Objective: C-reactive protein and soluble E-selectin hold promise as surrogate markers for future cardiovascular events. We studied the effects of oral hormone therapy (HT) and alendronate, given alone or together, on these markers and on sex hormone-binding globulin levels in osteoporotic elderly women.
Design: Prospective, randomized, double-dummy trial.
Setting: Outpatient department of a university hospital.
Participant(s): Ninety osteoporotic women (T score < or =2.5 at the lumbar spine or femoral neck) 65 to 80 years of age.
Intervention(s): Randomized assignment to 1 year of treatment with estradiol, 2 mg p.o., plus norethisterone acetate, 1 mg (hormone therapy); alendronate, 10 mg; or HT plus alendronate.
Main outcome measure(s): Serum levels of C-reactive protein, E-selectin, and sex hormone-binding globulin were measured at baseline, 6 months, and 12 months.
Result(s): Hormone therapy significantly increased C-reactive protein levels by 76.5% at 6 months and by 47.1% at 12 months, but reduced E-selectin levels by 24.3% at 6 months and by 30.0% at 12 months. Alendronate had no effect on C-reactive protein or E-selectin and failed to modify the responses of C-reactive protein or E-selectin to hormone therapy. Hormone therapy increased sex hormone-binding globulin levels, whereas alendronate had no effect on this substance.
Conclusion(s): The increase in C-reactive protein level in response to oral HT in elderly osteoporotic women may result from stimulated synthesis of C-reactive protein in the liver, whereas the decrease in E-selectin level may reflect a direct effect of HT on endothelial cells. Alendronate has no effect on vascular markers or sex hormone-binding globulin.