search
Back to results

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

Primary Purpose

Breast Cancer, Menopause, Osteopenia

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Risedronate
Placebo
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Aromatase inhibitor treatment, osteoporosis, breast cancer, bisphosphonates

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

2

1

Arm Description

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

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

Outcomes

Primary Outcome Measures

Evolution of the lumbar spine Bone Mineral Density after one year of treatment

Secondary Outcome Measures

Evolution of femoral BMD after one year of treatment
Evolution of lumbar spine and femoral BMD after two years of treatment
Evolution of bone resorption and formation markers
Proportion of fractures after two years of treatment
Evolution of estradiol levels

Full Information

First Posted
March 10, 2009
Last Updated
October 30, 2013
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT00859703
Brief Title
Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Menopause, Osteopenia
Keywords
Aromatase inhibitor treatment, osteoporosis, breast cancer, bisphosphonates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
1
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Risedronate
Intervention Description
35mg oral risedronate once per week for 24 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 35 mg once a week for 24 months
Primary Outcome Measure Information:
Title
Evolution of the lumbar spine Bone Mineral Density after one year of treatment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evolution of femoral BMD after one year of treatment
Time Frame
1 year
Title
Evolution of lumbar spine and femoral BMD after two years of treatment
Time Frame
2 years
Title
Evolution of bone resorption and formation markers
Time Frame
2 years
Title
Proportion of fractures after two years of treatment
Time Frame
2 years
Title
Evolution of estradiol levels
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélie Fontana, M.D
Organizational Affiliation
Hôpital Edouard Herriot
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs