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

October 30, 2013 updated by: Hospices Civils de Lyon

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69437
        • Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evolution of the lumbar spine Bone Mineral Density after one year of treatment
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evolution of femoral BMD after one year of treatment
Time Frame: 1 year
1 year
Evolution of lumbar spine and femoral BMD after two years of treatment
Time Frame: 2 years
2 years
Evolution of bone resorption and formation markers
Time Frame: 2 years
2 years
Proportion of fractures after two years of treatment
Time Frame: 2 years
2 years
Evolution of estradiol levels
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Aurélie Fontana, M.D, Hôpital Edouard Herriot

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

March 10, 2009

First Submitted That Met QC Criteria

March 10, 2009

First Posted (ESTIMATE)

March 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2013

Last Update Submitted That Met QC Criteria

October 30, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006.45346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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