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A comparison of raloxifene and calcium plus vitamin D on vaginal atrophy after discontinuation of long-standing postmenopausal hormone therapy in osteoporotic women. A randomized, masked-evaluator, one-year, prospective study.
Maturitas. 2005 Sep 16; 52(1):70-7.M

Abstract

OBJECTIVES

We assessed the effects of the discontinuation of long-standing transdermal estrogen replacement therapy (>4 years) and substitution of this treatment by calcium or raloxifene on the vaginal epithelium and climateric symptoms in a study population of osteoporotic women.

METHODS

A total of 136 women (mean age 55.5 years) were randomized to calcium (500 mg elemental calcium, 400 IU Vitamin D3) (n=40), raloxifene (60 mg/day) (n=48), or estrogen patches (3.9 mg estradiol) and progesterone (100 mg/day) (n=48). Treatment was given for 1 year. The vaginal maturation value (VMV), serum estradiol levels, and climateric symptoms using a 12-item modification of the SF-36 quality of life questionnaire were evaluated at baseline and at 6 and 12 months.

RESULTS

At 6 months, mean VMV decreased significantly (P<0.001) in the calcium (-51.8%) and raloxifene (-18.6%) groups compared with baseline and the estrogen/progesterone group. At 12 months, significant decreases of mean VMV in the calcium (-38.7%) and raloxifene groups (-32%) (P<0.001) were also observed. Serum estradiol levels and changes of VMV correlated significantly at 6 months (rho=0.361, P<0.01) and at 12 months (rho=0.269, P<0.035). A significantly higher number of patients complained of hot flushes and palpitations in the calcium and raloxifene groups than in the estrogen/progesterone group. Raloxifene-treated women reported a significantly higher number of adverse events at 6 months compared to the other treatment groups.

CONCLUSIONS

Withdrawal and change of long-standing transdermal hormone replacement therapy by treatment with calcium or raloxifene resulted in worsening of vaginal atrophy assessed by the VMV, although it was not clinically perceived by the patients. However, increases in dyspareunia and urinary leaks were reported. Menopausal complaints related to vasomotor symptoms worsened in the calcium- and raloxifene-treated groups and persisted throughout the study period.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Hospital Universitari del Mar, Universitat Autonoma de Barcelona, Passeig Marítim 25-29, E-08003, Barcelona, Spain. macheca@imas.imim.esNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16143228

Citation

Checa, M A., et al. "A Comparison of Raloxifene and Calcium Plus Vitamin D On Vaginal Atrophy After Discontinuation of Long-standing Postmenopausal Hormone Therapy in Osteoporotic Women. a Randomized, Masked-evaluator, One-year, Prospective Study." Maturitas, vol. 52, no. 1, 2005, pp. 70-7.
Checa MA, Garrido A, Prat M, et al. A comparison of raloxifene and calcium plus vitamin D on vaginal atrophy after discontinuation of long-standing postmenopausal hormone therapy in osteoporotic women. A randomized, masked-evaluator, one-year, prospective study. Maturitas. 2005;52(1):70-7.
Checa, M. A., Garrido, A., Prat, M., Conangla, M., Rueda, C., & Carreras, R. (2005). A comparison of raloxifene and calcium plus vitamin D on vaginal atrophy after discontinuation of long-standing postmenopausal hormone therapy in osteoporotic women. A randomized, masked-evaluator, one-year, prospective study. Maturitas, 52(1), 70-7.
Checa MA, et al. A Comparison of Raloxifene and Calcium Plus Vitamin D On Vaginal Atrophy After Discontinuation of Long-standing Postmenopausal Hormone Therapy in Osteoporotic Women. a Randomized, Masked-evaluator, One-year, Prospective Study. Maturitas. 2005 Sep 16;52(1):70-7. PubMed PMID: 16143228.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A comparison of raloxifene and calcium plus vitamin D on vaginal atrophy after discontinuation of long-standing postmenopausal hormone therapy in osteoporotic women. A randomized, masked-evaluator, one-year, prospective study. AU - Checa,M A, AU - Garrido,A, AU - Prat,M, AU - Conangla,M, AU - Rueda,C, AU - Carreras,R, PY - 2004/06/07/received PY - 2004/12/17/revised PY - 2004/12/21/accepted PY - 2005/9/7/pubmed PY - 2005/12/13/medline PY - 2005/9/7/entrez SP - 70 EP - 7 JF - Maturitas JO - Maturitas VL - 52 IS - 1 N2 - OBJECTIVES: We assessed the effects of the discontinuation of long-standing transdermal estrogen replacement therapy (>4 years) and substitution of this treatment by calcium or raloxifene on the vaginal epithelium and climateric symptoms in a study population of osteoporotic women. METHODS: A total of 136 women (mean age 55.5 years) were randomized to calcium (500 mg elemental calcium, 400 IU Vitamin D3) (n=40), raloxifene (60 mg/day) (n=48), or estrogen patches (3.9 mg estradiol) and progesterone (100 mg/day) (n=48). Treatment was given for 1 year. The vaginal maturation value (VMV), serum estradiol levels, and climateric symptoms using a 12-item modification of the SF-36 quality of life questionnaire were evaluated at baseline and at 6 and 12 months. RESULTS: At 6 months, mean VMV decreased significantly (P<0.001) in the calcium (-51.8%) and raloxifene (-18.6%) groups compared with baseline and the estrogen/progesterone group. At 12 months, significant decreases of mean VMV in the calcium (-38.7%) and raloxifene groups (-32%) (P<0.001) were also observed. Serum estradiol levels and changes of VMV correlated significantly at 6 months (rho=0.361, P<0.01) and at 12 months (rho=0.269, P<0.035). A significantly higher number of patients complained of hot flushes and palpitations in the calcium and raloxifene groups than in the estrogen/progesterone group. Raloxifene-treated women reported a significantly higher number of adverse events at 6 months compared to the other treatment groups. CONCLUSIONS: Withdrawal and change of long-standing transdermal hormone replacement therapy by treatment with calcium or raloxifene resulted in worsening of vaginal atrophy assessed by the VMV, although it was not clinically perceived by the patients. However, increases in dyspareunia and urinary leaks were reported. Menopausal complaints related to vasomotor symptoms worsened in the calcium- and raloxifene-treated groups and persisted throughout the study period. SN - 0378-5122 UR - https://www.unboundmedicine.com/medline/citation/16143228/A_comparison_of_raloxifene_and_calcium_plus_vitamin_D_on_vaginal_atrophy_after_discontinuation_of_long_standing_postmenopausal_hormone_therapy_in_osteoporotic_women__A_randomized_masked_evaluator_one_year_prospective_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0378-5122(05)00003-4 DB - PRIME DP - Unbound Medicine ER -