Skip to main content
OpenTrials
Completed

NCT Number: NCT03371433

Soft Drinks and Osteoporosis in WHI Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Previous hip fracture

Treatment and study plan

Soft drinks

Other

Caffeine and Caffeine free soft drinks

Primary outcomes

  1. Lumbar spine osteoporosis

    Time frame: median 16 years

    Bone mineral density lumbar spine measured in grams/square centimeters

  2. Total hip osteoporosis

    Time frame: median 16 years

    Bone mineral density at the total hip measured in grams/square centimeters

  3. Hip fractures

    Time frame: median 16 years

    Number of participants that suffered a hip fracture

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Association Between Soft Drink Consumption and Osteoporotic Fractures Among Postmenopausal Women: The Women´s Health Initiative

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 13, 2017
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.