REVIEW The need for clinical guidance in the use of calcium and vitamin D in the management of osteoporosis: a consensus report S. Boonen Æ R. Rizzoli Æ P.J. Meunier Æ M. Stone G. Nuki Æ U. Syversen Æ M. Lehtonen-Veromaa P. Lips Æ O. Johnell Æ J.-Y. Reginster Received: 3 October 2003 / Accepted: 24 February 2004 / Published online: 7 April 2004 Ó International Osteoporosis Foundation and National Osteoporosis Foundation 2004 Abstract A European Union (EU) directive on vitamins and minerals used as ingredients of food supplements with a nutritional or physiological effect (2002/46/EC) was introduced in 2003. Its implications for the use of oral supplements of calcium and vitamin D in the pre- vention and treatment of osteoporosis were discussed at a meeting organized with the help of the World Health Organization (WHO) Collaborating Center for Public Health Aspects of Rheumatic Diseases (Lie` ge, Belgium) and the support of the WHO Collaborating Center for Osteoporosis Prevention (Geneva, Switzerland). The following issues were addressed: Is osteoporosis a physiological or a medical condition? What is the evi- dence for the efficacy of calcium and vitamin D in the management of postmenopausal osteoporosis? What are the risks of self-management by patients in osteoporosis? From their discussions, the panel concluded that: (1) osteoporosis is a disease that requires continuing medi- cal attention to ensure optimal therapeutic benefits; (2) when given in appropriate doses, calcium and vitamin D have been shown to be pharmacologically active (par- ticularly in patients with dietary deficiencies), safe, and effective for the prevention and treatment of osteopo- rotic fractures; (3) calcium and vitamin D are an essential, but not sufficient, component of an integrated management strategy for the prevention and treatment of osteoporosis in patients with dietary insufficiencies, although maximal benefit in terms of fracture prevention requires the addition of antiresorptive therapy; (4) cal- cium and vitamin D are a cost-effective medication in the prevention and treatment of osteoporosis; (5) it is apparent that awareness of the efficacy of calcium and vitamin D in osteoporosis is still low and further work needs to be done to increase awareness among physi- cians, patients, and women at risk; and (6) in order that calcium and vitamin D continues to be manufactured to Good Manufacturing Practice standards and physicians and other health care professionals continue to provide guidance for the optimal use of these agents, they should continue to be classified as medicinal products. Keywords Calcium Æ Fracture prevention Æ Osteoporosis drugs Æ Vitamin D Introduction European Union (EU) Directive 2002/46/EC on vita- mins and minerals used as ingredients of food supple- ments with a nutritional or physiological effect [1] was introduced in 2003. An international expert panel dis- cussed its implications for the use of oral supplements of calcium and vitamin D in the prevention and treatment of osteoporosis at a meeting in Barcelona on 10 November 2002. This meeting was organized with the help of the World Health Organization (WHO) Osteoporos Int (2004) 15: 511–519 DOI 10.1007/s00198-004-1621-6 S. Boonen (&) Æ J. Reginster Leuven University Centre for Metabolic Bone Diseases & Division of Geriatric Medicine, University Hospital Leuven, Herestraat 49, B-3000 Leuven, Belgium E-mail: steven.boonen@uz.kuleuven.ac.be Tel.: +32-16-344824 Fax: +32-16-344402 R. Rizzoli University Hospital, Geneva, Switzerland P.J. Meunier Hoˆpital Edouard Herriot, Lyon, France M. Stone Llandough Hospital, Penarth, UK G. Nuki University of Edinburgh, Edinburgh, UK U. Syversen St Olavs Hospital HF, Trondheim, Norway M. Lehtonen-Veromaa University of Turku, Turku, Finland P. Lips VU Medical Centre, Amsterdam, The Netherlands O. Johnell Malmo¨ Hospital, University of Malmo¨, Malmo¨, Sweden J.-Y. Reginster Unite´ d’Exploration de l’Os et du Cartilage, Lie`ge, Belgium