Effect of the antiresorptive treatment with alendronate versus no treatment after denosumab and aromatase inhibitors discontinuation in low fracture risk osteopenic postmenopausal women with non metastatic hormonal receptor positive breast cancer (the ADAIDO study, Alendronate after Denosumab and Aromatase Inhibitors Discontinuation in Osteopenic women with breast cancer). -

IRCCS ISTITUTO ORTOPEDICO GALEAZZI S.P.A0 个研究点目标入组 190 人开始时间: 2021年6月8日最近更新: 2023年1月9日

试验速览

暂无简介。

•- Patient who have signed and dated the informed consent form approved by EC, before undergoing any study-specific procedure;
•- Postmenopausal women (absence of spontaneous menstrual cycle for at least 12 months);
•- Treated for breast cancer with AI (letrozole, anastrozole, examestane) for at least two years;
•- Denosumab stopped at least 4 months before ICF signature, after at least 2 year treatment duration to prevent/treat the CTIBL (in primary prevention);
•- Affected with osteopenia, diagnosed as femoral T-scores by DXA performed within the last 36 months from the AI discontinuation, within the range -1.0 to -2.4 (WHO criteria for diagnosis of osteoporosis)[16],
•- with low risk fracture, defined as a 10-years predicted fracture risk < 20% for major osteoporotic fractures and < 3% for femur fractures according the FRAX algorithm (http://www.shef.ac.uk/FRAX/)
•- Stopping AI treatment within the 6 months from the last denosumab administration [14]
•- Current supplementation with calcium and vitamin D (according clinical routine practice).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 130
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•- Age > 75 years;
•- BMI < 20 e > 35 kg/m2;
•- Osteoporosis diagnosed as femoral T-score by DXA ¿ -2.5 (test performed as routine)
•- Clinical or morphometric fractures detected by thoracic and lumbar Rx
•- Recent invasive dental surgery with no complete healing at moment of inclusion
•- Type 1 diabetes mellitus;
•- Poorly controlled type 2 diabetes mellitus (HbA1c >7.5%, 58 mmol/mol);
•- Rheumatoid arthritis;
•- Current steroid or immunosuppressive therapies;
•- Active endocrinopathies (except hypothyroidism with good hormonal balance);
•-Chronic alcoholism
•- Chronic kidney disease stages 4-5 according to CKD-EPI (eGFR < 30 ml/min) (test performed as routine);
•- Hepatic cirrhosis, HCV and HBV-related chronic hepatitis, autoimmune hepatitis (autodeclaration);
•- Previous treatments with amino-bisphosphonates (except previous treatment with clodronate);
•- Known history of reflux esophagitis.
•- Other known contraindications to bisphosphonates

发起方

IRCCS ISTITUTO ORTOPEDICO GALEAZZI S.P.A