Effect of low-dose transdermal E2/NETA on the reduction of postmenopausal bone loss in women

Alessandro Rubinacci, Elena Peruzzi, Alberto Bacchi Modena, Ettore Zanardi, Bruno Andrei, Vincenzo De Leo, Francesco Saverio Pansini, Erhard Quebe-Fehling, Patricia Ibarra De Palacios

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Objective: To assess the efficacy of a continuous-combined transdermal patch (estradiol/norethisterone acetate [E2/NETA] 25/125; Estragest TTS, Novartis, Basel, Switzerland) in the reduction of bone loss in postmenopausal women. Design: In a 96-week, double-blind, randomized, multicenter, parallel study, 124 healthy women with an intact uterus more than 4 years after menopause received either transdermal continuous-combined E2/NETA (0.025/0.125 mg/day) or placebo patch for 24 treatment cycles; diet was normalized for calcium intake. Lumbar spine bone mineral density (BMD) ranged from 0.969 to 0.805 g/cm2 with a mean annual BMD decrement ranging from 3% to 8% within the last 24 months. BMD at lumbar spine L2-L4 (postero-anterior) and femur were assessed by dual energy x-ray absorptiometry after 6, 12, and 24 cycles. Efficacy variables included measurement of biochemical markers of bone turnover (3, 6, 12, and 24 months). Results: BMD at lumbar spine was significantly higher at all time points in the E2/NETA group than in the placebo group (P <0.0001). Significant increases in BMD (P <0.0008) from baseline were observed at all sites after 24 months in the E2/NETA group compared with placebo, which demonstrated a decrease from baseline. At endpoint, statistically significant decrements in the values of bone remodeling markers were observed (P <0.05) with E2/NETA. Conclusions: E2/NETA 25/125 Estragest TTS was more effective than placebo in reducing the activation frequency of bone remodeling and in preventing bone loss at the spine and hip. Effects on the hip were similar to those observed for higher doses of estrogen.

Original languageEnglish
Pages (from-to)241-249
Number of pages9
JournalMenopause
Volume10
Issue number3
DOIs
Publication statusPublished - May 2003

Fingerprint

Postmenopausal Osteoporosis
Bone Density
Bone Remodeling
Spine
Placebos
Hip
Transdermal Patch
Menopause
Switzerland
Femur
Multicenter Studies
Uterus
Estradiol
Estrogens
Biomarkers
X-Rays
Diet
Calcium
Bone and Bones

Keywords

  • Bone loss
  • Estradiol
  • Estrogen replacement therapy
  • Postmenopausal women
  • Transdermal delivery

ASJC Scopus subject areas

  • Obstetrics and Gynaecology

Cite this

Rubinacci, A., Peruzzi, E., Modena, A. B., Zanardi, E., Andrei, B., De Leo, V., ... De Palacios, P. I. (2003). Effect of low-dose transdermal E2/NETA on the reduction of postmenopausal bone loss in women. Menopause, 10(3), 241-249. https://doi.org/10.1097/00042192-200310030-00012

Effect of low-dose transdermal E2/NETA on the reduction of postmenopausal bone loss in women. / Rubinacci, Alessandro; Peruzzi, Elena; Modena, Alberto Bacchi; Zanardi, Ettore; Andrei, Bruno; De Leo, Vincenzo; Pansini, Francesco Saverio; Quebe-Fehling, Erhard; De Palacios, Patricia Ibarra.

In: Menopause, Vol. 10, No. 3, 05.2003, p. 241-249.

Research output: Contribution to journalArticle

Rubinacci, A, Peruzzi, E, Modena, AB, Zanardi, E, Andrei, B, De Leo, V, Pansini, FS, Quebe-Fehling, E & De Palacios, PI 2003, 'Effect of low-dose transdermal E2/NETA on the reduction of postmenopausal bone loss in women', Menopause, vol. 10, no. 3, pp. 241-249. https://doi.org/10.1097/00042192-200310030-00012
Rubinacci, Alessandro ; Peruzzi, Elena ; Modena, Alberto Bacchi ; Zanardi, Ettore ; Andrei, Bruno ; De Leo, Vincenzo ; Pansini, Francesco Saverio ; Quebe-Fehling, Erhard ; De Palacios, Patricia Ibarra. / Effect of low-dose transdermal E2/NETA on the reduction of postmenopausal bone loss in women. In: Menopause. 2003 ; Vol. 10, No. 3. pp. 241-249.
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abstract = "Objective: To assess the efficacy of a continuous-combined transdermal patch (estradiol/norethisterone acetate [E2/NETA] 25/125; Estragest TTS, Novartis, Basel, Switzerland) in the reduction of bone loss in postmenopausal women. Design: In a 96-week, double-blind, randomized, multicenter, parallel study, 124 healthy women with an intact uterus more than 4 years after menopause received either transdermal continuous-combined E2/NETA (0.025/0.125 mg/day) or placebo patch for 24 treatment cycles; diet was normalized for calcium intake. Lumbar spine bone mineral density (BMD) ranged from 0.969 to 0.805 g/cm2 with a mean annual BMD decrement ranging from 3{\%} to 8{\%} within the last 24 months. BMD at lumbar spine L2-L4 (postero-anterior) and femur were assessed by dual energy x-ray absorptiometry after 6, 12, and 24 cycles. Efficacy variables included measurement of biochemical markers of bone turnover (3, 6, 12, and 24 months). Results: BMD at lumbar spine was significantly higher at all time points in the E2/NETA group than in the placebo group (P <0.0001). Significant increases in BMD (P <0.0008) from baseline were observed at all sites after 24 months in the E2/NETA group compared with placebo, which demonstrated a decrease from baseline. At endpoint, statistically significant decrements in the values of bone remodeling markers were observed (P <0.05) with E2/NETA. Conclusions: E2/NETA 25/125 Estragest TTS was more effective than placebo in reducing the activation frequency of bone remodeling and in preventing bone loss at the spine and hip. Effects on the hip were similar to those observed for higher doses of estrogen.",
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AU - Andrei, Bruno

AU - De Leo, Vincenzo

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