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

Study Overview
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Brief Summary
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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
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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.

Conditions
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Breast Cancer, Menopause, Osteopenia

Intervention / Treatment
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* Drug: Risedronate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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<T score<-1) without osteoporotic fracture 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>Patients receive placebo 35 mg once a week plus a calcium and vitamin D supplementation. Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment | Drug: Placebo<br>* Placebo 35 mg once a week for 24 months<br>|
| Active Comparator: 1<br>Patients receive risedronate 35 mg once a week plus a calcium and vitamin D supplementation. Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment | Drug: Risedronate<br>* 35mg oral risedronate once per week for 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the lumbar spine Bone Mineral Density after one year of treatment |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of femoral BMD after one year of treatment |  | 1 year | 
| Evolution of lumbar spine and femoral BMD after two years of treatment |  | 2 years | 
| Evolution of bone resorption and formation markers |  | 2 years | 
| Proportion of fractures after two years of treatment |  | 2 years | 
| Evolution of estradiol levels |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aromatase inhibitor treatment, osteoporosis, breast cancer, bisphosphonates