Prevention of postmenopausal bone loss by pulsed estrogen therapy: comparison with transdermal route

Pierre D. Delmas a,∗ , Longin Marianowski b , Antonio de Castro Perez c ,
Claude Ribot d , Bruno Pornel e , Santiago Palacios f , Patrice Lopes,
the Aerodiol study group1
a
INSERM Research Unit 403 and Claude Bernard University, Pavillon F, Hopital E. Herriot, 69437 Lyon, cedex France
b
Clinic of Gynaecology and Obstetrics, Warsaw, Poland
c
Hospital La Paz, Madrid, Spain
d
Rangueil Hospital, Toulouse, France
e
Brussels Menopause Center, Bruxelles, Belgium
f
Palacios Institute, Madrid, Spain
g
Women and Children’s Hospital, Nantes, France
Received 10 April 2003 ; received in revised form 10 December 2003 ; accepted 23 January 2004

Abstract
Objective: To compare the efficacy of pulsed estrogen therapy following intranasal 17-estradiol (E2) (S21400) with patch E2
in preventing postmenopausal bone loss and on bone turnover. Methods: In this multinational open study, 361 postmenopausal
women aged 51.5 (S.D. 4.6) years were treated with S21400 300 g per day or patch E2 (delivering 50 g per day), two patches
per week, for 56 weeks. Bone mineral density (BMD) was assessed at the spine and hip using dual X-ray absorptiometry at baseline
and week 56 (W56). Bone turnover markers (osteocalcin, bone alkaline phosphatase, urinary type I collagen C-telopeptides)
were measured at baseline and weeks 12, 28 and 56. Results: Spine and hip bone mineral density significantly increased in both
groups (P < 0.001 versus baseline). Mean (S.D.) percent increases were 2.1 (3.0) at the spine (both groups), and 1.2 (2.4) and
1.1 (2.2) at the hip in the S21400 and patch E2 groups, respectively. Bone mineral density also significantly increased (P < 0.001
versus baseline) in osteopenic patients following S21400 and patch E2: 3.1 (3.5) and 2.4 (3.5) at the spine, and 2.0 (2.6) and
1.2 (2.7) at the hip, respectively. Bone metabolism was normalized at week 56 with a significant decrease (P < 0.001) from
baseline in all markers: 56% and 53% for type I collagen C-telopeptides, and 24% and 25% for osteocalcin in the S21400 and patch E2 groups, respectively. Conclusion: Pulsed estrogen therapy was as effective in normalizing bone turnover and preventing
postmenopausal bone loss as a reservoir patch.
© 2004 Elsevier Ireland Ltd. All rights reserved.
Keywords: Postmenopausal; Estrogen therapy; Bone loss