Abstract
This prospective randomized, single-blind, placebo-controlled clinical trial was performed to evaluate the efficacy of raloxifene in preventing the bone loss associated with GnRH agonist (GnRH-a) administration. One hundred premenopausal women with uterine leiomyomas were treated with leuprolide acetate depot at a dosage of 3.75 mg/d for 28 d and then randomized into two groups to receive raloxifene hydrochloride at 60 mg/d (group A) or placebo (1 tablet/d; group B). Bone mineral density (BMD) and serum bone metabolism markers were evaluated at admission and after six treatment cycles. Posttreatment BMD differed significantly from baseline BMD in group B but not in group A. BMD was significantly higher in group A than in group B. In group A, serum osteocalcin and bone alkaline phosphatase levels and urinary deoxypyridinoline and pyrilinks-D excretion were unchanged vs. baseline. Differently, posttreatment concentrations of these bone turnover markers were significantly lower in group B compared with baseline and group A values. In conclusion, raloxifene prevents GnRH-a related bone loss in premenopausal women with uterine leiomyomas.
| Original language | English |
|---|---|
| Pages (from-to) | 4476-4481 |
| Number of pages | 6 |
| Journal | Journal of Clinical Endocrinology and Metabolism |
| Volume | 87 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - Oct 1 2002 |
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ASJC Scopus subject areas
- Biochemistry
- Endocrinology, Diabetes and Metabolism
Cite this
Raloxifene administration in women treated with gonadotropin-releasing hormone agonist for uterine leiomyomas : Effects on bone metabolism. / Palomba, Stefano; Orio, Francesco; Morelli, Michele; Russo, Tiziana; Pellicano, Massimilano; Nappi, Carmine; Mastrantonio, Pasquale; Lombardi, Gaetano; Colao, Annamaria; Zullo, Fulvio.
In: Journal of Clinical Endocrinology and Metabolism, Vol. 87, No. 10, 01.10.2002, p. 4476-4481.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Raloxifene administration in women treated with gonadotropin-releasing hormone agonist for uterine leiomyomas
T2 - Effects on bone metabolism
AU - Palomba, Stefano
AU - Orio, Francesco
AU - Morelli, Michele
AU - Russo, Tiziana
AU - Pellicano, Massimilano
AU - Nappi, Carmine
AU - Mastrantonio, Pasquale
AU - Lombardi, Gaetano
AU - Colao, Annamaria
AU - Zullo, Fulvio
PY - 2002/10/1
Y1 - 2002/10/1
N2 - This prospective randomized, single-blind, placebo-controlled clinical trial was performed to evaluate the efficacy of raloxifene in preventing the bone loss associated with GnRH agonist (GnRH-a) administration. One hundred premenopausal women with uterine leiomyomas were treated with leuprolide acetate depot at a dosage of 3.75 mg/d for 28 d and then randomized into two groups to receive raloxifene hydrochloride at 60 mg/d (group A) or placebo (1 tablet/d; group B). Bone mineral density (BMD) and serum bone metabolism markers were evaluated at admission and after six treatment cycles. Posttreatment BMD differed significantly from baseline BMD in group B but not in group A. BMD was significantly higher in group A than in group B. In group A, serum osteocalcin and bone alkaline phosphatase levels and urinary deoxypyridinoline and pyrilinks-D excretion were unchanged vs. baseline. Differently, posttreatment concentrations of these bone turnover markers were significantly lower in group B compared with baseline and group A values. In conclusion, raloxifene prevents GnRH-a related bone loss in premenopausal women with uterine leiomyomas.
AB - This prospective randomized, single-blind, placebo-controlled clinical trial was performed to evaluate the efficacy of raloxifene in preventing the bone loss associated with GnRH agonist (GnRH-a) administration. One hundred premenopausal women with uterine leiomyomas were treated with leuprolide acetate depot at a dosage of 3.75 mg/d for 28 d and then randomized into two groups to receive raloxifene hydrochloride at 60 mg/d (group A) or placebo (1 tablet/d; group B). Bone mineral density (BMD) and serum bone metabolism markers were evaluated at admission and after six treatment cycles. Posttreatment BMD differed significantly from baseline BMD in group B but not in group A. BMD was significantly higher in group A than in group B. In group A, serum osteocalcin and bone alkaline phosphatase levels and urinary deoxypyridinoline and pyrilinks-D excretion were unchanged vs. baseline. Differently, posttreatment concentrations of these bone turnover markers were significantly lower in group B compared with baseline and group A values. In conclusion, raloxifene prevents GnRH-a related bone loss in premenopausal women with uterine leiomyomas.
UR - http://www.scopus.com/inward/record.url?scp=18644371458&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=18644371458&partnerID=8YFLogxK
U2 - 10.1210/jc.2002-020780
DO - 10.1210/jc.2002-020780
M3 - Article
C2 - 12364422
AN - SCOPUS:18644371458
VL - 87
SP - 4476
EP - 4481
JO - Journal of Clinical Endocrinology and Metabolism
JF - Journal of Clinical Endocrinology and Metabolism
SN - 0021-972X
IS - 10
ER -