Clinical trial · Interventional
Fingernails in Evaluating Bone Health in Postmenopausal Women With Breast Cancer Undergoing Hormone Therapy on Clinical Trial IBCSG-1-98
Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient accrual
Summary
Brief summary (as posted)
RATIONALE: Studying samples of fingernails in the laboratory from patients with breast cancer may help in evaluating bone health in postmenopausal women undergoing hormone therapy for breast cancer. PURPOSE: This laboratory study is examining fingernails as a way of evaluating bone health in postmenopausal women with breast cancer undergoing hormone therapy on clinical trial IBCSG-1-98.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| spectroscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- tamoxifen and no bone fracture
- description
- Patients randomized to Arm A of Study BIG 1-98 (tamoxifen for 5 years) who have not had a bone fracture.
- interventionNames
- Procedure: spectroscopy
- type
- EXPERIMENTAL
- label
- Letrozole and no bone fracture
- description
- Patients randomized to Arm B of Study BIG 1-98 (letrozole for 5 years) who have not had a bone fracture.
- interventionNames
- Procedure: spectroscopy
- type
- EXPERIMENTAL
- label
- Tamoxifen and bone fracture
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Enrolled on protocol IBCSG-1-98 * Currently receiving (i.e., have not yet completed) 5 years of treatment with tamoxifen or letrozole and expected to receive ≥ 6 months of additional treatment on protocol IBCSG-1-98 * No recurrent breast cancer or second primary cancer * No known bone disease (including osteomalacia or osteogenesis imperfecta) * Hormone receptor status * Estrogen and/or progesterone receptor positive tumor PATIENT CHARACTERISTICS: * Female * Postmenopausal * No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary diseases * No malabsorption syndrome or clinically relevant vitamin D deficiency PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 1 year since prior and no concurrent anticonvulsants * More than 6 months since prior and no concurrent corticosteroids at doses \> the equivalent of 5 mg/day of prednisone for \> 2 weeks total * No prior or concurrent sodium fluoride at daily doses ≥ 5 mg/day for \> 1 month * More than 12 months since prior and no concurrent anabolic steroids * More than 6 months since any prior drug for the prevention of osteoporosis (excluding calcium or cholecalciferol \[vitamin D\]) * Concurrent warfarin allowed provided duration of treatment is no more than 4 weeks
References
Publications (0)
Data not yet available