post-menopausal osteoporosis in women with non-metastatic hormonal receptor positive (HR+) breast cancer. MedDRA version: 20.0 Level: PT Classification code 10049088 Term: Osteopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: BINOSTO - 70 MG COMPRESSE EFFERVESCENTI
Product Name: Acido Alendronico
Product Code: [Binosto]
Pharmaceutical Form: Effervescent tablet
INN or Proposed INN: ACIDO ALENDRONICO
CAS Number:
Sponsors
IRCCS ISTITUTO ORTOPEDICO GALEAZZI S.P.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: - Age > 75 years; - BMI 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of alendronate versus no treatment on bone mineral density (BMD) in the following 12 months after the denosumab and aromatase inhibitors (AI) discontinuation in low fracture risk (defined as a10-years predicted fracture risk < 20% for major osteoporotic fractures and < 3% for femur fractures according the FRAX algorithm) osteopenic women with post-menopausal non-metastatic hormonal receptor positive (HR+) breast cancer.;Secondary Objective: In low fracture risk osteopenic women with post-menopausal non-metastatic hormonal receptor positive (HR+) breast cancer, to evaluate the effect of alendronate versus no treatment: 1. on the turnover biomarkers in the following 3, 12 and 24 months after the denosumab and aromatase inhibitors (AI) discontinuation 2. on bone mineral density (BMD) at the end of 24 months of follow up after the denosumab and aromatase inhibitors (AI) discontinuation 3. on vertebral and non-vertebral fractures in the following two years after the denosumab and AI discontinuation 4. on morphometric vertebral fractures in the following 12 and 24 months after the denosumab and AI discontinuation in low fracture risk osteopenic women with post-menopausal breast cancer. 5. To monitor the adverse events/clinical in treated and untreated patients.;Primary end point(s): Percent changes in BMD measured at lumbar and femoral sites at 12 months with respect to basal conditions;Timepoint(s) of evaluation of this end point: Basal assessment (time 0) and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. changes in serum bone-specific alkaline phosphatase activity, CTX, P1NP and FGF23 at 3, 12 and 24 months with respect to basal levels; 2. changes in BMD measured at lumbar and femoral sites at 24 months with respect to basal conditions; 3. occurrence of new fragility fractures at any sites anamnestically recorded at 3, 12 and 24 months visits; 4. detection of new morphometric vertebral fractures by thoracic and lumbar Rx at 12 and 24 months of follow up; 5. incidence of the adverse events/clinical and morphometric fractures in treated and untreated patients;Timepoint(s) of evaluation of this end point: 1. Basal assessment (time 0), 3, 12 and 24 months 2. Basal assessment (time 0) and 24 months 3. 3, 12 and 24 months 4. 12 and 24 months 5 . Up to 24 months | — |
Countries
Italy
Contacts
Public ContactDipartimento Medico
OPIS s.r.l.
Outcome results
None listed