Prevention of knee osteoarthritis - full scale trial
Projectomschrijving
Veel ouderen in Nederland hebben artrose in één of beide knieën (slijtage). Overgewicht blijkt volgens onderzoeken de grootste beïnvloedbare risicofactor voor deze aandoening. Dit project onderzoekt de werking van twee preventieve behandelingen voor knieartrose: afvallen en het innemen van een voedingssupplement. Ruim 400 vrouwen van middelbare leeftijd, met overgewicht en zonder knieklachten, doen mee aan het onderzoek. De helft van de deelnemende vrouwen krijgt een afvalprogramma aangeboden (dieet en bewegen) en de andere helft niet. Daarnaast wordt de werking van glucosaminesultaat (een voedingssupplement voor soepele gewrichten) getest. In beide groepen neemt de helft van de vrouwen dagelijks glucosaminesulfaat in en de andere helft een placebo (niet-werkzame stof). Na 2,5 jaar wordt gekeken of de behandelingen knieartrose (of de eerste tekenen daarvan) kunnen voorkomen.
Verslagen
Samenvatting van de aanvraag
The past decades, world wide research identified the major risk factors for developing osteoarthritis (OA) of the knee. The next important step in osteoarthritis research, also based on recent developments on intermediate outcome measures in OA, is to test preventive strategies in high-risk groups
Overweight is the major modifiable risk factor in knee OA. Overweight most often is caused by an unbalanced food intake in relation to physical activity, a way of life which is hard to change. To accomplish any change in such behavior, a "tailor made" intervention with diet and physical activity is the most successful. However, an intervention with oral crystalline glucosamine sulphate, a product with growing scientific evidence for its chondroprotective actions, is probably much more easy and feasible then the above-mentioned intervention.
In this full scale randomized intervention study we will test the preventive effect of both interventions. The study population will comprise a high-risk group for knee OA of 400 overweight women aged 50-60 years who not yet have consulted for pain in the knee. In a randomized controlled trial with factorial design half of the women will be randomized to the tailor made intervention to reduce weight, the other half will not receive this intervention. Secondly, in both groups half of them will be randomized to receive oral crystalline glucosamine sulphate while the other half will receive a placebo. Both groups will be followed for two and a half years. The primary outcome measure after two and a half years is the difference between the intervention and control groups in occurrence of radiological knee osteoarthritis (Kellgren & Lawrence index 2 or more), and/or joint space narrowing of 1 mm or more in one of the knees during the follow-up time, and/or occurrence of a knee osteoarthritis according to the ACR criteria.
Because OA is a gradually ongoing process and radiological OA features only are late derivatives of the processes in the joint, we will also measure intermediate outcomes (osteoarthrotic features measured on MRI, bone and collagen markers), giving a more direct insight in ongoing processes in and around the joint.