Efficacy of a combined alendronate and calcitriol agent (Maxmarvil&lt;sup&gt;®&lt;/sup&gt;) in Korean postmenopausal women with early breast cancer receiving aromatase inhibitor: a double-blind, randomized, placebo-controlled study

Rhee, Yumie; Song, Keun Jeong; Park, Seho; Park, Hyung Seok; Lim, Sung Kil; Park, Byeong Woo

doi:10.1507/endocrj.ej12-0283

Cited by 23 publications

(22 citation statements)

References 18 publications

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“…After 24-week of treatment, between group differences is lumbar spine BMD was 3.0% ( p <0.005). The increase in C-telopeptide after 24 weeks was significantly less in the treatment group compared with that in the placebo group (35.2±17.5% vs. 109.8±28.6%, p <0.05) [109]. In all of the studies of oral bisphosphonates, patients who did not receive a bisphosphonate experienced substantial BMD loss during AI therapy [111].…”

Section: Selecting a Treatment To Prevent Aiblmentioning

confidence: 92%

See 1 more Smart Citation

Management of Aromatase Inhibitor-Associated Bone Loss (AIBL) in postmenopausal women with hormone sensitive breast cancer: Joint position statement of the IOF, CABS, ECTS, IEG, ESCEO, IMS, and SIOG

Hadji

Aapro

Body

et al. 2017

Journal of Bone Oncology

224

182

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BackgroundSeveral guidelines have been reported for bone-directed treatment in women with early breast cancer (EBC) for averting fractures, particularly during aromatase inhibitor (AI) therapy. Recently, a number of studies on additional fracture related risk factors, new treatment options as well as real world studies demonstrating a much higher fracture rate than suggested by randomized clinical controlled trials (RCTs). Therefore, this updated algorithm was developed to better assess fracture risk and direct treatment as a position statement of several interdisciplinary cancer and bone societies involved in the management of AI-associated bone loss (AIBL).Patients and methodsA systematic literature review identified recent advances in the management of AIBL. Results with individual agents were assessed based on trial design, size, follow-up, and safety.ResultsSeveral fracture related risk factors in patients with EBC were identified. Although, the FRAX algorithm includes fracture risk factors (RF) in addition to BMD, it does not seem to adequately address the effects of AIBL. Several antiresorptive agents can prevent and treat AIBL. However, concerns regarding compliance and long-term safety remain. Overall, the evidence for fracture prevention is strongest for denosumab 60 mg s.c. every 6 months. Additionally, recent studies as well as an individual patient data meta-analysis of all available randomized trial data support additional anticancer benefits from adjuvant bisphosphonate treatment in postmenopausal women with a 34% relative risk reduction in bone metastasis and 17% relative risk decrease in breast cancer mortality that needs to be taken into account when advising on management of AIBL.ConclusionsIn all patients initiating AI treatment, fracture risk should be assessed and recommendation with regard to exercise and calcium/vitamin D supplementation given. Bone-directed therapy should be given to all patients with a T-score<−2.0 or with a T-score of <–1.5 SD with one additional RF, or with ≥2 risk factors (without BMD) for the duration of AI treatment. Patients with T-score>−1.5 SD and no risk factors should be managed based on BMD loss during the first year and the local guidelines for postmenopausal osteoporosis. Compliance should be regularly assessed as well as BMD on treatment after 12 - 24 months. Furthermore, because of the decreased incidence of bone recurrence and breast cancer specific mortality, adjuvant bisphosphonates are recommended for all postmenopausal women at significant risk of disease recurrence.

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Section: Selecting a Treatment To Prevent Aiblmentioning

confidence: 92%

“…In the BATMAN study, all 303 postmenopausal women with early breast cancer (EBC) received anastrozole (1 mg daily), calcium and vitamin D weekly [109]. All osteoporotic patients received weekly alendronate (70 mg) while osteopenic patients received alendronate or placebo in accordance to a given algorithm.…”

Section: Selecting a Treatment To Prevent Aiblmentioning

confidence: 99%

Management of Aromatase Inhibitor-Associated Bone Loss (AIBL) in postmenopausal women with hormone sensitive breast cancer: Joint position statement of the IOF, CABS, ECTS, IEG, ESCEO, IMS, and SIOG

Hadji

Aapro

Body

et al. 2017

Journal of Bone Oncology

224

182

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“…Bone remodeling is a tightly regulated process leading to balanced resorption and formation of skeletal tissue with the coordinated action of osteocytes [ 1 , 2 ]. Sclerostin is a glycoprotein secreted by osteocytes and a potent Wnt inhibitor.…”

