title: Prevention of osteoporosis as a consequence of aromatase inhibitor therapy in postmenopausal women with early breast cancer: rationale and design of a randomized controlled trial.
abstract: BACKGROUND
  Aromatase inhibitors (AIs) have improved the prognosis for breast cancer survivors and are now standard of care for postmenopausal women with hormone receptor positive early stage breast cancer. One side-effect, however, is a decrease in bone mineral density (BMD) and increased fracture risk. Since hormone replacement therapy (HRT) is contraindicated in these women, one prevention option is exercise combined with vitamin D and calcium. The effect of this intervention on drug-induced osteoporosis is unknown.
  
  
  METHODS
  A single-blind randomized controlled trial will be undertaken to test the hypothesis that exercise combined with vitamin D and calcium can prevent the decrease in BMD associated with the use of AIs. Sixty postmenopausal women prescribed an AI for the treatment of breast cancer will be randomized into either an exercise or control group. Participants randomized to the exercise group will undertake a 12-month gym-based exercise program, 3 times per week involving resistance and impact training. Participants in the control group will be advised on the benefits of exercise for preventing osteoporosis, but not prescribed exercise. Both groups will receive vitamin D and calcium supplements. The primary outcome will be total hip bone mineral density measured via dual energy X-ray absorptiometry (DXA). Study outcomes will be compared between groups at baseline, 6months and 12months.
  
  
  CONCLUSIONS
  This study will investigate the effect of exercise in combination with vitamin D and calcium on prevention of drug-induced osteoporosis in postmenopausal women prescribed AIs for the treatment of breast cancer.
authors.affiliation: Faculty of Health Sciences, University of Sydney, PO Box 170, Lidcombe, NSW 1825, Australia. sharon.kilbreath@sydney.edu.au
authors.forename: Sharon
authors.initials: S
authors.lastname: Kilbreath
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Refshauge
authors.forename: Jane
authors.initials: J
authors.lastname: Beith
authors.forename: Leigh
authors.initials: L
authors.lastname: Ward
authors.forename: Kate
authors.initials: K
authors.lastname: Sawkins
authors.forename: Ross
authors.initials: R
authors.lastname: Paterson
authors.forename: Philip
authors.initials: P
authors.lastname: Clifton-Bligh
authors.forename: Philip N
authors.initials: PN
authors.lastname: Sambrook
authors.forename: Judy M
authors.initials: JM
authors.lastname: Simpson
authors.forename: Liza
authors.initials: L
authors.lastname: Nery
mesh_terms: D015502:Absorptiometry, Photon; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D015519:Bone Density; D001943:Breast Neoplasms / Q000188:drug therapy*; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D010024:Osteoporosis / Q000175:diagnosis / Q000209:etiology* / Q000517:prevention & control; D017698:Postmenopause; D011379:Prognosis; D012107:Research Design; D012307:Risk Factors; D016037:Single-Blind Method; D014807:Vitamin D / Q000627:therapeutic use; D016387:Women's Health
chemical_list: D047072:Aromatase Inhibitors; D014807:Vitamin D