Effect of estrogen replacement plus low-dose alendronate treatment on bone density in surgically postmenopausal women with osteoporosis.
This prospective randomized, double-blind, placebo-controlled, clinical trial was performed to evaluate the effectiveness of estrogens plus low-dose alendronate on bone metabolism. A total of 150 surgically postmenopausal women with osteoporosis were randomized in three groups: group A, micronized E2 (2 mg/d) plus standard-dose alendronate (10 mg/d); group B, micronized E2 plus low-dose alendronate (5 mg/d); and group C, micronized E2 plus placebo (one tablet per day). In all women, bone mineral density (BMD) and serum bone metabolism markers were assessed at admission and every 6 months for 2 yr. After 2 yr, BMD significantly increased compared with baseline in all groups. The percentage BMD change was significantly higher in groups A and B than in group C. The differences in BMD detected between groups A and B were not statistically significant. Since the 6-month follow-up and throughout the study, serum osteocalcin and bone alkaline phosphatase levels and urinary deoxypyridinoline and pyrilinks-D excretion were significantly reduced in all groups. Serum bone alkaline phosphatase levels significantly decreased in groups A and B, without difference between them, in comparison with group C. In conclusion, in surgically postmenopausal osteoporotic women treated with estrogen replacement, the addition of alendronate at a low dose of 5 mg daily induces a gain of bone mass not significantly different in comparison with that obtained using a standard dose of 10 mg daily.
Palomba
Stefano
S
Obstetrics and Gynecology, University of Catanzaro, 88100 Catanzaro, Italy. stefanopalomba@tin.it
Orio
Francesco
F
Colao
Annamaria
A
di Carlo
Costantino
C
Sena
Teresa
T
Lombardi
Gaetano
G
Zullo
Fulvio
F
Mastrantonio
Pasquale
P
D019386:Alendronate / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015415:Biomarkers; D015519:Bone Density / Q000187:drug effects*; D001842:Bone and Bones / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D005260:Female; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000378:metabolism; D011446:Prospective Studies
D015415:Biomarkers; D019386:Alendronate