Pulsed estrogen therapy in prevention of postmenopausal osteoporosis. A 2-year randomized, double blind, placebo-controlled study.

Therese F Nielsen, Pernille Ravn, Yu Z Bagger, Lise Warming, Claus Christiansen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Udgivelsesdato: 2004-Feb
OriginalsprogEngelsk
TidsskriftOsteoporosis International
Vol/bind15
Udgave nummer2
Sider (fra-til)168-74
Antal sider6
ISSN0937-941X
DOI
StatusUdgivet - 1. feb. 2004

Fingeraftryk

Postmenopausal Osteoporosis
Estrogens
Placebos
Femur Neck
Osteocalcin
Hip
Menopause
Osteogenesis
Uterus
Serum

Citer dette

@article{5d008ac06c6b11ddb1a1000ea68e967b,
title = "Pulsed estrogen therapy in prevention of postmenopausal osteoporosis. A 2-year randomized, double blind, placebo-controlled study.",
abstract = "The aim of this study was to evaluate the efficacy of pulsed estrogen therapy (intranasal 17beta-estradiol) in the prevention of postmenopausal bone loss. A total of 386 women (40-65 years old), less than 5 years past menopause, were randomized to intranasal placebo, 17beta-estradiol 150 micro g, or 300 micro g daily for 2 years. Women with an intact uterus received micronised progesterone 200 mg per day, 14 days of each 28-day cycle. Women randomised to placebo-treatment received placebo progesterone. The primary endpoints were changes in BMD at the spine (L2-L4) and femoral neck. Secondary endpoints were changes in bone turnover markers: serum osteocalcin (sOC) as a marker of bone formation and urinary C-terminal telopeptides (uCTX) as a marker of bone resorption. BMD increased at all measured sites in women receiving active treatment in a dose-related manner, the difference compared to placebo being 5.2{\%} and 6.7{\%} at the spine, and 3.2{\%} and 4.7 {\%} at the hip, respectively, with 150 microg and 300 microg ( P<0.001). On the other hand, a decrease versus baseline of -3.2{\%} and -3.3{\%} at the spine and hip, respectively, was observed in women receiving placebo ( P<0.001). In the patients with at least one risk factor for osteoporotic fracture, the difference between placebo and 150 microg or 300 micro g was even higher at the spine (5.4{\%} and 7.4{\%}, respectively), and at the femoral neck (4.0{\%} and 5.2{\%}, respectively). Correspondingly, uCTX decreased from baseline by 39{\%} and 46 {\%}, and sOC by 22{\%} and 27{\%}, in the 150 micro g group and 300 micro g group (all P<0.001 versus placebo). A strong correlation was found between variations of bone turnover markers after 1 year and BMD after 2 years, emphasizing that bone markers can predict BMD response during hormonal treatment. Acceptability and general tolerance were good. This study demonstrates that pulsed estrogen therapy at the dose of 150 microg and 300-microg per day prevents bone loss in a dose-dependant manner at each site studied, and normalizes bone turnover markers to premenopausal levels.",
keywords = "Administration, Intranasal, Aged, Biological Markers, Bone Density, Bone Remodeling, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Estradiol, Estrogen Replacement Therapy, Female, Femur Neck, Humans, Lumbar Vertebrae, Middle Aged, Osteoporosis, Postmenopausal",
author = "Nielsen, {Therese F} and Pernille Ravn and Bagger, {Yu Z} and Lise Warming and Claus Christiansen",
year = "2004",
month = "2",
day = "1",
doi = "10.1007/s00198-003-1535-8",
language = "English",
volume = "15",
pages = "168--74",
journal = "Osteoporosis International",
issn = "0937-941X",
publisher = "Springer",
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}

Pulsed estrogen therapy in prevention of postmenopausal osteoporosis. A 2-year randomized, double blind, placebo-controlled study. / Nielsen, Therese F; Ravn, Pernille; Bagger, Yu Z; Warming, Lise; Christiansen, Claus.

I: Osteoporosis International, Bind 15, Nr. 2, 01.02.2004, s. 168-74.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Pulsed estrogen therapy in prevention of postmenopausal osteoporosis. A 2-year randomized, double blind, placebo-controlled study.

