Clinical trial NCT00567606: Prevention of Osteoporosis in Breast Cancer Survivors
Official title: Prevention of Osteoporosis in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Osteoporosis
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2007-12-05
Enrollment: 249
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Bone Mineral Density
timeFrame: at 12, 24, and 36 months
Secondary outcomes:
measure: Muscle Strength
timeFrame: at baseline, 6, 12, 24, and 36 months
Other outcomes:
Locations:
city: Kearney
country: United States
facility: University of Nebraska Medical Center, College of Nursing
state: Nebraska
city: Lincoln
country: United States
facility: University of Nebraska Medical Center, College of Nursing
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center, College of Nursing
state: Nebraska
city: Scottsbluff
country: United States
facility: University of Nebraska Medical Center, College of Nursing
state: Nebraska
Study officials:
affiliation: University of Nebraska Medical Center, College of Nursing
name: Nancy L Waltman, PhD, ARNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.