Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer

Condition(s) targeted: Breast Cancer; Menopause; Osteopenia

Intervention: Risedronate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Aurélie Fontana, M.D, Principal Investigator, Affiliation: Hôpital Edouard Herriot

Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures.

This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer

Official title: 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.

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

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

Secondary outcome:

Evolution of femoral BMD after one year of treatment

Evolution of lumbar spine and femoral BMD after two years of treatment

Evolution of bone resorption and formation markers

Proportion of fractures after two years of treatment

Evolution of estradiol levels

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot, Lyon, Rhone-Alps 69437, France; Recruiting
Aurélie Fontana, Phone: 0033 4 72 11 74 61, Ext: 31 74 61, Email: aurelie.fontana@chu-lyon.fr

Starting date: November 2009
Last updated: November 18, 2009