Efficacy of a combined alendronate and calcitriol agent (Maxmarvil®) in Korean postmenopausal women with early breast cancer receiving aromatase inhibitor: a double-blind, randomized, placebo-controlled study.
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.
Department of Internal Medicine, Endocrine Research Institute, and Brain Korea 21 Project for Medical Science, Yonsei University College of Medicine, 120-752, Seoul, Korea.
Yumie
Y
Rhee
Kijun
K
Song
Seho
S
Park
Hyung Seok
HS
Park
Sung-Kil
SK
Lim
Byeong Woo
BW
Park
D019386:Alendronate / Q000008:administration & dosage / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D047072:Aromatase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001862:Bone Resorption / Q000139:chemically induced / Q000517:prevention & control*; D001842:Bone and Bones / Q000187:drug effects / Q000378:metabolism; D001943:Breast Neoplasms / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000378:metabolism; D002117:Calcitriol / Q000008:administration & dosage / Q000627:therapeutic use*; D002136:Calcium, Dietary / Q000627:therapeutic use; D002762:Cholecalciferol / Q000627:therapeutic use; D024042:Collagen Type I / Q000097:blood / Q000378:metabolism; D003131:Combined Modality Therapy; D019587:Dietary Supplements; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000178:diet therapy / Q000188:drug therapy*; D010352:Patient Dropouts; D010455:Peptides / Q000097:blood / Q000378:metabolism; D017698:Postmenopause; D056910:Republic of Korea
D000970:Antineoplastic Agents; D047072:Aromatase Inhibitors; D015415:Biomarkers; D050071:Bone Density Conservation Agents; D002136:Calcium, Dietary; D024042:Collagen Type I; D004338:Drug Combinations; C517862:Maxmarvil; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D002762:Cholecalciferol; D002117:Calcitriol; D019386:Alendronate