Section: Introductionmentioning

confidence: 99%

“…This is the preferred adjuvant therapy for postmenopausal women with estrogen receptor/progesterone receptor-positive breast cancer, because it reduces breast cancer recurrence up to 50% compared to tamoxifen [ 11 , 12 , 13 ]. AIs affect bone metabolism by increasing bone turnover rates and accelerating bone loss, leading to increased fracture risk [ 2 , 14 , 15 , 16 ]. Bisphosphonates are the preferred treatment for AI-induced bone loss [ 2 ], and calcitriol, an active metabolite of vitamin D, in combination with an AI is effective for inhibiting tumors [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Increased Sclerostin Levels after Further Ablation of Remnant Estrogen by Aromatase Inhibitors

et al. 2015

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BackgroundSclerostin is a secreted Wnt inhibitor produced almost exclusively by osteocytes, which inhibits bone formation. Aromatase inhibitors (AIs), which reduce the conversion of steroids to estrogen, are used to treat endocrine-responsive breast cancer. As AIs lower estrogen levels, they increase bone turnover and lower bone mass. We analyzed changes in serum sclerostin levels in Korean women with breast cancer who were treated with an AI.MethodsWe included postmenopausal women with endocrine-responsive breast cancer (n=90; mean age, 57.7 years) treated with an AI, and compared them to healthy premenopausal women (n=36; mean age, 28.0 years). The subjects were randomly assigned to take either 5 mg alendronate with 0.5 µg calcitriol (n=46), or placebo (n=44) for 6 months.ResultsPostmenopausal women with breast cancer had significantly higher sclerostin levels compared to those in premenopausal women (27.8±13.6 pmol/L vs. 23.1±4.8 pmol/L, P<0.05). Baseline sclerostin levels positively correlated with either lumbar spine or total hip bone mineral density only in postmenopausal women (r=0.218 and r=0.233; P<0.05, respectively). Serum sclerostin levels increased by 39.9%±10.2% 6 months after AI use in postmenopausal women; however, no difference was observed between the alendronate and placebo groups (39.9%±10.2% vs. 55.9%±9.13%, P>0.05).ConclusionSerum sclerostin levels increased with absolute deficiency of residual estrogens in postmenopausal women with endocrine-responsive breast cancer who underwent AI therapy with concurrent bone loss.

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“…Vitamin D deficiency has also been linked with increased toxicity from bisphosphonate therapy, which can provoke hypocalcaemia [ 434 ]. Currently, researchers investigate the need to supplement vitamin D and calcium simultaneously with bisphosphonate therapy [ 435 ]. In a double-blind, randomized, placebo-controlled study, Rhee et al proved the efficacy of combined alendronate (5 mg) and calcitriol (0.5 µ g) to prevent bone loss due to aromatase inhibitor in Korean postmenopausal women with early breast cancer.…”

Section: Nutritional Supplementsmentioning

confidence: 99%

Phytotherapy and Nutritional Supplements on Breast Cancer

Lopes

Dourado²,

Oliveira

2017

BioMed Research International

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Breast cancer is the most frequent type of nonskin malignancy among women worldwide. In general, conventional cancer treatment options (i.e., surgery, radiotherapy, chemotherapy, biological therapy, and hormone therapy) are not completely effective. Recurrence and other pathologic situations are still an issue in breast cancer patients due to side effects, toxicity of drugs in normal cells, and aggressive behaviour of the tumours. From this point of view, breast cancer therapy and adjuvant methods represent a promising and challenging field for researchers. In the last few years, the use of some types of complementary medicines by women with a history of breast cancer has significantly increased such as phytotherapeutic products and nutritional supplements. Despite this, the use of such approaches in oncologic processes may be problematic and patient's health risks can arise such as interference with the efficacy of standard cancer treatment. The present review gives an overview of the most usual phytotherapeutic products and nutritional supplements with application in breast cancer patients as adjuvant approach. Regardless of the contradictory results of scientific evidence, we demonstrated the need to perform additional investigation, mainly well-designed clinical trials in order to establish correlations and allow for further validated outcomes concerning the efficacy, safety, and clinical evidence-based recommendation of these products.

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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

Cited by 23 publications

References 18 publications

Management of Aromatase Inhibitor-Associated Bone Loss (AIBL) in postmenopausal women with hormone sensitive breast cancer: Joint position statement of the IOF, CABS, ECTS, IEG, ESCEO, IMS, and SIOG

Management of Aromatase Inhibitor-Associated Bone Loss (AIBL) in postmenopausal women with hormone sensitive breast cancer: Joint position statement of the IOF, CABS, ECTS, IEG, ESCEO, IMS, and SIOG

Increased Sclerostin Levels after Further Ablation of Remnant Estrogen by Aromatase Inhibitors

Phytotherapy and Nutritional Supplements on Breast Cancer

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