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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00859703

Acronym

RISAROS

Enrollment

Registered

2009-03-11

Start date

2009-11-30

Completion date

2013-10-31

Last updated

2013-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Menopause, Osteopenia

Keywords

Aromatase inhibitor treatment, osteoporosis, breast cancer, bisphosphonates

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

Interventions

DRUGRisedronate

35mg oral risedronate once per week for 24 months

DRUGPlacebo

Placebo 35 mg once a week for 24 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Evolution of the lumbar spine Bone Mineral Density after one year of treatment	1 year

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026