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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00859703
First received: March 10, 2009
Last updated: October 30, 2013
Last verified: October 2013

March 10, 2009
October 30, 2013
November 2009
October 2013   (final data collection date for primary outcome measure)
Evolution of the lumbar spine Bone Mineral Density after one year of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00859703 on ClinicalTrials.gov Archive Site
  • Evolution of femoral BMD after one year of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Evolution of lumbar spine and femoral BMD after two years of treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Evolution of bone resorption and formation markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Proportion of fractures after two years of treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Evolution of estradiol levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer
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.

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Breast Cancer
  • Menopause
  • Osteopenia
  • Drug: Risedronate
    35mg oral risedronate once per week for 24 months
  • Drug: Placebo
    Placebo 35 mg once a week for 24 months
  • Placebo Comparator: 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

    Intervention: Drug: Placebo
  • Active Comparator: 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

    Intervention: Drug: Risedronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00859703
2006.45346
No
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Principal Investigator: Aurélie Fontana, M.D Hôpital Edouard Herriot
Hospices Civils de Lyon
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP