Clinical trial · Interventional
Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
Maintaining Skeletal Health in Postmenopausal Women With Surgically Resected Stage I-IIIa Hormone-receptor Positive Breast Cancer Who Are Receiving Anastrozole, Through the Use of Alendronate as Determined by the Osteoporosis Australia Bone Maintenance Algorithm
NCT00122356CI-TRIAL-00009705BATMANcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alendronate sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Anastrozole and alendronate
- description
- Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.
- interventionNames
- Drug: Alendronate sodium
Primary outcomes (1)
- measure
- Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
- timeFrame
- 5 years
Secondary outcomes (7)
- measure
- Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
- timeFrame
- 12 monthly intervals
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal * Adequately diagnosed and treated Stage I-IIIa early breast cancer * Oestrogen receptor and/or progesterone receptor positive breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Hormone replacement therapy (HRT) must be discontinued at least 2 weeks prior to registration * Any prior tamoxifen taken for a total of 8 weeks or less * Any prior anastrozole taken for a total of 4 weeks or less * Anastrozole is clinically indicated to be the best adjuvant strategy * Signed written informed consent Exclusion Criteria: * Clinical or radiological evidence of distant spread of disease * Prior treatment with bisphosphonates within the past 12 months * Prior treatment with continuous systemic corticosteroids within the past 12 months * Prior use of parathyroid hormone for more than 1 week * Prior use of systemic sodium fluoride for \> 3 months during the past 2 years * Currently treated with any drugs known to affect the skeleton * Abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/L) * History of diseases with influence on bone metabolism. Patients with lactose intolerance are also excluded * Delayed oesophageal emptying such as stricture or achalasia * Hypersensitivity to alendronate or anastrozole * Previous or concomitant malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix * AST/SGOT and/or ALT/SGPT \> 3 x ULN in combination with other laboratory and clinical abnormalities indicating liver insufficiency * Fracture due to minimal trauma, demonstrated radiologically
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