The Long-term Effect on Bone Markers (BM) and Body Mineral Density (BMD) of Daily Jarlsberg Cheese Intake in Patient With Osteopenia

Aim: To estimate the short- and long-term effect of daily optimal efficacy dose (OED) of Jarlsberg cheese on BMD, bone turn-over markers (BTMs) and Osteocalcin in patients with Osteopeni (OP).

Study population: The study population consists of OP-patients of post-menopausal women and men above 55 years of age who had a daily OED intake of Jarlsberg Cheese 32 weeks prior to inclusion in the study. OP patients are defined as patients with a T-score below 0.0 but larger than -2.5.

Trial treatment: The optimal daily intake of Jarlsberg cheese depending on gender, age, and physical activity. Women in post-menopausal age have a daily OED Jarlsberg of 47gram and men in above 55 years of age have an estimated daily OED of 71gram.The cheese will be delivered in package of 250 gram with slices average of 15.625gram. 47 gram represents 3 slices and 67 gram 4.5 slices. In addition to Jarlsberg Cheese, all the included patients will receive 40mcg vitamin D and 500 mg Ca.

Design: The study will be performed as a follow-up study of a randomized, single-blinded Norwegian multicentre trial with stratified semi-cross-over design with gender and participating General Practitioner (GP) site as stratification factors. GP's from Viken county will participate. This follow-up part will be performed as an open and one-armed observational study.

Main variables: The main response variable will be the change in Bone Mineral Density (BMD) and recorded at baseline follow-up after 32 weeks with daily Jarlsberg intake and the end of the follow-up study (Week 52). The second main variables will be total Osteocalcin (tOC), carboxylated osteocalcin (cOC), the osteocalcin ratio RO defined as the ratio between cOC and under-carboxylated osteocalcin (ucOC) [RO = cOC / ucOC] recorded at baseline-FU, week 26 and week 52. Additionally, the bone turnover markers (BTMs) cross-linked C-telopeptide type I collagen (CTX), procollagen type 1 N-terminal propeptide (PINP), bone specific ALP (BALB) and Parathyroid hormone (PTH) will be measured at the same visits. At baseline-FU and week 52, the following variables will be measured: Vitamin K2 and the different vitamers MK-7, MK-8, MK-9, and MK-9(4H) used as explanatory variable, Diet registration as controlling variables and HbA1C, Lipids, biochemical variables together with "Quality-of-Life" (QoL) questionnaire as supporting variables. The Interleukins IL-1β, IL6, IL8, IL10 and the Cytokines TNF-α, NF-ƙβ (RANK-L), OPG and TGF-β will be measured at baseline-FU and at the last visit in the study (Week 52). The Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) will be used for registration of Adverse Events (AE) and toxicity score at all investigation visits.