The effect of transvaginal estradiol on bone in aged women: a randomised controlled trial.
OBJECTIVE
To investigate the effect of transvaginal estradiol on bone mineral density and bone metabolism.


METHODS
One hundred and fifteen women (mean age 73.8+/-3.2 years) were randomly assigned to a 2-year open-label parallel group clinical trial and were treated with either transvaginal estradiol (7.5 microg/24h), or no estradiol. Both groups received 400 IU vitamin D and 500 mg calcium/day. The bone mineral density (BMD) was assessed in the hip and spine using DXA technique and in the heel using DXL technique.


RESULTS
The intention to treat analysis showed that the increase in BMD in the estradiol group was significant at total hip by 0.6% (P=0.04) while the control group decreased in their BMD by 0.7%. At lumbar spine the estradiol group increased in BMD by 2.6% (P=0.011) while the control group increased by 2.2%. Bone turnover markers and PTH-levels decreased while 25-OH vitamin D levels increased in both groups, a probable effect of the calcium and vitamin D supplementation. The bone resorption marker CTx decreased more significantly in the treatment group (P=0.016).


CONCLUSIONS
The transvaginal estradiol treatment of 7.5 microg/24h had a small but significant effect on the BMD of total hip and lumbar spine after a follow-up of 2 years.
Salminen
Helena S
HS
Centre for Family and Community Medicine, Karolinska Institutet, Stockholm, Sweden. helena.salminen@ki.se
Sääf
Maria E
ME
Johansson
Sven-Erik
SE
Ringertz
Hans
H
Strender
Lars-Erik
LE
D015502:Absorptiometry, Photon; D000282:Administration, Intravaginal; D000368:Aged; D000375:Aging / Q000378:metabolism*; D015519:Bone Density / Q000187:drug effects*; D001842:Bone and Bones / Q000187:drug effects* / Q000378:metabolism; D002118:Calcium / Q000378:metabolism; D004305:Dose-Response Relationship, Drug; D004958:Estradiol / Q000008:administration & dosage / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood; D008159:Lumbar Vertebrae / Q000187:drug effects / Q000378:metabolism; D010024:Osteoporosis / Q000378:metabolism / Q000517:prevention & control; D010384:Pelvic Bones / Q000187:drug effects / Q000378:metabolism; D014807:Vitamin D / Q000378:metabolism
D008055:Lipids; D014807:Vitamin D; D004958:Estradiol; D002118:Calcium