Soft Drinks and Osteoporosis in WHI Participants

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371433
• Other study ID #: 170149XX
• Status: Completed
• Phase: N/A
• First received: December 7, 2017
• Last updated: December 11, 2017
• Start date: July 1, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: December 2017
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79885
• Est. completion date: May 1, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 79 Years

Eligibility

Inclusion Criteria:

• Postmenopausal women

• More than one day of follow up

• Dietary information on soft drinks

Exclusion Criteria:

Previous hip fracture

Related Conditions & MeSH terms

• Diet Habit
• Osteoporosis

Intervention

Other:
• Soft drinks
Caffeine and Caffeine free soft drinks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

References & Publications (11)

Chen Z, Kooperberg C, Pettinger MB, Bassford T, Cauley JA, LaCroix AZ, Lewis CE, Kipersztok S, Borne C, Jackson RD. Validity of self-report for fractures among a multiethnic cohort of postmenopausal women: results from the Women's Health Initiative observational study and clinical trials. Menopause. 2004 May-Jun;11(3):264-74. — View Citation

Cuomo R, Sarnelli G, Savarese MF, Buyckx M. Carbonated beverages and gastrointestinal system: between myth and reality. Nutr Metab Cardiovasc Dis. 2009 Dec;19(10):683-9. doi: 10.1016/j.numecd.2009.03.020. Epub 2009 Jun 6. Review. — View Citation

Design of the Women's Health Initiative clinical trial and observational study. The Women's Health Initiative Study Group. Control Clin Trials. 1998 Feb;19(1):61-109. — View Citation

Fitzpatrick L, Heaney RP. Got soda? J Bone Miner Res. 2003 Sep;18(9):1570-2. — View Citation

Fung TT, Arasaratnam MH, Grodstein F, Katz JN, Rosner B, Willett WC, Feskanich D. Soda consumption and risk of hip fractures in postmenopausal women in the Nurses' Health Study. Am J Clin Nutr. 2014 Sep;100(3):953-8. doi: 10.3945/ajcn.114.083352. Epub 2014 Aug 6. — View Citation

Johnell O, Kanis JA. An estimate of the worldwide prevalence, mortality and disability associated with hip fracture. Osteoporos Int. 2004 Nov;15(11):897-902. Epub 2004 May 4. — View Citation

Kim SH, Morton DJ, Barrett-Connor EL. Carbonated beverage consumption and bone mineral density among older women: the Rancho Bernardo Study. Am J Public Health. 1997 Feb;87(2):276-9. — View Citation

Ogur R, Uysal B, Ogur T, Yaman H, Oztas E, Ozdemir A, Hasde M. Evaluation of the effect of cola drinks on bone mineral density and associated factors. Basic Clin Pharmacol Toxicol. 2007 May;100(5):334-8. — View Citation

Park S, Xu F, Town M, Blanck HM. Prevalence of Sugar-Sweetened Beverage Intake Among Adults--23 States and the District of Columbia, 2013. MMWR Morb Mortal Wkly Rep. 2016 Feb 26;65(7):169-74. doi: 10.15585/mmwr.mm6507a1. — View Citation

Tucker KL, Morita K, Qiao N, Hannan MT, Cupples LA, Kiel DP. Colas, but not other carbonated beverages, are associated with low bone mineral density in older women: The Framingham Osteoporosis Study. Am J Clin Nutr. 2006 Oct;84(4):936-42. — View Citation

Wyshak G, Frisch RE. Carbonated beverages, dietary calcium, the dietary calcium/phosphorus ratio, and bone fractures in girls and boys. J Adolesc Health. 1994 May;15(3):210-5. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar spine osteoporosis	Bone mineral density lumbar spine measured in grams/square centimeters	median 16 years
Primary	Total hip osteoporosis	Bone mineral density at the total hip measured in grams/square centimeters	median 16 years
Primary	Hip fractures	Number of participants that suffered a hip fracture	median 16 years