sponsor of 975 studies on the registry; 196 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 71 (64%) have results posted.
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The WHI is an ongoing national study that enrolled 161,808 postmenopausal women aged 50-79 at baseline, enrolled during 1993-1998. Data collection at screening and enrollment included questionnaires completed by self-report or interview, physical examination, and blood specimen collection. Information on soda intake (total, caffeinated and caffeine-free) was collected at the sixth follow-up year in the OS among 79,885 women who form the baseline study population for this analysis. After exclusion of participants who had incomplete exposure information (n=5,413), had previous history of hip fracture (n=471), or less than one day of follow up after Year 6 (n=1659), a cohort of 72,342 participants contributing 700,388 person/years of follow-up was used for the prospective analysis. All participants provided informed consent at baseline and subsequently for extended follow-up.
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Exclusion Criteria:
Previous hip fracture
Caffeine and Caffeine free soft drinks
Lumbar spine osteoporosis
Bone mineral density lumbar spine measured in grams/square centimeters
Time frame: median 16 years
Total hip osteoporosis
Bone mineral density at the total hip measured in grams/square centimeters
Time frame: median 16 years
Hip fractures
Number of participants that suffered a hip fracture
Time frame: median 16 years
No study locations are listed for this record.
Plan to share: No
Ran from Jul 2016 to primary completion in May 2017, 10 months.
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This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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