Current partner codePEPTIDESDE
NCT00963417·Not applicable·INTERVENTIONAL

Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02

Status

Completed

Phase

Not applicable

Enrollment

119

Locations

13

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

RATIONALE: Gathering information over time from bone density and laboratory tests of women with breast cancer treated with triptorelin and tamoxifen or exemestane may help the study of breast cancer in the future. PURPOSE: This clinical trial is studying changes in bone mineral density in women with breast cancer treated with triptorelin and tamoxifen or exemestane on protocol IBC SG-25-02 (TEXT).

Full detailed description

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.

Interventions

Treatment arms and agents.

OTHER

laboratory biomarker analysis

Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.

PROCEDURE

dual x-ray absorptiometry

Serial bone mineral density measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA).

Timeline

From registration to results.

  1. First posted

    Aug 21, 2009

  2. Study start

    Aug 3, 2009

  3. Primary completion

    Mar 11, 2011

  4. Study completion

    Oct 23, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Jul 14, 2025

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 72 months after rnadomization to TEXT Study

Serial serum levels of IGF-1 and IGFBP-3

Time frame · 72 months after randomization to TEXT Study

Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)

Time frame · 72 months after randomization to TEXT Study

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
120 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

13 registered sites.

Australia · Belgium · Switzerland. Showing up to 24 locations stored in the fast local snapshot.

Royal Brisbane and Women's Hospital

Brisbane, Australia

Peter MacCallum Cancer Center

East Melbourne, Australia

Box Hill Hospital

Melbourne, Australia

Maroondah Hospital

Melbourne, Australia

Royal Perth Hospital

Perth, Australia

Centre Hospitalier Regional de Huy

Huy, Belgium

UZ Leuven

Leuven, Belgium

C.H.U. Sart Tilman

Liège, Belgium

CHR Citadelle

Liège, Belgium

C.H.P.L.T. de Verviers

Verviers, Belgium

Oncology Institute of Southern Switzerland

Bellinzona, Switzerland

Inselspital Bern

Bern, Switzerland

Kantonsspital St.Gallen

Sankt Gallen, Switzerland

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Triptorelin.

Related PeptideStat pages

Put the record in context.

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