Efficacy of a combined alendronate and calcitriol agent (Maxmarvil<sup>®</sup>) in Korean postmenopausal women with early breast cancer receiving aromatase inhibitor: a double-blind, randomized, placebo-controlled study
Copyright policy )Efficacy of a combined alendronate and calcitriol agent (Maxmarvil<sup>®</sup>) 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.
- Yonsei University Medical Library Korea (Republic of)
- Yonsei University Korea (Republic of)
- Yonsei University Health System Korea (Republic of)
Peptides/blood, Calcitriol/administration & dosage, Peptides/metabolism, Bone Density, Breast Neoplasms/blood, Cholecalciferol, Alendronate, Bone Density Conservation Agents, Aromatase Inhibitors, Bone Density Conservation Agents/therapeutic use*, Dietary/therapeutic use, Middle Aged, Combined Modality Therapy, Calcitriol/therapeutic use*, Postmenopause, Drug Combinations, Breast Neoplasms/drug therapy*, Aromatse inhibitor, Combinative agent, Female, Cholecalciferol/therapeutic use, Breast Neoplasms/complications, Patient Dropouts, Bone Resorption/prevention & control*, Collagen Type I/blood, 610, Antineoplastic Agents, Breast Neoplasms, Collagen Type I/metabolism, Bone and Bones/metabolism, Bone and Bones, Collagen Type I, Calcitriol, Double-Blind Method, Republic of Korea, 616, Humans, Bone Resorption/chemically induced, Bone Resorption, Antineoplastic Agents/therapeutic use, Bone and Bones/drug effects, Postmenopausal/complications, Bone Density/drug effects, Alendronate/therapeutic use*, Postmenopausal/diet therapy, Calcium, Dietary, Aromatase Inhibitors/adverse effects*, Postmenopausal/drug therapy*, Alendronate/administration & dosage, Breast Neoplasms/metabolism, Antineoplastic Agents/adverse effects*, Dietary Supplements, Osteoporosis, Calcium, Biomarkers/blood, Biomarkers, Aromatase Inhibitors/therapeutic use
Peptides/blood, Calcitriol/administration & dosage, Peptides/metabolism, Bone Density, Breast Neoplasms/blood, Cholecalciferol, Alendronate, Bone Density Conservation Agents, Aromatase Inhibitors, Bone Density Conservation Agents/therapeutic use*, Dietary/therapeutic use, Middle Aged, Combined Modality Therapy, Calcitriol/therapeutic use*, Postmenopause, Drug Combinations, Breast Neoplasms/drug therapy*, Aromatse inhibitor, Combinative agent, Female, Cholecalciferol/therapeutic use, Breast Neoplasms/complications, Patient Dropouts, Bone Resorption/prevention & control*, Collagen Type I/blood, 610, Antineoplastic Agents, Breast Neoplasms, Collagen Type I/metabolism, Bone and Bones/metabolism, Bone and Bones, Collagen Type I, Calcitriol, Double-Blind Method, Republic of Korea, 616, Humans, Bone Resorption/chemically induced, Bone Resorption, Antineoplastic Agents/therapeutic use, Bone and Bones/drug effects, Postmenopausal/complications, Bone Density/drug effects, Alendronate/therapeutic use*, Postmenopausal/diet therapy, Calcium, Dietary, Aromatase Inhibitors/adverse effects*, Postmenopausal/drug therapy*, Alendronate/administration & dosage, Breast Neoplasms/metabolism, Antineoplastic Agents/adverse effects*, Dietary Supplements, Osteoporosis, Calcium, Biomarkers/blood, Biomarkers, Aromatase Inhibitors/therapeutic use
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