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Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility

Phase 3
30 Years
Not Enrolling
Breast Cancer, Osteoporosis

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Trial Information

Investigating the Chemical Properties of Fingernails to Determine the Efficacy of Nail Structure for Evaluating Bone Fragility



- Compare the effects of tamoxifen vs letrozole on the chemical properties of fingernails
by Raman spectroscopy in postmenopausal women with breast cancer undergoing adjuvant
hormonal therapy on protocol IBCSG-1-98.

- Determine the efficacy of nail structure for evaluating bone fragility.


- Compare fingernail assessments in patients who have had a bone fracture vs those who
have not.

- Determine the natural variation in chemical (Raman spectroscopy) properties of 2
fingernails sourced at 1 appointment from the same donor.

- Evaluate the effect of further drug treatment (after 6 months) on the chemical
properties of fingernails.

OUTLINE: This is a single-blind, multicenter, pilot study. Patients are stratified according
to treatment on protocol IBCSG-1-98 (tamoxifen vs letrozole) and bone fracture (yes vs no).

Fingernail clippings are collected at baseline and 6 months later. Fingernail clippings are
examined by Raman spectroscopy.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Inclusion Criteria


- 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


- Female

- Postmenopausal

- No uncontrolled thyroid or parathyroid disease, Cushing's disease, or other pituitary

- No malabsorption syndrome or clinically relevant vitamin D deficiency


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Determination of bone health using fingernail assessments at baseline and 6 months

Outcome Time Frame:

At baseline and 6 months after inclusion in the trial

Safety Issue:


Principal Investigator

Mark Towler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Materials & Surface Science Institute at the University of Limerick


United States: Federal Government

Study ID:




Start Date:

April 2005

Completion Date:

July 2007

Related Keywords:

  • Breast Cancer
  • Osteoporosis
  • osteoporosis
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms
  • Osteoporosis