Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00082277

Purpose

The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.

Condition	Intervention	Phase
Breast Cancer	Drug: Anastrozole Drug: Risedronate Sodium	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-Receptor-Positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum; Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum; Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum)Abbreviated

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Fractures Minerals

Drug Information available for: Risedronic acid Risedronate sodium Anastrozole

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in total hip BMD [ Time Frame: Assessed at 12 and 24 months ] [ Designated as safety issue: No ]
Change from baseline in lumbar spine (L1-L4) BMD [ Time Frame: Assessed at 24 months ] [ Designated as safety issue: No ]
Change from baseline in bone formation markers [ Time Frame: Assessed at 6 and12 months ] [ Designated as safety issue: No ]
Change from baseline in bone resorption and formation markers [ Time Frame: Assessed at 6 and 12 months ] [ Designated as safety issue: No ]
Change from baseline in LDL-cholesterol [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ]
Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides [ Time Frame: Assessed at 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment:	237
Study Start Date:	October 2002
Study Completion Date:	November 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum	Drug: Anastrozole 1mg/Day Oral Drug: Risedronate Sodium 35mg/week, oral
2: Experimental Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum	Drug: Anastrozole 1mg/Day Oral Drug: Risedronate Sodium 35mg/week, oral
3: Experimental Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum	Drug: Anastrozole 1mg/Day Oral Drug: Risedronate Sodium 35mg/week, oral

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women defined as Postmenopausal
Histologically proven operable invasive breast cancer
Hormone-receptor-positive breast cancer

Exclusion Criteria:

Clinical evidence of metastatic disease
Bilateral hip fractures or bilateral hip prosthesis
Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens
Malabsorption syndrome

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082277

Show 35 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Arimidex Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Francisco Sapunar, MD - Arimidex Medical Science Director )
Study ID Numbers:	D5392C00050, SABRE
Study First Received:	May 5, 2004
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00082277 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

hormone-receptor positive, breast cancer
Osteopenia
Osteoporosis
risk of fracture
bone loss

Additional relevant MeSH terms:

Anastrozole
Etidronic Acid
Antineoplastic Agents, Hormonal
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Calcium Channel Blockers
Breast Neoplasms
Enzyme Inhibitors

Bone Density Conservation Agents
Cardiovascular Agents
Hormones
Pharmacologic Actions
Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases
Risedronic acid

ClinicalTrials.gov processed this record on November 05, 2009