A framework tool for assessing the scientific support for claims relating to bone health and osteoporosis has been developed by a group working towards the European PASSCLAIM recommendations.
In this week's issue of the European Journal of Nutrition, different working groups report on recent progress made on the EC PASSCLAIM - the Process for the Assessment of Scientific Support of Claims on Foods - which aims to produce a generic tool for assessing the scientific support for health-related claims for foods and food components.
A working group, made up of experts from companies and institutions including ILSI Europe, University College of Cork, Roche and Procter and Gamble, evaluated the scientific evidence needed to support claims in relation to bone health and osteoporosis.
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. Taking osteoporotic fracture as the health endpoint, the framework concluded that 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.
Also, 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.
The framework also confirmed that 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.
Finally, 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, reported the working group.
The framework will contribute to the formulation under PASSCLAIM of a generic tool for assessing the scientific support of health claims on foods.