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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00963417




Registration number
NCT00963417
Ethics application status
Date submitted
20/08/2009
Date registered
21/08/2009

Titles & IDs
Public title
Study of Bone Mineral Density in Women With Breast Cancer Treated With Triptorelin and Tamoxifen or Exemestane on Protocol IBCSG 25-02
Scientific title
TEXT-Bone: A Substudy of the TEXT Trial to Evaluate Serial Bone Markers for Bone Remodeling, Serial Growth Factors, and Bone Mineral Density
Secondary ID [1] 0 0
IBCSG-25A-02
Secondary ID [2] 0 0
CDR0000637437
Universal Trial Number (UTN)
Trial acronym
TEXT-Bone
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Osteoporosis 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - laboratory biomarker analysis
Treatment: Surgery - dual x-ray absorptiometry

Active comparator: Triptorelin plus tamoxifen - Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus tamoxifen for 5 years.

Experimental: Triptorelin plus exemestane - Determination of bone mineral density in patients randomized in TEXT-1 or TEXT-2 trials to receive triptorelin (GnRH analogue) for 5 years plus exemestane for 5 years.


Other interventions: laboratory biomarker analysis
Serial serum levels of several biomarkers will be analyzed at different time points, up to 72 months after randomization.

Treatment: Surgery: 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).
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serial serum levels of C-telopeptide, osteocalcin, and bone-specific alkaline phosphatase
Timepoint [1] 0 0
72 months after rnadomization to TEXT Study
Primary outcome [2] 0 0
Serial serum levels of IGF-1 and IGFBP-3
Timepoint [2] 0 0
72 months after randomization to TEXT Study
Primary outcome [3] 0 0
Serial BMD measurements of the L1-L4 (postero-anterior, PA) region of the spine and hip by dual-energy X-ray absorptiometry (DEXA)
Timepoint [3] 0 0
72 months after randomization to TEXT Study

Eligibility
Key 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
Minimum age
18 Years
Maximum age
120 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Center - East Melbourne
Recruitment hospital [3] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [4] 0 0
Maroondah Hospital - Melbourne
Recruitment hospital [5] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Huy
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Belgium
State/province [3] 0 0
Liège
Country [4] 0 0
Belgium
State/province [4] 0 0
Verviers
Country [5] 0 0
Switzerland
State/province [5] 0 0
Bellinzona
Country [6] 0 0
Switzerland
State/province [6] 0 0
Bern
Country [7] 0 0
Switzerland
State/province [7] 0 0
St.Gallen

Funding & Sponsors
Primary sponsor type
Other
Name
ETOP IBCSG Partners Foundation
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Breast International Group
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Olivia Pagani, MD
Address 0 0
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00963417