NCT00324714

Brief Summary

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

First QC Date

May 10, 2006

Last Update Submit

November 28, 2012

Conditions

Breast CancerOsteoporosis

Keywords

osteoporosisductal breast carcinoma in situbreast cancer in situ

Outcome Measures

Primary Outcomes (2)

  • Spine and femur bone change comparison

  • Effects of bisphosphonate on bone mineral density and bone metabolism in patients who were osteoporotic or moderately severe osteopenic at baseline

Secondary Outcomes (1)

  • 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)

Interventions

risedronate sodiumDRUG
diagnostic laboratory biomarker analysisOTHER

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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 glucocorticoids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Oncocare Sonnenhof-Klinik Engeriedspital

Bern, CH-3012, Switzerland

Location

Related Publications (2)

  • Singh 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.

    RESULT

  • Adams 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: 38979716DERIVED

MeSH Terms

Conditions

Breast NeoplasmsOsteoporosisCarcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Katharina S. Buser, MD

    Oncocare Sonnenhof-Klinik Engeriedspital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

February 1, 2003

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations

CH(2)