NCT03371433

Soft Drinks and Osteoporosis in WHI Participants

Completed Last updated 13 December 2017

What this trial tests

trial testing Soft drinks in Osteoporosis in 79,885 participants. Completed in 1 May 2017.

Timeline

1 July 2016

Primary endpoint
1 May 2017

1 May 2017

Quick facts

Lead sponsor	University of California, San Diego
Status	Completed
Study type	OBSERVATIONAL
Enrollment	79,885
Start date	1 July 2016
Primary completion	1 May 2017
Estimated completion	1 May 2017

Drugs / interventions tested

• Soft drinks

Conditions studied

• Osteoporosis — all drugs for Osteoporosis →
• Diet Habit — all drugs for Diet Habit →

Sponsor

University of California, San Diego

Who can join

Adults 50 to 79, female only, with Osteoporosis or Diet Habit. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.