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Ultra-Low Dose Menostar (Estradiol Transdermal System) Increases Bone Mineral Density: Presented at NAMS

By Paula Moyer

SAN DIEGO, CA -- October 6, 2005 -- Transdermal 17-beta estradiol (Menostar), given at a dose of 14 mcg daily, increases lumbar spine and hip bone mineral density (BMD), according to investigators who presented their findings here September 29^th at the 16^th annual meeting of the North American Menopause Society (NAMS).

"Our data show that [this combination] can increase bone density at the lumbar spine and the hip," said principal investigator Laslo B. Tanko. MD, PhD, in an interview. The results were comparable to the results typically seen with higher doses of supplemental estrogen, he said. "We can reasonably speculate that this treatment offers some fracture protection." Dr. Tanko is a Senior Research Physician, Center for Clinical and Basic Research, Copenhagen, Denmark, which analyzed the data.

In this trial, the investigators recruited 417 postmenopausal women who were 60 to 80 years old with an intact uterus. The researchers randomized 208 women to the study drug and 209 to placebo. The goal of the study was to see if the efficacy and tolerability of treatment for the prevention of postmenopausal osteoporosis after 24 months of treatment.

In addition, all subjects received 800 mg of supplemental calcium and 400 IU of vitamin D daily. The investigators obtained baseline lumbar spine and total hip BMD measurements as well as biomarkers of bone turnover at baseline and 24 months, and endometrial thickness.

By the end of the study, the investigators observed significant increases over baseline in spine and hip BMD and decreases in biomarkers of bone turnover in the treated group compared to placebo. The differences on all parameters were strongly significant (P < .001), the investigators reported.

They also noted that the increases in spine BMD were independent of both initial BMD and presence of baseline osteoporosis risk factors.

Serious adverse events occurred in 24 in the treatment group and 23 in the placebo group. In each group, 10% of the patients discontinued due to an adverse event.

The most common adverse events typically associated with Menostar are upper respiratory infection, accidental injury, joint pain, leukorrhea, and application site reaction. These occurred at similar rates in the treatment and placebo groups.

Menostar is manufactured by Berlex, which funded the study.


[Presentation title: Menostar(TM), a Novel Ultra-Low Dose Transdermal Estradiol System: Effects on Bone Markers and BMD. Abstract S-2]

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