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
  Purpose

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


Condition Intervention Phase
Breast Cancer
Menopause
Osteopenia
Drug: Risedronate
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Evolution of the lumbar spine Bone Mineral Density after one year of treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Drug: Placebo
Placebo 35 mg once a week for 24 months
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859703

Locations
France
Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot
Lyon, France, 69437
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Aurélie Fontana, M.D Hôpital Edouard Herriot
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00859703     History of Changes
Other Study ID Numbers: 2006.45346
Study First Received: March 10, 2009
Last Updated: October 30, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
Aromatase inhibitor treatment
osteoporosis
breast cancer
bisphosphonates

Additional relevant MeSH terms:
Breast Neoplasms
Bone Diseases, Metabolic
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Etidronic Acid
Aromatase Inhibitors
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014