Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: Results of a 5-year, randomized, placebo-controlled study
Osteoporosis International,  Clinical Article

Silverman SL et al. – The findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women.

Methods

  • 4,216 postmenopausal women with osteoporosis enrolled
  • 2-year extension of 3-year, randomized, double-blind, placebo-controlled, phase 3 trial
  • In core study (N=7,492), subjects received bazedoxifene 20 or 40 mg/day, raloxifene 60 mg/day, or placebo
  • Raloxifene arm was discontinued after 3 years; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years
  • 5-year findings reported for bazedoxifene 20 and 40/20 mg and placebo
  • Endpoints included incidence of new vertebral fractures (primary) and non-vertebral fractures, and changes in BMD and bone turnover markers

Results
  • At 5 years, the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg (4.5%) and 40/20 mg (3.9%) versus placebo (6.8%; P<0.05), with relative risk reductions of 35% and 40%
  • Non-vertebral fracture incidence was similar among groups
  • In a subgroup of higher-risk women (n=1,324; femoral neck T-score ≤-3.0 and/or ≥1 moderate or severe or ≥2 mild vertebral fracture[s]), bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo (37%; P=0.06); combined data for bazedoxifene 20 and 40/20 mg reached statistical significance (34% reduction; P<0.05)
  • Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo (P<0.05) and was generally safe and well tolerated

Please login or register to follow this author.
Are you sure you want to Unfollow this Author?
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

Your Unread Messages in Rheumatology

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Rheumatology Articles

1 Homeopathy in the treatment of fibromyalgia- A comprehensive literature-review and meta-analysis Complementary Therapies in Medicine, August 15, 2014    Evidence Based Medicine    Review Article

2 Lupus classification criteria expanded; treat-to-target approach gains support Full Text The Rheumatologist, July 24, 2014    Free full text

3 Rituximab for the treatment of relapses in ANCA-associated vasculitis Arthritis & Rheumatism, August 1, 2014    Clinical Article

4 Oral bisphosphonate use and total knee/hip implant survival: Validation of results in an external population-based cohort Arthritis & Rheumatism, August 14, 2014    Clinical Article

5 Gout, urate lowering therapy and uric acid levels among US adults Arthritis Care & Research , September 16, 2014    Clinical Article

6 Frequent conversion of tuberculosis screening tests during anti-tumour necrosis factor therapy in patients with rheumatic diseases Annals of Rheumatic Diseases, September 10, 2014    Clinical Article

7 Does non-erosive rheumatoid arthritis exist? a cross-sectional analysis and a systematic literature review Seminars in Arthritis and Rheumatism, September 25, 2014    Review Article

8 Valgus bracing for knee osteoarthritis: A meta-analysis of randomized trials Arthritis Care & Research , September 12, 2014    Evidence Based Medicine

9 Early predictors of prognosis in juvenile idiopathic arthritis: A systematic literature review Annals of Rheumatic Diseases, August 29, 2014    Review Article

10 Potential risk of TNF inhibitors on the progression of interstitial lung disease in patients with rheumatoid arthritis BMJ Open, September 12, 2014    Clinical Article

11 Immunosuppressive therapies for the induction treatment of proliferative lupus nephritis: A systematic review and network metaanalysis The Journal of Rheumatology, September 18, 2014    Evidence Based Medicine    Review Article

12 Adalimumab in patients with hand osteoarthritis refractory to analgesics and NSAIDs: A randomised, multicentre, double-blind, placebo-controlled trial Annals of Rheumatic Diseases, August 25, 2014    Clinical Article

13 Profound reduction in hospital admissions and musculoskeletal surgical procedures for rheumatoid arthritis with concurrent changes in clinical practice (1995-2010) Rheumatology, September 26, 2014    Clinical Article

14 Tocilizumab in rheumatoid arthritis: A case study of safety evaluations of a large postmarketing data set from multiple data sources Seminars in Arthritis and Rheumatism, September 29, 2014    Clinical Article

15 Differentiation between osteoarthritis and psoriatic arthritis: Implications for pathogenesis and treatment in the biological therapy era Rheumatology, September 22, 2014    Review Article

16 Pain management with acupuncture in osteoarthritis: a systematic review and meta-analysis Full Text BMC Complementary and Alternative Medicine, September 8, 2014    Free full text    Evidence Based Medicine    Review Article

17 Drug-associated cutaneous vasculitis: Study of 239 patients from a single referral center The Journal of Rheumatology, September 25, 2014    Clinical Article

18 “Worm pill” could ease autoimmune disease symptoms Monash University News, August 12, 2014

19 Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis (CORRA): study protocol for a randomized controlled trial Full Text Trials, September 18, 2014    Free full text    Evidence Based Medicine    Clinical Article

20 A possible link between ankylosing spondylitis and periodontitis: A systematic review and meta-analysis Rheumatology, September 16, 2014    Evidence Based Medicine    Review Article

Indexed Journals in Rheumatology: Arthritis & Rheumatism, Annals of Rheumatic Diseases, Journal of Rheumatologymore

Register now to view all the MDLinx contents (FREE)!

  • Stay current on the latest literature, research and clinical news
  • Get special communications and offers from MDLinx and our sponsors
  • Receive invitations to paid market research
View Samples and Register

Connect with us, stay current.

Receive the latest mecial news
updates for free via email

Sign up!

Subscribe to our free RSS feeds:

Get the latest news in your specialty automatically added to your newsreader or your personal My Yahoo!, Google, My MSN or My AOL page. Learn More

Close