Study 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.

Phase 1

• Conditions: post-menopausal osteoporosis in women with non-metastatic hormonal receptor positive (HR+) breast cancer.; MedDRA version: 20.0Level: PTClassification code 10049088Term: OsteopeniaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-005343-23-IT
• Lead Sponsor: IRCCS ISTITUTO ORTOPEDICO GALEAZZI S.P.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 190

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 < 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified