[Prevention of bone loss by estradiol valerate combined with medroxyprogesterone acetate among postmenopausal women with osteopenia].
OBJECTIVE
To observe the efficacy of estradiol valerate (E(2)V) combined with medroxyprogesterone acetate (MPA) in prevention of bone loss among postmenopausal women with osteopenia.


METHODS
Ninety-two women 1 to 8 years after menopause with osteopenia were randomly divided into 4 groups: 1) control group: 23 cases, taking calcium carbonate (Ca) 400 mg/d+ vitamin D 200 IU/D; 2) treatment group 1: 24 cases, taking E(2)V 1.0 mg/d+ MPA 2 mg/d+ Ca 400 mg/d; 3) treatment group 2: taking E(2)V 1.0 mg/d+ MPA 2 mg/d+ Ca 400 mg/d+ vitamin D 200 IU/d; and 4) treatment group 3: taking E(2)V 1.5 mg/d+ MPA 2 mg/d+ Ca 400 mg/d+ vitamin D 200 IU/d. The bone mineral density (BMD) of L(2- 4) and neck of femur was measured by DEXA method, and the bone metabolic markers such as serum alkaline phosphatase (ALP) and urine Ca/Cr and Ntx/Cr were examined just before the drug administration and 6, 12, and 18 months after the beginning of experiment. Vaginal bleeding and breast tenderness were recorded by the subjects themselves and examined by investigators.


RESULTS
Seventy-eight subjects (84.5%) were followed up for I year and 77 of them (83.7%) were followed up for 1.5 years. The fasting morning Ca/Cr remained almost unchanged in the control group, and decreased by 43.8%, 33.3%, and 33.3% by the third month respectively and then remained unchanged in the treatment groups 1, 2, and 3. The urine Ntx/Cr decreased mildly but insignificantly in the control group (P > 0.05), and decreased since the 3rd month by 42.2%, 53.2%, and 29.1% respectively in the treatment groups 1 approximately 3 and then decreased very slowly. The ALP remained almost unchanged in the control group, and decreased by 6.8%, 17.0%, and 16.4% by the 6th months respectively and by 14.2%, 17.9%, and 28.8% by the 12th month and then remained almost unchanged in the treatment groups 1 approximately 3. The BMD of L2-4 increased by 7.1% +/- 4.6%, 6.8% +/- 5.3%, and 9.0% +/- 4.0% in the treatment 1 approximately 3 by the 18th month. The BMD of neck of femur increased by 4.1% +/- 3.2%, 4.0% +/- 5.9%, and 5.9% +/- 4.8% in the treatment 1 approximately 3 by the 18th month. Fracture occurred in 2 cases of the control group and 2 cases of the treatment group because of accidents. The vaginal bleeding rate was the highest in the treatment group 3 (47.4%). The breast tenderness rates were 27.3% approximately 47.6% in the 3 treatment groups.


CONCLUSIONS
Administration of E(2)V I mg/d combined with MPA 2 mg/d is an optional regimen for postmenopausal women with intact uterine.
Lu
Junli
J
Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China.
Lin
Shouqing
S
Zhang
Lisong
L
Yu
Wei
W
Shen
Ying
Y
Zhang
Ying
Y
Chen
Fengling
F
D000328:Adult; D015519:Bone Density / Q000502:physiology; D001851:Bone Diseases, Metabolic / Q000150:complications* / Q000517:prevention & control; D004359:Drug Therapy, Combination; D004958:Estradiol / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000627:therapeutic use*; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000517:prevention & control*; D045167:Progesterone Congeners / Q000627:therapeutic use
D045167:Progesterone Congeners; D004958:Estradiol; D017258:Medroxyprogesterone Acetate