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PASSCLAIM - Bone health and osteoporosis

PASSCLAIM - Bone health and osteoporosis
PASSCLAIM - Bone health and osteoporosis
Summary. Background: The EC Concerted Action PASSCLAIM aims to produce a generic tool for assessing the scientific support for health-related claims for foods and food components. Aim: The task of the ITGB Working Group was to critically evaluate the categories of scientific evidence needed to support claims in relation to bone health and osteoporosis. Methods: A framework was developed to describe the chain of evidence that is required to link the consumption of a food or food component to bone health outcomes. Techniques available for interrogating each link in the chain were identified and their strengths and weaknesses considered. This framework was used to determine intermediate markers of health outcome with respect to osteoporosis and to debate the level of evidence that would be required to substantiate claims of enhanced function or reduced disease risk. Results: Use of this framework with osteoporotic fracture as the health endpoint resulted in the following judgements based on current knowledge: 1) bone mineral density (BMD) is an intermediate marker of bone health which, for people of any age and sex, can provide evidence of enhanced function; 2) for people over 50 years living in populations with a high incidence of fracture, BMD is an intermediate marker of osteoporotic fracture risk which can provide evidence of an increased probability of reduced disease risk; 3) because osteoporosis is defined as a state of increased fracture risk due to low bone mass and deterioration in bone microarchitecture, a claim of a definite reduction in osteoporosis or fracture risk requires similar substantiation to claims that fractures are prevented or treated, including clinical trials and animal studies; 4) data from lower in the chain of evidence, such as bone turnover and calcium bioavailability, are not, by themselves, sufficiently strongly related to bone health endpoints to provide evidence of enhanced function or reduced disease risk but can provide supporting information. Conclusions: In the light of existing scientific knowledge, a framework has been developed as a tool for considering the scientific support for claims relating to bone health and osteoporosis. To provide a working example, the framework has been used to assess the current position with osteoporotic fracture as the health endpoint. This experience will contribute to the formulation under PASSCLAIM of a generic tool for assessing the scientific support of health claims on foods.
bone health, bone mineral density, health claims, osteoporosis
1436-6207
I28-I49
Prentice, Anne
d4f64e9c-f9dd-4a22-9b6d-221faeaa0970
Bonjour, Jean-Philippe
f60e6fea-cde7-405a-ab89-7c5a376af380
Branca, Francesco
9fefd7b0-7427-418d-8f83-3f0a6b718255
Cooper, Cyrus
e05f5612-b493-4273-9b71-9e0ce32bdad6
Flynn, Albert
8c1424e3-214a-4e06-9354-37b282c18113
Garabedian, Michele
bc32be2c-5399-42ef-a7a5-315b10b77878
Muller, Detlef
7ad356d5-4b53-4160-af8c-8fdafb0c40b5
Pannemans, Daphne
85bc17b2-3b08-481a-899d-9738b6863c39
Weber, Peter
6bf5aa8f-1918-43ca-b80d-0dad50db9549
Prentice, Anne
d4f64e9c-f9dd-4a22-9b6d-221faeaa0970
Bonjour, Jean-Philippe
f60e6fea-cde7-405a-ab89-7c5a376af380
Branca, Francesco
9fefd7b0-7427-418d-8f83-3f0a6b718255
Cooper, Cyrus
e05f5612-b493-4273-9b71-9e0ce32bdad6
Flynn, Albert
8c1424e3-214a-4e06-9354-37b282c18113
Garabedian, Michele
bc32be2c-5399-42ef-a7a5-315b10b77878
Muller, Detlef
7ad356d5-4b53-4160-af8c-8fdafb0c40b5
Pannemans, Daphne
85bc17b2-3b08-481a-899d-9738b6863c39
Weber, Peter
6bf5aa8f-1918-43ca-b80d-0dad50db9549

Prentice, Anne, Bonjour, Jean-Philippe, Branca, Francesco, Cooper, Cyrus, Flynn, Albert, Garabedian, Michele, Muller, Detlef, Pannemans, Daphne and Weber, Peter (2003) PASSCLAIM - Bone health and osteoporosis. European Journal of Nutrition, 42 (supplement 1), I28-I49. (doi:10.1007/s00394-003-1103-1).

Record type: Article

Abstract

Summary. Background: The EC Concerted Action PASSCLAIM aims to produce a generic tool for assessing the scientific support for health-related claims for foods and food components. Aim: The task of the ITGB Working Group was to critically evaluate the categories of scientific evidence needed to support claims in relation to bone health and osteoporosis. Methods: A framework was developed to describe the chain of evidence that is required to link the consumption of a food or food component to bone health outcomes. Techniques available for interrogating each link in the chain were identified and their strengths and weaknesses considered. This framework was used to determine intermediate markers of health outcome with respect to osteoporosis and to debate the level of evidence that would be required to substantiate claims of enhanced function or reduced disease risk. Results: Use of this framework with osteoporotic fracture as the health endpoint resulted in the following judgements based on current knowledge: 1) bone mineral density (BMD) is an intermediate marker of bone health which, for people of any age and sex, can provide evidence of enhanced function; 2) for people over 50 years living in populations with a high incidence of fracture, BMD is an intermediate marker of osteoporotic fracture risk which can provide evidence of an increased probability of reduced disease risk; 3) because osteoporosis is defined as a state of increased fracture risk due to low bone mass and deterioration in bone microarchitecture, a claim of a definite reduction in osteoporosis or fracture risk requires similar substantiation to claims that fractures are prevented or treated, including clinical trials and animal studies; 4) data from lower in the chain of evidence, such as bone turnover and calcium bioavailability, are not, by themselves, sufficiently strongly related to bone health endpoints to provide evidence of enhanced function or reduced disease risk but can provide supporting information. Conclusions: In the light of existing scientific knowledge, a framework has been developed as a tool for considering the scientific support for claims relating to bone health and osteoporosis. To provide a working example, the framework has been used to assess the current position with osteoporotic fracture as the health endpoint. This experience will contribute to the formulation under PASSCLAIM of a generic tool for assessing the scientific support of health claims on foods.

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More information

Published date: March 2003
Keywords: bone health, bone mineral density, health claims, osteoporosis

Identifiers

Local EPrints ID: 25919
URI: http://eprints.soton.ac.uk/id/eprint/25919
ISSN: 1436-6207
PURE UUID: 051b56ec-9927-4472-875b-e0eb3796dcfe
ORCID for Cyrus Cooper: ORCID iD orcid.org/0000-0003-3510-0709

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Date deposited: 21 Apr 2006
Last modified: 18 Mar 2024 02:44

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Contributors

Author: Anne Prentice
Author: Jean-Philippe Bonjour
Author: Francesco Branca
Author: Cyrus Cooper ORCID iD
Author: Albert Flynn
Author: Michele Garabedian
Author: Detlef Muller
Author: Daphne Pannemans
Author: Peter Weber

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