Soft Drinks and Osteoporosis in WHI Participants

Completed

• Conditions: Diet Habit; Osteoporosis

• Registration Number: NCT03371433
• Lead Sponsor: University of California, San Diego

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 available

Study Timeline

• Study Start: 2016-07-01
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-11
• Last Update Submitted: 2017-12-11
• Study First Posted: 2017-12-13
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 79885

Inclusion Criteria

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

Exclusion Criteria

Previous hip fracture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lumbar spine osteoporosis	median 16 years	Bone mineral density lumbar spine measured in grams/square centimeters
Total hip osteoporosis	median 16 years	Bone mineral density at the total hip measured in grams/square centimeters
Hip fractures	median 16 years	Number of participants that suffered a hip fracture