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TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Osteoporosis

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Trial Information

TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density


OBJECTIVES:

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Patient must be eligible and enrolled in the TEXT-2 trial prior to enrolling in
TEXT-Bone

- Serial bone marrow density (BMD) measurements must be taken within the same
institution

- Hormone receptor positive

PATIENT CHARACTERISTICS:

- See Disease Characteristics

- Premenopausal

- No bone fracture in the past 6 months that, in the investigator's judgement, could be
related to bone fragility

- No clinical or biochemical malabsorption syndrome, known vitamin D deficiency, active
hyper- or hypoparathyroidism, or Paget's disease

- No uncontrolled thyroid disease, Cushing disease, or other pituitary diseases

- No other bone disease (including osteomalacia or osteogenesis imperfecta)

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 6 months since prior and no concurrent bisphosphonate therapy (or other bone
therapies such as PTH or strontium)

- At least 6 months since prior glucocorticoid (> 5 mg prednisone or equivalent) for >
1 month

- At least 12 months since prior anticonvulsants

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase

Outcome Time Frame:

72 months after rnadomization to TEXT Study

Safety Issue:

No

Principal Investigator

Olivia Pagani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Authority:

United States: Federal Government

Study ID:

CDR0000637437

NCT ID:

NCT00963417

Start Date:

July 2009

Completion Date:

December 2018

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • osteoporosis
  • estrogen receptor-positive breast cancer
  • progesterone receptor-positive breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms
  • Osteoporosis

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