Clinical trial NCT00859703: Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Menopause
Osteopenia
Keywords: Aromatase inhibitor treatment
osteoporosis
breast cancer
bisphosphonates
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2009-03-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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\<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

Primary outcomes:
measure: Evolution of the lumbar spine Bone Mineral Density after one year of treatment
timeFrame: 1 year
Secondary outcomes:
measure: Evolution of femoral BMD after one year of treatment
timeFrame: 1 year
measure: Evolution of lumbar spine and femoral BMD after two years of treatment
timeFrame: 2 years
measure: Evolution of bone resorption and formation markers
timeFrame: 2 years
measure: Proportion of fractures after two years of treatment
timeFrame: 2 years
measure: Evolution of estradiol levels
timeFrame: 2 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot
Study officials:
affiliation: Hôpital Edouard Herriot
name: Aurélie Fontana, M.D
role: PRINCIPAL_INVESTIGATOR
References: