Bisphosphonate and Anastrozole Trial - Bone Maintenance Algorithm Assessment - Full Text View

Sponsors and Collaborators:	Barwon Health AstraZeneca
Information provided by:	Barwon Health
ClinicalTrials.gov Identifier:	NCT00122356

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Alendronate sodium	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Osteoporosis

Drug Information available for: Alendronate Alendronate sodium Anastrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Barwon Health:

Primary Outcome Measures:

Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD [ Time Frame: 12 monthly intervals ] [ Designated as safety issue: Yes ]
Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD [ Time Frame: 6 months after registration and/or 6 months after commencing alendronate ] [ Designated as safety issue: No ]
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Evaluate the clinical fracture incidence cumulative over 5 years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Perform an economic analysis of the cost of monitoring and intervention [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	September 2005
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Intervention Details:

70mg tablets, once weekly

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122356

Contacts

Contact: Elaine Yeow, BSc, MHumNutr

61-3-52267858

elainey@barwonhealth.org.au

Locations

Australia, New South Wales
Sydney Cancer Institute	Recruiting
Sydney, New South Wales, Australia, 2050
Principal Investigator: Jane Beith
Tweed Hospital	Recruiting
Tweed Heads, New South Wales, Australia, 2485
Principal Investigator: Ehtesham Abdi
Australia, Victoria
Barwon Health	Recruiting
Geelong, Victoria, Australia, 3220
Contact: Elaine Yeow 61-3-52267858 elainey@barwonhealth.org.au
Principal Investigator: Richard Bell
Maroondah Breast Clinic	Recruiting
East Ringwood, Victoria, Australia, 3135
Principal Investigator: Jacquie Chirgwin
St John of God Healthcare	Recruiting
Geelong, Victoria, Australia, 3220
Sub-Investigator: Karen White
Box Hill Hospital	Recruiting
Box Hill, Victoria, Australia, 3128
Principal Investigator: Jacquie Chirgwin
St Vincent's Health	Recruiting
Fitzroy, Victoria, Australia, 3065
Principal Investigator: Raymond Snyder

Sponsors and Collaborators

Barwon Health

AstraZeneca

Investigators

Principal Investigator:

Richard Bell, MBBS (Hons)

Barwon Health

More Information

Responsible Party:	Barwon Health ( Associate Professor Richard Bell )
Study ID Numbers:	ALCC 04.02
Study First Received:	July 20, 2005
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00122356
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Anastrozole
Diphosphonates
Skin Diseases
Alendronate

Osteoporosis
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Enzyme Inhibitors
Bone Density Conservation Agents
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009