TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density
- Evaluate changes in bone mineral density (BMD) among premenopausal women randomized in
protocol IBC SG-25202 (TEXT-2) to receive either: A) triptorelin (GnRH analogue) for 5
years plus tamoxifen for 5 years; or B) triptorelin (GnRH analogue) for 5 years plus
the steroidal aromatase inhibitor exemestane for 5 years.
- Evaluate serial serum markers for bone remodeling (C-telopeptide, osteocalcin,
bone-specific alkaline phosphatase) and investigate their correlation with BMD.
- Evaluate the relationship of genetic variants of CYP19A1, ERα, ERß, and IGF 1 with BMD.
- Evaluate serial serum growth factors (IGF-1 and IGFBP-3) and investigate whether their
time course correlates with BMD.
- Explore the role of serum IGF-1 and IGFBP-3 as biomarkers of disease outcome
(disease-free survival). (exploratory)
OUTLINE: Blood samples are collected at baseline and then periodically for 6 years. Serum
markers of bone remodeling and serum growth factor levels are measured.
Bone mineral density in the L1-L4 (postero-anterior) region of the spine and femoral neck of
the hip is measured by DEXA at baseline and then periodically for 6 years.
Any surplus serum is stored for use in unspecified future research.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
72 months after rnadomization to TEXT Study
Olivia Pagani, MD
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
United States: Federal Government