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Trial record 6 of 32 for:    women's health initiative

Soft Drinks and Osteoporosis in WHI Participants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03371433
First Posted: December 13, 2017
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pedro Kremer, University of California, San Diego
  Purpose

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.


Condition Intervention
Osteoporosis Diet Habit Other: Soft drinks

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Association Between Soft Drink Consumption and Osteoporotic Fractures Among Postmenopausal Women: The Women´s Health Initiative

Resource links provided by NLM:


Further study details as provided by Pedro Kremer, University of California, San Diego:

Primary Outcome Measures:
  • 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


Enrollment: 79885
Actual Study Start Date: July 1, 2016
Study Completion Date: May 1, 2017
Primary Completion Date: May 1, 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Soft drinks
    Caffeine and Caffeine free soft drinks
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Previous hip fracture

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:

Responsible Party: Pedro Kremer, MD, MPH, Doctoral Student, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03371433     History of Changes
Other Study ID Numbers: 170149XX
First Submitted: December 7, 2017
First Posted: December 13, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pedro Kremer, University of California, San Diego:
Osteoporosis
Hip Fractures
Soft Drinks

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases