Prevention of Osteoporosis in Breast Cancer Survivors
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

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.
    

Intervention name(s): Strength/Weight Training & Drug/Supplement; Drug/Supplement only
Intervention type(s): Other; Combination Product
Intervention description(s): 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 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.
Other intervention name(s): Actonel; Actonel
Intervention MeSH terms: Risedronic Acid; Etidronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention