Clinical trial NCT00122356: Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Barwon Health
Sponsor class: OTHER_GOV
Collaborators: name: AstraZeneca
First posted: 2005-07-22
Enrollment: 303
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
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:
measure: Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD
timeFrame: 12 monthly intervals
measure: Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD
timeFrame: 6 months after registration and/or 6 months after commencing alendronate
measure: Evaluate the Osteoporosis Australia strategy for bone protection for this patient group
timeFrame: 5 years
measure: Evaluate the clinical fracture incidence cumulative over 5 years
timeFrame: 5 years
measure: Perform an economic analysis of the cost of monitoring and intervention
timeFrame: 5 years
measure: Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy
timeFrame: 5 years
measure: Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney South West Area Health Service
state: New South Wales
city: Tweed Heads
country: Australia
facility: Tweed Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: East Ringwood
country: Australia
facility: Maroondah Breast Clinic
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Health
state: Victoria
city: Geelong
country: Australia
facility: Barwon Health
state: Victoria
city: Geelong
country: Australia
facility: St John of God Healthcare
state: Victoria
city: Warrnambool
country: Australia
facility: South West Healthcare
state: Victoria
Study officials:
affiliation: Barwon Health
name: Karen White
role: PRINCIPAL_INVESTIGATOR
References: