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Soft Drinks and Osteoporosis in WHI Participants

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ClinicalTrials.gov Identifier: NCT03371433
Recruitment Status : Completed
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Pedro Kremer, University of California, San Diego

Tracking Information
First Submitted Date December 7, 2017
First Posted Date December 13, 2017
Last Update Posted Date December 13, 2017
Actual Study Start Date July 1, 2016
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2017)
  • Lumbar spine osteoporosis [ Time Frame: median 16 years ]
    Bone mineral density lumbar spine measured in grams/square centimeters
  • Total hip osteoporosis [ Time Frame: median 16 years ]
    Bone mineral density at the total hip measured in grams/square centimeters
  • Hip fractures [ Time Frame: median 16 years ]
    Number of participants that suffered a hip fracture
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Soft Drinks and Osteoporosis in WHI Participants
Official Title Association Between Soft Drink Consumption and Osteoporotic Fractures Among Postmenopausal Women: The Women´s Health Initiative
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Osteoporosis
  • Diet Habit
Intervention Other: Soft drinks
Caffeine and Caffeine free soft drinks
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 11, 2017)
79885
Original Actual Enrollment Same as current
Actual Study Completion Date May 1, 2017
Actual Primary Completion Date May 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Postmenopausal women
  • More than one day of follow up
  • Dietary information on soft drinks

Exclusion Criteria:

Previous hip fracture

Sex/Gender
Sexes Eligible for Study: Female
Ages 50 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03371433
Other Study ID Numbers 170149XX
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pedro Kremer, University of California, San Diego
Study Sponsor University of California, San Diego
Collaborators Not Provided
Investigators Not Provided
PRS Account University of California, San Diego
Verification Date December 2017