Prevention of postmenopausal bone loss with minimal uterine bleeding using low dose continuous estrogen/progestin therapy: a 2-year prospective study.
OBJECTIVE
To re-examine the minimal effective dose of conjugated estrogen (CEE)-progestin hormone replacement on postmenopausal bone loss.


METHODS
A 2-year, prospective, open label, randomized study.


METHODS
Department of Obstetrics and Gynecology of a university hospital.


METHODS
Fifty-two postmenopausal or oophorectomized women.


METHODS
One of the following regimens was continuously administered for 2 years: (1) CEE 0.625 mg/day, (2) CEE 0.625 mg + medroxyprogesterone (MPA) 2.5 mg/day, (3) CEE 0.31 mg + MPA 2.5 mg/day and (4) control.


METHODS
Lumbar spine and femoral BMD by dual energy X-ray absorptiometry (DXA), a monthly based incidence of bleeding, serum lipids, PTH, calcitonin. A1-p, and osteocalcin.


RESULTS
Of the 52 patients enrolled in this study, 49 patients completed the 1 year of therapy and 36 completed the 2- year study. The control group showed a significant decrease in lumbar BMD over the 2 years (P < 0.05). The % changes in lumbar BMD at 2 years of CEE alone, CEE 0.625 + MPA and CEE 0.31 + MPA were 8.52% (95% confidence intervals; 4.61 approximately 12.4%), 7.4% (0.60 approximately 14.2%) and 3.20% (0.61 approximately 5.84%), respectively, and were significantly higher than pretreatment values. The incidence of bleeding was significantly lower in women taking CEE 0.31 mg + MPA. HDL cholesterol increased in women taking CEE 0.625 mg alone or with MPA. No significant changes in lipid profiles were seen in the control or in the group of women taking CEE 0.31 mg + MPA.


CONCLUSIONS
Continuous hormone replacement therapy (HRT) using 0.31 mg of CEE and 2.5 mg of MPA is effective in increasing lumbar BMD in postmenopausal or oophorectomized women and can be an appropriate option for women with a normal lipid profile or those women wishing to eliminate unscheduled bleeding.
Mizunuma
H
H
Department of Obstetrics and Gynecology, Gunma University School of Medicine, Showa-machi, Maebashi, Japan.
Okano
H
H
Soda
M
M
Kagami
I
I
Miyamoto
S
S
Tokizawa
T
T
Honjo
S
S
Ibuki
Y
Y
D015519:Bone Density / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D015914:Estrogen Replacement Therapy; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008525:Medroxyprogesterone / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D045167:Progesterone Congeners / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D014592:Uterine Hemorrhage / Q000139:chemically induced / Q000517:prevention & control*
D004966:Estrogens, Conjugated (USP); D045167:Progesterone Congeners; D008525:Medroxyprogesterone