Dm. Hart et al., Long-term effects of continuous combined HRT on bone turnover and lipid metabolism in postmenopausal women, OSTEOPOR IN, 8(4), 1998, pp. 326-332
This study was undertaken to investigate the effect of 10 years of hormone
replacement therapy (HRT) on bone turnover and lipid metabolism in postmeno
pausal women. The single-centre trial was initiated as a 1-year, double-mas
ked, randomized, parallel-group study of continuous combined HRT with 2 mg
17 beta-estradiol and 1 mg norethisterone acetate administered once daily w
ith or without 1 mg estriol. Following preliminary results which showed no
difference between the addition and omission of estriol, patients continued
on an open-label extension phase of continuous combined HRT without estrio
l for a further 9 years. Of the 52 women who entered the original double-ma
sked study, 32 entered the open-label extension phase. The 10-year analysis
was based on 27 patients. Major increases in bone mineral density (BMD) of
the lumbar spine were seen during the first 3 years of treatment, remainin
g statistically significant compared with baseline at all visits throughout
the 10-year followup (p less than or equal to 0.025). Statistical modellin
g confirmed that there were no decreases in BMD after these initial increas
es. BMD remained 5.5% higher than baseline values after 10 years of continu
ous combined HRT, Mean total cholesterol levels were significantly reduced
after 10 years of therapy (p = 0.012), with no significant changes in serum
triglyceride and low-density lipoprotein (LDL)-cholesterol levels from bas
eline values at this time. High-density lipoprotein (HDL)-cholesterol level
s, however, were reduced by 15.4% (p < 0.001). In conclusion, 10 years of c
ontinuous combined HRT resulted in a significant and sustained increase in
BMD. This treatment regimen therefore appears to be well suited for the lon
g-term prevention of osteoporosis in postmenopausal women.