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The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)


N/A
18 Years
N/A
Not Enrolling
Female
Osteoporosis

Thank you

Trial Information

The Prevention of Osteoporosis in Premenopausal and Newly Postmenopausal (Up to 8 Years) Women With Breast Cancer Following Chemotherapy (REBBeCA Study)


Breast cancer is a significant public health problem accounting for approximately 30% of new
cancers diagnosed annually. Much advancement has been made in the treatment of these cancers
which has significantly decreased the mortality rates. Treatment, including adjuvant
chemotherapy and hormonal therapy, prolongs disease free survival and overall survival of
patients with breast cancer. The cytotoxic drugs, however, can cause premature ovarian
failure and subsequent menopause. This risk has been reported to range from 53% to 89%.
Temporary or permanent chemotherapy induced ovarian failure is important because of
potential bone loss associated with the estrogen loss. Initiating a potent antiresorptive
agent, risedronate, should prevent or improve bone mass in these women.

Comparison: The investigators will compare bone mass/markers of study subjects receiving
risedronate with study subjects receiving placebo. All subjects will be provided calcium and
vitamin D supplementation as needed.


Inclusion Criteria:



- Pre- and newly postmenopausal (up to 8 years) women ages 18 and older

- Breast cancer treated with chemotherapeutic agents, with or without
tamoxifen/aromatase inhibitors

- Negative pregnancy test

Exclusion Criteria:

- Stage 4 breast cancer

- Any illness or medications known to affect bone metabolism

- History of osteoporosis or history of vertebral or hip fractures

- Kidney stones in the past 5 years

- Active peptic ulcer disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

That bone loss, as determined through BMD every six months, will be prevented at clinically relevant sites, such as the hip & spine, through the use of bisphosphonate therapy in study subjects.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Susan L Greenspan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Institutional Review Board

Study ID:

IRB#0404173

NCT ID:

NCT00118508

Start Date:

May 2003

Completion Date:

July 2006

Related Keywords:

  • Osteoporosis
  • Breast Neoplasms
  • Osteoporosis

Name

Location

University of Pittsburgh Medical Center (GCRC)Pittsburgh, Pennsylvania  15213