Prevention of Osteoporosis in Breast Cancer Survivors

This study has been completed.
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00567606
First received: December 3, 2007
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Postmenopausal Osteoporosis
Other: risedronate, calcium/vit D, strength weight training
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Osteoporosis in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Bone Mineral Density (gm/cm2) will be measured by Dual-Energy X-ray Absorptiometry (DEXA) of the hip, spine and forearm [ Time Frame: at 12, 24, and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle Strength (peak torque/body weight at 60 degrees) will be assessed using BiodexTM Velocity Spectrum Evaluation (Medical Systems, Inc., 1993) [ Time Frame: at baseline, 6, 12, 24, and 36 months ] [ Designated as safety issue: No ]

Enrollment: 249
Study Start Date: April 2002
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: 1
Subjects in the G1 group receive 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.
Other: risedronate, calcium/vit D, strength weight training
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. G2 group receives the calcium, vitamin D, and risedronate, but do not participate in strength/weight training exercises.
Other Name: Actonel 35 mg.
Experimental: 2
Subjects in the G2 group receive the calcium, vitamin D, and risedronate, but do not participate in strength/weight training exercises.
Other: risedronate, calcium/vit D, strength weight training
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. G2 group receives the calcium, vitamin D, and risedronate, but do not participate in strength/weight training exercises.
Other Name: Actonel 35 mg.

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

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567606

Locations
United States, Nebraska
University of Nebraska Medical Center, College of Nursing
Kearney, Nebraska, United States, 68849-4510
University of Nebraska Medical Center, College of Nursing
Lincoln, Nebraska, United States, 68588-0220
University of Nebraska Medical Center, College of Nursing
Omaha, Nebraska, United States, 68198-5330
University of Nebraska Medical Center, College of Nursing
Scottsbluff, Nebraska, United States, 69361-4939
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Nancy L Waltman, PhD, ARNP University of Nebraska Medical Center, College of Nursing
  More Information

Publications:
Responsible Party: Nancy Waltman, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00567606     History of Changes
Other Study ID Numbers: 536-01-FB, 1 R01 NR07743-04
Study First Received: December 3, 2007
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Osteoporosis, Postmenopausal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014