Breast CancerPhase 3RISAROSNCT00859703
Study to Assess Efficacy of Risedronate in Preventing Bone Loss in Postmenopausal Women Treated for Breast Cancer
A Phase 3 study testing Risedronate in people with Breast Cancer and Menopause, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Menopause, Osteopenia
- What is being tested?
- Risedronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot
Lyon, 69437
About this study
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.
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
- Conditions
- Breast Cancer, Menopause, Osteopenia
- Being tested
- Risedronate, Placebo
- Keywords
- Aromatase inhibitor treatment, osteoporosis, breast cancer, bisphosphonates
- Medical subject headings
- Breast Neoplasms, Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisedronateDrug
35mg oral risedronate once per week for 24 months
PlaceboDrug
Placebo 35 mg once a week for 24 months
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | 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 Receives: Drug: Placebo |
| 1 | Active comparator | 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 Receives: Drug: Risedronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the lumbar spine Bone Mineral Density after one year of treatment
Measured: 1 year
Secondary outcomes (5)
Evolution of femoral BMD after one year of treatment
Measured: 1 year
Evolution of lumbar spine and femoral BMD after two years of treatment
Measured: 2 years
Evolution of bone resorption and formation markers
Measured: 2 years
Proportion of fractures after two years of treatment
Measured: 2 years
Evolution of estradiol levels
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie Fontana, M.D, Principal investigator, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859703
- Sponsor's protocol ID
- 2006.45346
- Acronym
- RISAROS
- Status last verified
- Oct 2013
- First submitted
- 10 Mar 2009
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PubMed 38979716
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00859703
- Acronym / sponsor ID
- RISAROS / 2006.45346
- Conditions
- Breast Cancer, Menopause, Osteopenia
- Keywords
- Aromatase inhibitor treatment, osteoporosis, breast cancer, bisphosphonates
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: PlaceboPatients 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 |
| 1 | Active comparator | Drug: RisedronatePatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risedronate35mg oral risedronate once per week for 24 months | Drug | 1 |
| PlaceboPlacebo 35 mg once a week for 24 months | Drug | 2 |
Primary outcome
Evolution of the lumbar spine Bone Mineral Density after one year of treatment
Time frame: 1 year
5 secondary outcomes
Evolution of femoral BMD after one year of treatment
Time frame: 1 year
Evolution of lumbar spine and femoral BMD after two years of treatment
Time frame: 2 years
Evolution of bone resorption and formation markers
Time frame: 2 years
Proportion of fractures after two years of treatment
Time frame: 2 years
Evolution of estradiol levels
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Derived from this study: PubMed 38979716Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie Fontana, M.D principal investigator
Hôpital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risedronate in people with Breast Cancer and Menopause, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the lumbar spine Bone Mineral Density after one year of treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00859703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.