Low doses of estradiol in combination with gestodene to prevent early postmenopausal bone loss.
OBJECTIVE
Our purpose was to study combinations of estradiol and gestodene for prevention of bone loss in early postmenopausal women.


METHODS
We randomly assigned 278 healthy, early postmenopausal women to receive either 2 mg 17beta-estradiol sequentially combined with 25 microg gestodene (group 2/25s), 2 mg estradiol sequentially combined with 50 microg gestodene (group 2/50s), 1 mg estradiol sequentially combined with 25 microg gestodene (group 1/25s), 1 mg estradiol continuously combined with 25 mg gestodene (group 1/25c), or placebo.


RESULTS
After 3 years the changes in bone mineral density of the spine were as follows (mean +/- SEM): group 2/25s, 7. 41% +/- 0.72%; group 2/50s, 8.53% +/- 0.90%; group 1.25s, 6.67% +/- 0.88%; group 1/25c, 4.44% +/- 0.59%; and placebo group, -2.03% +/- 0. 64%. The changes in bone mineral density were mirrored in the biochemical bone markers. The average responses for the urinary C-terminal telopeptide fragments of type I collagen corrected for creatinine excretion were as follows (mean of baseline +/- SEM): group 2/25s, -68.8% +/- 0.03%; group 2/50s, -72.8% +/- 0.02%; group 1/25s, -60.7% +/- 0.03%; group 1/25c, -52.28% +/- 0.04%; and placebo group, 6.5% +/- 0.09%. Beneficial lipid effects were found in all active groups. The decreases in low-density lipoprotein were as follows (mean +/- SEM): group 2/25s, -13.7% +/- 3.0%; group 2/50s, -14.6% +/- 3.2%; group 1/25s, -9.28% +/- 2.2%; group 1/25c, -9.92% +/- 2.4%; and placebo group, 1.53% +/- 1.9%.


CONCLUSIONS
These results demonstrate that estradiol therapy with 1 mg estradiol is fully protective against early postmenopausal bone loss.
Bjarnason
N H
NH
Center for Clinical and Basic Research, Ballerup, Denmark.
Byrjalsen
I
I
Hassager
C
C
Haarbo
J
J
Christiansen
C
C
D015519:Bone Density; D002979:Climacteric; D003094:Collagen / Q000652:urine; D024042:Collagen Type I; D003404:Creatinine / Q000652:urine; D004958:Estradiol / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D004970:Estrone / Q000097:blood; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D008055:Lipids / Q000097:blood; D008077:Lipoproteins, LDL / Q000097:blood; D008875:Middle Aged; D009652:Norpregnenes / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D010455:Peptides / Q000652:urine; D010919:Placebos; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D013131:Spine
D024042:Collagen Type I; D008055:Lipids; D008077:Lipoproteins, LDL; D009652:Norpregnenes; D010455:Peptides; D010919:Placebos; D045167:Progesterone Congeners; C052929:collagen type I trimeric cross-linked peptide; C033273:Gestodene; D004970:Estrone; D004958:Estradiol; D005640:Follicle Stimulating Hormone; D003094:Collagen; D003404:Creatinine