Efficacy of a combined alendronate and calcitriol agent (Maxmarvil¢ç) in Korean postmenopausal women with early breast cancer receiving aromatase inhibitor: a double-blind, randomized, placebo-controlled study.

Rhee, Yumie; Song, Kijun; Park, Seho; Park, Hyung Seok; Lim, Sung-Kil; Park, Byeong Woo
Endocrine journal
2013NA ; 60 ( 2 ) :167-72.
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Rhee, Yumie -
Song, Kijun -
Park, Seho -
Park, Hyung Seok -
Lim, Sung-Kil -
Park, Byeong Woo -
ABSTRACT
The use of aromatase inhibitor (AI) in postmenopausal women with hormone receptor (HR)-positive early breast cancer (EBC) produces a deleterious effect on bone mass and an increase in fractures. Several studies using intravenous bisphosphonates have shown effective management of AI-induced bone loss. To determine whether a lower dosage in oral form combined with calcitriol can effectively manage AI-induced bone loss, we performed a randomized, double-blind, prospective, placebo-controlled 24-week trial with a combination of alendronate and 0.5-μg of calcitriol daily to HR-positive EBC patients. A total of 98 Korean postmenopausal women with HR-positive EBC who received daily AI, calcium and vitamin D were randomly assigned to 5-mg of alendronate and 0.5-μg of calcitriol (Maxmarvil®) or placebo groups. The bone mineral density (BMD) and turnover markers were measured. At week 24, the difference in lumbar BMD between the groups was 3.0% (p < 0.005). The increase in C-telopeptide after 24 weeks was significantly less in the Maxmarvil group compared to that in the placebo group (35.2 ± 17.5% vs. 109.8 ± 28.6%, p < 0.05). Our study demonstrates that a combination of 5-mg alendronate and 0.5-μg calcitriol is effective to prevent bone loss due to AI in Korean postmenopausal women with EBC.
Aromatse inhibitor, Alendronate, Calcitriol, Combinative agent, Osteoporosis
MESH
Alendronate/administration & dosage/*therapeutic use, Antineoplastic Agents/*adverse effects/therapeutic use, Aromatase Inhibitors/*adverse effects/therapeutic use, Biomarkers/blood, Bone Density/drug effects, Bone Density Conservation Agents/*therapeutic use, Bone Resorption/chemically induced/*prevention & control, Bone and Bones/drug effects/metabolism, Breast Neoplasms/blood/complications/*drug therapy/metabolism, Calcitriol/administration & dosage/*therapeutic use, Calcium, Dietary/therapeutic use, Cholecalciferol/therapeutic use, Collagen Type I/blood/metabolism, Combined Modality Therapy, Dietary Supplements, Double-Blind Method, Drug Combinations, Female, Humans, Middle Aged, Osteoporosis, Postmenopausal/complications/diet therapy/*drug therapy, Patient Dropouts, Peptides/blood/metabolism, Postmenopause, Republic of Korea
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Combination of 5-mg alendronate and 0.5-¥ìg calcitriol is effective to prevent bone loss due to aromatase inhibitor (AI) in Korean postmenopausal women with hormone receptor (HR)-positive early breast cancer (EBC).
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DOI
https://doi.org/10.1507/endocrj.EJ12-0283
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ICD 03
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