UNLABELLED: The author investigated postmenopausal patients (with a natural menopause) (n = 32) where ammenorrhoea persisted for 1-2.2 years. They found a reduced bone mineral density (BMD) (ostoeopenia or osteoporosis) and laboratory tests revealed signs of increased bone turnover (so-called "fast losers"). Before administration of Kliogest R tablets, Novo Nordisk, Denmark, (1 tablet per day) and after 12 months the following parameters were evaluated: 1. Laboratory parameters of bone turnover: serum osteocalcin (OC) amino-terminal N-telopeptide of collagen I in 24-hour diuresis (NTx). 2. Bone mineral desnity (BMD) in lumbal vertebrae L1-L4 assessed by DXA (dual energy X-ray absorptiometry 3. By means of questionnaires climacteric symptoms were evaluated (score of climacteric symptoms). For statistical analysis of the assessed values the non-paired Wilcoxon-Wilcoxon test was used.

RESULTS: After treatment the OC levels were significantly lower (alpha = 0.05, p < 0.01), the values of NTx were highly significantly lower (alpha = 0.05, p < 0.001) and the BMD values in the second lumbar vertebra (it is usually most affected by osteoporosis), expressed by the T-score, was significantly higher (alpha = 0.05, p < 0.001). When evaluating the questionnaire "Score of climacteric symptoms" after treatment the number of points characterizing the intensity of symptoms was reduced. Most frequently improvement of the following symptoms was achieved: hot flushes and noctural perspiration, weakness, fatigue, impaired sleep, nervousness, irritability, dry vagina making intercourse unpleasant.

CONCLUSION: One-year use of Kliogest increased significantly the density of the bone mineral in the axial skeleton, reduced the bone turnover and improved the quality of life of postmenopausal patients.

Keywords: Bone Density /drug effects/; Bone and Bones /metabolism/; Climacteric /drug effects/; Collagen /metabolism/; Collagen Type I; Drug Combinations; Estradiol /pharmacology/; Estriol /pharmacology/; Estrogen Replacement Therapy; Female; Humans; Middle Aged; Norethindrone /analogs & derivatives/; Osteocalcin /metabolism/; Peptides /metabolism/; Quality of Life