title: Prevention of bone loss with risedronate in breast cancer survivors: a randomized, controlled clinical trial.
abstract: In postmenopausal women with low bone mass and hormone-receptor-positive breast cancer on an aromatase inhibitor, risedronate maintained skeletal health assessed by bone density and turnover markers. Women with the greatest decreases in bone turnover markers at 12 months had the greatest increases in bone density at 24 months.
  
  
  BACKGROUND
  Aromatase inhibitors (AIs), adjuvant endocrine therapy for postmenopausal women with hormone-receptor-positive breast cancer, are associated with bone loss and fractures. Our objectives were to determine if (1) oral bisphosphonate therapy can prevent bone loss in women on an AI and (2) early changes in bone turnover markers (BTM) can predict later changes in bone mineral density (BMD).
  
  
  METHODS
  We conducted a 2-year double-blind, placebo-controlled, randomized trial in 109 postmenopausal women with low bone mass on an AI (anastrozole, letrozole, or exemestane) for hormone-receptor-positive breast cancer. Participants were randomized to once weekly risedronate 35 mg or placebo, and all received calcium plus vitamin D. The main outcome measures included BMD, BTM [carboxy-terminal collagen crosslinks (CTX) and N-terminal propeptide of type 1 procollagen (P1NP)], and safety.
  
  
  RESULTS
  Eighty-seven percent completed 24 months. BMD increased more in the active treatment group compared to placebo with an adjusted difference at 24 months of 3.9 ± 0.7 percentage points at the spine and 3.2 ± 0.5 percentage points at the hip (both p < 0.05). The adjusted difference between the active treatment and placebo groups were 0.09 ± 0.04 nmol/LBCE for CTX and 23.3 ± 4.8 μg/mL for P1NP (both p < 0.05). Women with greater 12-month decreases in CTX and P1NP in the active treatment group had a greater 24-month increase in spinal BMD (p < 0.05). The oral therapy was safe and well tolerated.
  
  
  CONCLUSIONS
  In postmenopausal women with low bone mass and breast cancer on an AI, the oral bisphosphonate risedronate maintained skeletal health.
authors: Department of Medicine, University of Pittsburgh, 3471 Fifth Ave., Suite 1110, Kaufmann Bldg, Pittsburgh, PA, 15213, USA. greenspn@pitt.edu.
authors: S L
authors: SL
authors: Greenspan
authors: Department of Medicine, University of Pittsburgh, 3471 Fifth Ave., Suite 1110, Kaufmann Bldg, Pittsburgh, PA, 15213, USA.
authors: K T
authors: KT
authors: Vujevich
authors: Department of Medicine, University of Pittsburgh, 3471 Fifth Ave., Suite 1110, Kaufmann Bldg, Pittsburgh, PA, 15213, USA.
authors: A
authors: A
authors: Brufsky
authors: Department of Medicine, University of Pittsburgh, 3471 Fifth Ave., Suite 1110, Kaufmann Bldg, Pittsburgh, PA, 15213, USA.
authors: B C
authors: BC
authors: Lembersky
authors: Department of Medicine, University of Pittsburgh, 3471 Fifth Ave., Suite 1110, Kaufmann Bldg, Pittsburgh, PA, 15213, USA.
authors: G J
authors: GJ
authors: van Londen
authors: Department of Medicine, University of Pittsburgh, 3471 Fifth Ave., Suite 1110, Kaufmann Bldg, Pittsburgh, PA, 15213, USA.
authors: R C
authors: RC
authors: Jankowitz
authors: Department of Medicine, University of Pittsburgh, 3471 Fifth Ave., Suite 1110, Kaufmann Bldg, Pittsburgh, PA, 15213, USA.
authors: S L
authors: SL
authors: Puhalla
authors: Department of Medicine, University of Pittsburgh, 3471 Fifth Ave., Suite 1110, Kaufmann Bldg, Pittsburgh, PA, 15213, USA.
authors: P
authors: P
authors: Rastogi
authors: Department of Medicine, University of Pittsburgh, 3471 Fifth Ave., Suite 1110, Kaufmann Bldg, Pittsburgh, PA, 15213, USA.|Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.
authors: S
authors: S
authors: Perera
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use; D047072:Aromatase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016723:Bone Remodeling / Q000187:drug effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000139:chemically induced / Q000503:physiopathology / Q000517:prevention & control*; D000068296:Risedronic Acid / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D047072:Aromatase Inhibitors; D015415:Biomarkers; D050071:Bone Density Conservation Agents; D000068296:Risedronic Acid
keywords: Antiresorptives; Biochemical markers of bone turnover; Clinical trials; DXA