Prevention of Osteoporosis in Breast Cancer Survivors

NCT ID: NCT00567606

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 249 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-01
• Study Completion Date: 2007-12-01

Brief Summary

The purpose of this study is to test whether strength/weight training exercises enhance the effectiveness of calcium, vitamin D, and risedronate for the prevention and treatment of osteoporosis in postmenopausal breast cancer survivors.

Detailed Description

Each year, more than 192,200 women are diagnosed with breast cancer (Greenlee, Hill-Harmon, Murray, & Thun, 2001). With an increase in early detection and improved therapies, more of these women have become survivors (Vassilopoulou-Sellin & Theriault, 1994). However, many of these women are at increased risk for osteoporosis and the debilitating consequences. This increased risk occurs for two reasons. Over 50-70% of women under the age of 50 (premenopausal) who are treated with adjuvant chemotherapy experience ovarian failure and early menopause (Ali & Twibel, 1994; Cobleigh et al., 1994; Samaan et al., 1978), resulting in a long postmenopausal period of estrogen deprivation. Breast cancer survivors also are at greater risk for osteoporosis because they usually are not candidates for hormone replacement therapy (HRT). Estrogen can influence the growth of cancer in women, especially those with estrogen receptor positive tumors (ER+), and at least 60% of women have ER+ breast cancer (DeVita, Hellman & Rosenberg, 1997). While the use of HRT significantly reduces osteoporosis and the risk of forearm, vertebral, pelvic, and hip fractures in postmenopausal women (Cobleigh et al., 1994; Finkelstein, 1996), women with a history of breast cancer generally are not considered candidates for HRT. Without estrogen, women may lose up to 30% of their bone mass within the first 5-years postmenopause, with continued bone loss over time, but at a slower rate. Very little information has been reported on the incidence and treatment of osteoporosis in breast cancer survivors (Headley et al., 1998; Hosking et al., 1998).

Osteoporosis is a major risk factor for chronic disability and especially hip fractures. The majority of individuals with hip fractures never return to prefracture functional status and estimates of health care costs for individuals with osteoporosis exceed the costs for those with congestive heart failure or with asthma (U.S. Congress Office of Technology Assessment, 1994; Ray, Chan, Thamer & Meltin, 1997). Prevention and treatment of osteoporosis, by increasing bone mineral density (BMD) and muscle strength, may decrease the chronic disabilities associated with osteoporosis and improve quality and quantity of life (Mahon, 1998). Research on effective alternatives to HRT for the prevention of osteoporosis in breast cancer survivors has been targeted as a priority area by the Office of Cancer Survivorship (Division of Cancer Control and Population Sciences) at the National Cancer Institute (Office of Cancer Survivorship, 1999). No reports were found in which the effectiveness of the combination of risedronate, calcium, and vitamin D (administered together and at the current recommended levels for postmenopausal women) was studied, nor has the effectiveness of the addition of long term progressive strength/weight training exercises been evaluated in this at risk population of breast cancer survivors.

Conditions

Postmenopausal Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Strength/Weight Training

Subjects in the G1 group receive drug/supplement combination and strength/weight training exercises for upper and lower extremities and the spine.

Group Type: EXPERIMENTAL

Strength/Weight Training & Drug/Supplement

Intervention Type: OTHER

G1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine.

Drug Supplement only

Subjects in the G2 group receive drug/supplement combination, but do not participate in strength/weight training exercises.

Group Type: EXPERIMENTAL

Drug/Supplement only

Intervention Type: COMBINATION_PRODUCT

G2 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week, but do not participate in strength/weight training exercises.

Interventions

Strength/Weight Training & Drug/Supplement

G1 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week and strength/weight training exercises for upper and lower extremities and the spine.

Intervention Type: OTHER

Drug/Supplement only

G2 group receives 1200 mg of calcium and 400 IU of vitamin D supplements per day, 35 mg of risedronate per week, but do not participate in strength/weight training exercises.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Actonel; Actonel

Eligibility Criteria

Inclusion Criteria

• read, speak and understand English;
• be female;
• be between the ages of 35 and 75;
• have completed treatment (except tamoxifen) for stage 0, I or II breast cancer (i.e. surgery, chemotherapy, radiation) at least 6 months prior to admission to the study;
• be 1 year postmenopausal (12-months amenorrheic; subjects 55-years or younger with history of hysterectomy without oophorectomy must have it confirmed by two baseline measures of FSH >40 IU/ml);
• have a BMD T-score of -1.0 SD or lower at one or more sites (spine, hip or forearm); and
• have agreement of their primary care provider for participation in the study.

Exclusion Criteria

• have a recurrence of their breast cancer;
• currently take hormone replacement therapy, bisphosphonates, calcitonin, raloxifene, calcitriol, or glucocorticosteroids.;
• currently do strength/weight training exercises or high impact exercises (such as running, jumping rope, high impact aerobic dance, martial arts, volleyball, or basketball) two to three times weekly;
• have a body mass index (BMI) equal to or greater than 35;
• have serum calcium, creatinine or TSH (if on thyroid therapy) outside the normal limits;
• have active gastrointestinal problems such as dysphagia, esophageal disease, gastritis, duodenitis, or ulcers;
• have Paget=s disease;
• have renal disease (renal stones or serum creatinine levels greater than the upper normal limits);
• have a recent history of a spinal fracture (within the past 6 months);
• have features of an acute fracture on baseline spinal x-rays;
• have other concomitant conditions that prohibit strength/weight training exercises, calcium, or vitamin D intake.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy L Waltman, PhD, ARNP

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska Medical Center, College of Nursing

Locations

University of Nebraska Medical Center, College of Nursing

Kearney, Nebraska, United States

University of Nebraska Medical Center, College of Nursing

Lincoln, Nebraska, United States

University of Nebraska Medical Center, College of Nursing

Omaha, Nebraska, United States

University of Nebraska Medical Center, College of Nursing

Scottsbluff, Nebraska, United States

Countries

United States

References

Twiss JJ, Gross GJ, Waltman NL, Ott CD, Lindsey AM. Health behaviors in breast cancer survivors experiencing bone loss. J Am Acad Nurse Pract. 2006 Oct;18(10):471-81. doi: 10.1111/j.1745-7599.2006.00165.x.

Reference Type: RESULT

PMID: 16999712 (View on PubMed)

Ott CD, Twiss JJ, Waltman NL, Gross GJ, Lindsey AM. Challenges of recruitment of breast cancer survivors to a randomized clinical trial for osteoporosis prevention. Cancer Nurs. 2006 Jan-Feb;29(1):21-31, quiz 32-3. doi: 10.1097/00002820-200601000-00004.

Reference Type: RESULT

PMID: 16557117 (View on PubMed)

Other Identifiers

1R01NR007743-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0536-01-FB

Identifier Type: -

Identifier Source: org_study_id