A clinical trial of 3 doses of transdermal 17beta-estradiol for preventing postmenopausal bone loss: a preliminary study.
BACKGROUND
It is well documented that a daily oral dose of 0.625 mg of conjugated equine estrogen or 1-2 mg of 17beta-estradiol is needed to prevent postmenopausal bone loss. Recent studies have indicated that a lower dose of estrogen maybe as effective in maintaining bone mass. The purpose of this study was to evaluate the effects of 3 dosages of transdermally administered 17beta-estradiol gel in postmenopausal women stratified by oophorectomy and natural menopause.


METHODS
One hundred and twenty postmenopausal women were randomly selected to form 4 groups. Three groups of women were treated with a transdermal administration of estradiol gel at a daily dosage of 1.25, 2.5 and 5.0 g (containing 0.75, 1.5, and 3 mg of 17beta-estradiol/day), respectively. The 4th group of women, receiving estriol 2 mg/day p.o., was studied concurrently as a control. Bone mineral density was measured by quantitative computed tomography of the vertebrae from T12 to L3 at baseline, then at 6-month intervals for 1 year.


RESULTS
Women in all groups receiving 17beta-estradiol gel obtained a significant increase in bone mass, with the exception of the 1.25 g/day group, which showed a minimal increment at the 6-month period, compared with the control group. Comparisons of the increments in bone mass after estrogen therapy for both natural and surgical menopausal subjects found that there was a more prominent response in surgical menopausal women receiving a dosage of 2.5 g/day.


CONCLUSIONS
Estradiol gel at the dosage of 1.25 g/day, equivalent to 17beta-estradiol 0.75 mg/day, effectively prevented bone loss in postmenopausal women after a 12-month treatment period. The therapeutic effect of estradiol gel on bone mass was more prominent in the surgical menopausal groups at the dosage of 2.5 g/day. The atrophic ovaries may therefore play a crucial role in the subsequent decades of postmenopausal women.
Yang
Tzay-Shing
TS
Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, and National Yang-Ming University School of Medicine, Taipei, Taiwan, ROC. tsyang@vghtpe.gov.tw
Chen
Yi-Jen
YJ
Liang
Wei-Hsing
WH
Chang
Cheng-Yen
CY
Tai
Ling-Chen
LC
Chang
Sheng-Pin
SP
Ng
Heung-Tat
HT
D000279:Administration, Cutaneous; D015519:Bone Density; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D011446:Prospective Studies; D014057:Tomography, X-Ray Computed
D004958:Estradiol