AU - Nielsen, Therese F

AU - Ravn, Pernille

AU - Bagger, Yu Z

AU - Warming, Lise

AU - Christiansen, Claus

PY - 2004/2/1

Y1 - 2004/2/1

N2 - The aim of this study was to evaluate the efficacy of pulsed estrogen therapy (intranasal 17beta-estradiol) in the prevention of postmenopausal bone loss. A total of 386 women (40-65 years old), less than 5 years past menopause, were randomized to intranasal placebo, 17beta-estradiol 150 micro g, or 300 micro g daily for 2 years. Women with an intact uterus received micronised progesterone 200 mg per day, 14 days of each 28-day cycle. Women randomised to placebo-treatment received placebo progesterone. The primary endpoints were changes in BMD at the spine (L2-L4) and femoral neck. Secondary endpoints were changes in bone turnover markers: serum osteocalcin (sOC) as a marker of bone formation and urinary C-terminal telopeptides (uCTX) as a marker of bone resorption. BMD increased at all measured sites in women receiving active treatment in a dose-related manner, the difference compared to placebo being 5.2% and 6.7% at the spine, and 3.2% and 4.7 % at the hip, respectively, with 150 microg and 300 microg ( P<0.001). On the other hand, a decrease versus baseline of -3.2% and -3.3% at the spine and hip, respectively, was observed in women receiving placebo ( P<0.001). In the patients with at least one risk factor for osteoporotic fracture, the difference between placebo and 150 microg or 300 micro g was even higher at the spine (5.4% and 7.4%, respectively), and at the femoral neck (4.0% and 5.2%, respectively). Correspondingly, uCTX decreased from baseline by 39% and 46 %, and sOC by 22% and 27%, in the 150 micro g group and 300 micro g group (all P<0.001 versus placebo). A strong correlation was found between variations of bone turnover markers after 1 year and BMD after 2 years, emphasizing that bone markers can predict BMD response during hormonal treatment. Acceptability and general tolerance were good. This study demonstrates that pulsed estrogen therapy at the dose of 150 microg and 300-microg per day prevents bone loss in a dose-dependant manner at each site studied, and normalizes bone turnover markers to premenopausal levels.

AB - The aim of this study was to evaluate the efficacy of pulsed estrogen therapy (intranasal 17beta-estradiol) in the prevention of postmenopausal bone loss. A total of 386 women (40-65 years old), less than 5 years past menopause, were randomized to intranasal placebo, 17beta-estradiol 150 micro g, or 300 micro g daily for 2 years. Women with an intact uterus received micronised progesterone 200 mg per day, 14 days of each 28-day cycle. Women randomised to placebo-treatment received placebo progesterone. The primary endpoints were changes in BMD at the spine (L2-L4) and femoral neck. Secondary endpoints were changes in bone turnover markers: serum osteocalcin (sOC) as a marker of bone formation and urinary C-terminal telopeptides (uCTX) as a marker of bone resorption. BMD increased at all measured sites in women receiving active treatment in a dose-related manner, the difference compared to placebo being 5.2% and 6.7% at the spine, and 3.2% and 4.7 % at the hip, respectively, with 150 microg and 300 microg ( P<0.001). On the other hand, a decrease versus baseline of -3.2% and -3.3% at the spine and hip, respectively, was observed in women receiving placebo ( P<0.001). In the patients with at least one risk factor for osteoporotic fracture, the difference between placebo and 150 microg or 300 micro g was even higher at the spine (5.4% and 7.4%, respectively), and at the femoral neck (4.0% and 5.2%, respectively). Correspondingly, uCTX decreased from baseline by 39% and 46 %, and sOC by 22% and 27%, in the 150 micro g group and 300 micro g group (all P<0.001 versus placebo). A strong correlation was found between variations of bone turnover markers after 1 year and BMD after 2 years, emphasizing that bone markers can predict BMD response during hormonal treatment. Acceptability and general tolerance were good. This study demonstrates that pulsed estrogen therapy at the dose of 150 microg and 300-microg per day prevents bone loss in a dose-dependant manner at each site studied, and normalizes bone turnover markers to premenopausal levels.

KW - Administration, Intranasal

KW - Aged

KW - Biological Markers

KW - Bone Density

KW - Bone Remodeling

KW - Dose-Response Relationship, Drug

KW - Double-Blind Method

KW - Drug Administration Schedule

KW - Estradiol

KW - Estrogen Replacement Therapy

KW - Female

KW - Femur Neck

KW - Humans

KW - Lumbar Vertebrae

KW - Middle Aged

KW - Osteoporosis, Postmenopausal

U2 - 10.1007/s00198-003-1535-8

DO - 10.1007/s00198-003-1535-8

M3 - Journal article

VL - 15

SP - 168

EP - 174

JO - Osteoporosis International

JF - Osteoporosis International

SN - 0937-941X

IS - 2

ER -