Validation of a Revised Food Frequency Questionnaire



Status:Recruiting
Conditions:Food Studies, Osteoporosis
Therapuetic Areas:Pharmacology / Toxicology, Rheumatology
Healthy:No
Age Range:65 - Any
Updated:2/23/2018
Start Date:March 2016
End Date:June 2018
Contact:Laura AG Armas, MD,MS
Email:laura.armas@unmc.edu
Phone:402-559-6310

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Validation of a Revised Food Frequency Questionnaire in a Population of Elderly Men and Women With Fragility Fractures and Correlation With Bone Mineral Density and Biochemical Markers

The purpose of this study is to validate a revised food frequency questionnaire that is
designed to capture vitamin D, calcium and protein intake in a population of elderly men and
women with fragility fractures. Protein, calcium and protein intake will be correlated with
biochemical measures and bone mineral density measured by DXA.

The purpose of this study is to validate a revised food frequency questionnaire that is
designed to capture vitamin D, calcium and protein intake in a population of elderly men and
women with fragility fractures. Protein, calcium and protein intake will be correlated with
biochemical measures and bone mineral density measured by DXA.

Eligibility Criteria) Forty-five eligible participants will be recruited from the endocrine
referrals for osteoporosis/fracture. They will be men and women, age >65 years with a
fragility fracture (defined as a fracture sustained after a fall from a standing height or
less). They will be English speaking. They will need to have the mental capacity to recall
events, (MMSE score ³24).11 They will need to have a telephone and the ability to answer
questions over a phone. They will not have secondary causes of fragility fracture such as
malabsorption (celiac disease, bariatric surgery), liver disease, organ transplant,
hyperparathyroidism, multiple myeloma, current cancer diagnosis, or alcoholism. They will not
have renal disease requiring dialysis (as the dietary requirement of these patients is quite
different from the general elderly population). They will not be on tubefeeds of any kind
(although supplemental food such as Ensure is allowed). Interventions and Evaluations) The
evaluations will include a history and physical exam, and a mini mental status exam. Two
telephone interviews will be conducted ~ 4 weeks apart during which the Block 2014
questionnaire will be given and the revised screener will be given. The order that the
questionnaires are given will be randomized. As part of the standard of care workup for
osteoporosis, a biochemical workup including 25-hydroxyvitamin D, comprehensive metabolic
profile, bone specific alkaline phosphatase (a bone remodeling marker), phosphorus and
transglutaminase IgA (to rule out celiac disease), and DXA scan for bone mineral density
(BMD) measurement will be done. The BMD by DXA and 25-hydroxyvitamin D will be correlated to
protein, calcium and vitamin D intake obtained by the Block 2014.

Inclusion Criteria:

- They will be men and women, age >65 years with a fragility fracture (defined as a
fracture sustained after a fall from a standing height or less). They will be English
speaking. They will need to have the mental capacity to recall events, (MMSE score
>24).11 They will need to have a telephone and the ability to answer questions over a
phone.

Exclusion Criteria:

- They will not have secondary causes of fragility fracture such as malabsorption
(celiac disease, bariatric surgery), liver disease, organ transplant,
hyperparathyroidism, multiple myeloma, current cancer diagnosis, or alcoholism. They
will not have renal disease requiring dialysis (as the dietary requirement of these
patients is quite different from the general elderly population). They will not be on
tubefeeds of any kind (although supplemental food such as Ensure is allowed).
We found this trial at
1
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Omaha, Nebraska 68198
Phone: 402-559-6310
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Omaha, NE
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