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

Breast Cancer Clinical Trial

— RISAROS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859703
• Other study ID #: 2006.45346
• Status: Completed
• Phase: Phase 3
• First received: March 10, 2009
• Last updated: October 30, 2013
• Start date: November 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Menopause
• Osteopenia

Intervention

Drug:
• Risedronate
35mg oral risedronate once per week for 24 months
• Placebo
Placebo 35 mg once a week for 24 months

Locations

Country	Name	City	State
France	Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the lumbar spine Bone Mineral Density after one year of treatment		1 year	No
Secondary	Evolution of femoral BMD after one year of treatment		1 year	No
Secondary	Evolution of lumbar spine and femoral BMD after two years of treatment		2 years	No
Secondary	Evolution of bone resorption and formation markers		2 years	No
Secondary	Proportion of fractures after two years of treatment		2 years	Yes
Secondary	Evolution of estradiol levels		2 years	No