Objectives: To evaluate whether introduction of treatment alternatives
would improve compliance with hormonal replacement therapy (HRT) as p
rimary osteoporosis prevention in women not tolerating the first line
osteoporosis prevention schedule. Material and methods: Follow-up in f
our hospitals participating in the Danish Osteoporosis Prevention Stud
y. A total of 706 peri-and postmenopausal women aged 45-57 years betwe
en 3 and 24 months from last menstrual bleeding took part, 489 women w
ere randomised to HRT and 217 received HRT by personal choice. A total
of. 135 (190/0) women were hysterectomised. HRT was given as oral or
transdermal oestradiol supplemented with progestogen. If the initial t
reatment allocation was not acceptable several alternatives were avail
able in a pragmatic approach. Results: Compliance with first treatment
schedule was lower in women with intact uterus (at 5 years: 48.3+/-2.
4% compliance) than in hysterectomised (64.7+/-5.8%, P<0.001 in a Cox
analysis) but did not differ after the introduction of HRT alternative
s (67.0+/-2.9 vs 77.8+/-5.9, P=0.12). Compliance decreased with increa
sing age at treatment start (RR=1.11, P<0.001) in women with intact ut
erus but not in hysterectomised women (P=0.96). Headache/migraine was
more frequent among women with intact uterus on oral sequential oestro
gen plus progestogen than among hysterectomised women receiving oral c
ontinuous oestrogen (RR=11.3, P<0.01). Conclusions: It seems possible
to maintain a high HRT compliance by a pragmatic approach including of
fering alternative HRT formulations to women not tolerating the primar
y HRT. Further research into long-term compliance with HRT and cost-be
nefit is warranted. (C) 1997 Elsevier Science Ireland Ltd.