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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118508
• Other study ID #: IRB#0404173
• Status: Completed
• Phase: N/A
• First received: June 30, 2005
• Last updated: August 10, 2015
• Start date: May 2003
• Est. completion date: July 2006

Study information

• Verified date: August 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of once weekly risedronate in the prevention and treatment of bone loss in premenopausal and newly menopausal women with breast cancer who have received chemotherapy.

The hypothesis is that bisphosphonate therapy will prevent bone loss at clinically relevant sites, such as the hip and spine. The investigators also hypothesize that there will be a correlation between biochemical markers of bone turnover and changes in bone mineral density.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• risedronate (including placebo)
risedronate 35mg weekly

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center (GCRC)	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Aventis Pharmaceuticals, Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		24 months	No
Secondary	There will be a correlation between biochemical markers of bone turnover and changes in BMD.		24 months	No