Risedronate in Improving Bone Mineral Density and Bone Health in Postmenopausal Women With Ductal Carcinoma In Situ Enrolled in Clinical Trial CRUK-IBIS-II-DCIS

Last updated: November 28, 2012
Sponsor: International Breast Cancer Study Group
Overall Status: Trial Not Available

Phase

3

Condition

Osteoporosis

Precancerous Condition

Genitourinary Cancer

Treatment

N/A

Clinical Study ID

NCT00324714
CDR0000474949
IBCSG-31-03-PBS
EUDRACT-2004-003991-12
  • Ages 40-70
  • Female

Study 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).

Eligibility Criteria

Inclusion

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

Study Design

Study Start date:
February 01, 2003
Estimated Completion Date:

Study Description

OBJECTIVES:

Primary

  • Compare the changes in bone of the spine and femur in postmenopausal women with ductal carcinoma in situ treated with anastrozole vs placebo on protocol CRUK-IBIS-II-DCIS.

  • Determine the effect of bisphosphonate treatment on bone mineral density and bone metabolism in patients who are receiving anastrozole on protocol CRUK-IBIS-II-DCIS and are osteoporotic or moderately to severely osteopenic at baseline.

Secondary

  • Correlate 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).

OUTLINE: This is a multicenter, partially randomized, double-blind study. Patients are stratified according to bone mineral density (T-score) measurements (≥ -1.5 vs -2.5 to < -1.5 vs -4.0 to < -2.5 or ≤ 2 low-trauma vertebral fractures). Patients in stratum I are further stratified according to calcium and cholecalciferol (vitamin D) supplementation (yes vs no) and use of risedronate on this study (yes vs no). Patients in stratum II are further stratified according to randomized treatment on protocol CRUK-IBIS-II-DCIS (yes vs no).

  • Stratum I (T-score ≥ -1.5): Patients undergo dual-energy x-ray absorptiometry (DXA) scanning at baseline and then at 1, 3, 5, and 7 years. Patients who develop osteoporosis (T-score < -2.5) are removed from the study and receive open-label bisphosphonates.

  • Stratum II (T-score -2.5 to < -1.5 [moderate to severe osteopenia]): Patients undergo DXA scanning as in stratum I. Patients are also randomized (double-blind) to 1 of 2 treatment arms.

    • Arm I: Patients receive oral risedronate once a week for 5 years.

    • Arm II: Patients receive oral placebo once a week for 5 years. Patients in either arm who develop osteoporosis AND a drop in T-score of more than 1 unit are removed from the study and receive open-label bisphosphonates.

  • Stratum III (T-score -4.0 to < -2.5 OR ≤ 2 low trauma vertebral fractures [osteoporosis]): Patients undergo DXA scanning as in stratum I. Patients also receive oral risedronate (or their current bisphosphonate) once a week for 5 years.

Blood samples for correlative studies (e.g., bone biomarkers, serum estradiol) are collected at baseline and at 6 and 12 months.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.

Connect with a study center

  • Inselspital Bern

    Bern, CH-3010
    Switzerland

    Site Not Available

  • Oncocare Sonnenhof-Klinik Engeriedspital

    Bern, CH-3012
    Switzerland

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.