Healia Clinical Trials Information Database

Prevention of Osteoporosis in Breast Cancer Survivors

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.

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.

Status: Completed (Phase 4). Started on April 1st, 2002. Ended on December 1st, 2007.

Enrollment: 249 subjects

Study Type: Interventional

Study Design:

  • Prevention
  • Randomized
  • Open Label
  • Parallel Assignment

Conditions:

Interventions:

  • Other: risedronate, calcium/vit D, strength weight training (Actonel 35 mg.)

Eligibility

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.

Gender

Female

Mininum Age

35 Years

Maximum Age

75 Years

Healthy Volunteers

No


Resources

Source: University of Nebraska

Authority: United States: Institutional Review Board

Locations

  • University of Nebraska Medical Center, College of Nursing
    Lincoln
    Nebraska
    68588-0220
    United States
  • University of Nebraska Medical Center, College of Nursing
    Kearney
    Nebraska
    68849-4510
    United States
  • University of Nebraska Medical Center, College of Nursing
    Omaha
    Nebraska
    68198-5330
    United States
  • University of Nebraska Medical Center, College of Nursing
    Scottsbluff
    Nebraska
    69361-4939
    United States

Officials

  • Nancy L Waltman, PhD, ARNP (Principal Investigator, University of Nebraska Medical Center, College of Nursing)

Sponsors

  • University of Nebraska (Lead Sponsor)

References

None.

Links

None.


Date Verified
December 1st, 2007
First Received
December 27th, 2007
Last Changed
December 27th, 2007

Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.


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The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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