Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer
NCT ID: NCT00859703
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2009-11-30
2013-10-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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2
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
Placebo
Placebo 35 mg once a week for 24 months
1
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
Risedronate
35mg oral risedronate once per week for 24 months
Interventions
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Risedronate
35mg oral risedronate once per week for 24 months
Placebo
Placebo 35 mg once a week for 24 months
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Aurélie Fontana, M.D
Role: PRINCIPAL_INVESTIGATOR
Hôpital Edouard Herriot
Locations
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Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot
Lyon, , France
Countries
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References
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Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
Other Identifiers
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2006.45346
Identifier Type: -
Identifier Source: org_study_id