Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Menopause | — | UNRESOLVED | — |
| Osteopenia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Risedronate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- 2
- 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
- interventionNames
- Drug: Placebo
- type
- ACTIVE_COMPARATOR
- label
- 1
- 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
- interventionNames
- Drug: Risedronate
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAdams 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. PMID 38979716