Clinical trial · Interventional
Risedronate in Improving Bone Mineral Density and Bone Health in Postmenopausal Women With Ductal Carcinoma In Situ Enrolled in Clinical Trial CRUK-IBIS-II-DCIS
A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Bone Biomarkers of Anastrozole When Used to Prevent Breast Cancer in Postmenopausal Women
- 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)
RATIONALE: Bisphosphonates, such as risedronate, may help improve bone health and prevent osteoporosis in postmenopausal women. It is not yet known whether risedronate is effective in improving bone mineral density and bone health in women with ductal carcinoma in situ. PURPOSE: This randomized phase III trial is studying risedronate to see how well it works compared to a placebo in improving bone mineral density and bone health in postmenopausal women with ductal carcinoma in situ enrolled in clinical trial CRUK-IBIS-II-DCIS (CRUK: Cancer Research UK) (DCIS: Ductal carcinoma in situ).
Conditions
Conditions (2)
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 |
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| diagnostic laboratory biomarker analysis | Other | — | UNRESOLVED |
| risedronate sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Spine and femur bone change comparison
- measure
- Effects of bisphosphonate on bone mineral density and bone metabolism in patients who were osteoporotic or moderately severe osteopenic at baseline
Secondary outcomes (1)
- measure
- Correlation of changes in levels of biochemical markers of bone metabolism with longer-term changes in bone mineral density as measured by dual-energy x-ray absorptiometry (DXA)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of ductal carcinoma in situ within the past 6 months
* Locally excised with tumor-free margins at least 1 mm
* Currently enrolled in protocol CRUK-IBIS-II-DCIS AND randomized to receive either anastrozole or placebo
* No T-score \< -4.0 and/or \> 2 low trauma vertebral fractures by dual-energy x-ray absorptiometry (DXA)
* Hormone receptor status: Estrogen or progesterone receptor positive tumor
PATIENT CHARACTERISTICS:
* Female patient
* Postmenopausal
* No prior bilateral hip fracture or bilateral hip prostheses
* No concurrent metabolic bone disease, including any of the following:
* Paget's disease
* Osteogenesis imperfecta
* Disorders of calcium or mineral metabolism
* Renal calculus
* Malabsorption
* Hypercalcemia or hypocalcemia
* Hyperparathyroidism or hypoparathyroidism
* Hyperthyroidism or hypothyroidism
* Patients on stable replacement therapy are allowed provided they are euthyroid
PRIOR CONCURRENT THERAPY:
* More than 12 months since prior medication affecting bone metabolism, including any of the following:
* Estrogen
* Any bisphosphonate
* Parathyroid hormone
* Calcitonin
* Oral or systemic glucocorticoidsReferences
Publications (2)
- RESULTSingh S, Cuzick J, Edwards R, et al.: Effect of anastrozole on bone mineral density after one year of treatment: results from bone sub-study of the International Breast Cancer Intervention Study (IBIS-II). [Abstract] Breast Cancer Res Treat 106 (1): A-28, S9, 2007.
- 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