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Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.


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

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Trial Information

Randomized, Double-blinded, Placebo Controlled Study to Assess Efficacy of Oral 35 mg Per Week Risedronate in Preventing Bone Loss in Postmenopausal Women With Aromatase Inhibitor Therapy for Breast Cancer.


Inclusion Criteria:



- Postmenopausal women (more than one year since last menstrual period or removal of
ovarian function by surgical or radiotherapic means)

- Operated for an invasive breast cancer (histologically proven)

- Surgical treatment completed and cycles of adjuvant chemotherapy (if necessary)
completed

- Treated with aromatase inhibitor

- Osteopenic (-2.5
- With written informed consent signed

- With social security

Exclusion Criteria:

- Women presenting a history of osteoporotic fracture or a T score less than -2.5 at at
least one measure site

- Women presenting clinical signs of metastases

- Having received other hormonal treatment in the last 3 months

- Having received treatment by bisphosphonates, raloxifene, tamoxifen, parathormone,
strontium ranelate, tibolone,calcitonin and corticosteroids at more than 5mg/d for 3
months in the last year

- Presenting a known and untreated hyperthyroid

- Presenting a known hyperadrenocorticism

- Patients treated and followed for Paget's disease of bone

- Presenting a untreated primary hyperparathyroid

- Presenting an indication against risedronate (known hypersensibility to risedronate
monosodium and/or one of its excipients, non-corrected hypocalcemia, pregnancy or
breast feeding, severe renal insufficiency inferior to 30 ml/min)

- Patients presenting malabsorption syndrome for glucose/galactose

- Person participating in another clinical trial concerning a medicine susceptible to
influence bone mass

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evolution of the lumbar spine Bone Mineral Density after one year of treatment

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Aurélie Fontana, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Edouard Herriot

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2006.45346

NCT ID:

NCT00859703

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Menopause
  • Osteopenia
  • Aromatase inhibitor treatment
  • osteoporosis
  • breast cancer
  • bisphosphonates
  • Breast Neoplasms
  • Bone Diseases, Metabolic

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