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| Sponsor: | University of Nebraska |
|---|---|
| Information provided by: | University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT00567606 |
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 IV |
| 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 |
| 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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Nancy L Waltman, PhD, ARNP | University of Nebraska Medical Center, College of Nursing |
More Information
| 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 |
|
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 |