Ghent University Academic Bibliography

Advanced

A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture

Santiago Palacios, Stuart L Silverman, Tobie J de Villiers, Amy B Levine, STEFAN GOEMAERE, Jacques P Brown, Fiorenzo De Cicco Nardone, Robert Williams, Teresa L Hines, Sebastian Mirkin, et al. (2015) MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY. 22(8). p.806-813
abstract
Objective: In a 3-year randomized, double-blind, osteoporosis treatment study (N = 7,492), bazedoxifene 20 mg and bazedoxifene 40 mg significantly (P < 0.05) reduced the risk of new vertebral fractures by 42% and 37%, respectively, compared with placebo in postmenopausal women with osteoporosis. This study evaluated the long-term (7-y) efficacy and safety of bazedoxifene in generally healthy postmenopausal women with osteoporosis. Methods: This was a second 2-year extension of the 3-year multicenter outpatient core study. During extension I (years 4-5), women receiving bazedoxifene 40 mg transitioned to bazedoxifene 20 mg. In extension II (years 6-7; N = 1,530), all bazedoxifene-treated women continued bazedoxifene 20 mg. Main outcome measures included year 7 endpoints: incidences of new vertebral and nonvertebral fractures, bone mineral density changes, and safety assessments. Results: At 7 years, the cumulative incidences of new vertebral fractures were significantly lower in the bazedoxifene (6.4%) and bazedoxifene 20 mg (7.6%) groups than in the placebo group (9.9%); the relative risk reductions were 36.5% and 30.4%, respectively (both P < 0.001). Bazedoxifene had no effect on the overall incidence of nonvertebral fractures (bazedoxifene, 11.2%; bazedoxifene 20 mg, 12.0%; placebo, 10.8%). The mean changes from baseline in lumbar spine bone mineral density were 2.95%, 2.73%, and 2.19%, respectively. Seven-year decreases in total hip bone mineral density were significantly smaller in the bazedoxifene (-1.15%) and bazedoxifene 20 mg (-1.19%) groups than in the placebo group (-2.53%; P 0.002). Bazedoxifene showed a favorable safety/tolerability profile across 7 years, with similar adverse events, serious adverse events, and study discontinuations in all groups. Conclusions: Efficacy and safety of bazedoxifene are sustained across 7 years in postmenopausal women with osteoporosis.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
Fracture, Osteoporosis, Bazedoxifene, Selective estrogen receptor modulator, Bone mineral density, CONTINUING OUTCOMES RELEVANT, ESTROGEN-RECEPTOR MODULATOR, VERTEBRAL FRACTURE, CLINICAL-TRIAL, CONTROLLED PHASE-3, BREAST-CANCER, DOUBLE-BLIND, RISK, RALOXIFENE, RISEDRONATE
journal title
MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY
Menopause-J. N. Am. Menopause Soc.
volume
22
issue
8
pages
806 - 813
Web of Science type
Article
Web of Science id
000359850500004
JCR category
OBSTETRICS & GYNECOLOGY
JCR impact factor
3.172 (2015)
JCR rank
10/80 (2015)
JCR quartile
1 (2015)
ISSN
1072-3714
DOI
10.1097/gme.0000000000000419
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
7104804
handle
http://hdl.handle.net/1854/LU-7104804
date created
2016-02-26 16:48:37
date last changed
2016-12-19 15:47:38
@article{7104804,
  abstract     = {Objective: In a 3-year randomized, double-blind, osteoporosis treatment study (N = 7,492), bazedoxifene 20 mg and bazedoxifene 40 mg significantly (P {\textlangle} 0.05) reduced the risk of new vertebral fractures by 42\% and 37\%, respectively, compared with placebo in postmenopausal women with osteoporosis. This study evaluated the long-term (7-y) efficacy and safety of bazedoxifene in generally healthy postmenopausal women with osteoporosis. 
Methods: This was a second 2-year extension of the 3-year multicenter outpatient core study. During extension I (years 4-5), women receiving bazedoxifene 40 mg transitioned to bazedoxifene 20 mg. In extension II (years 6-7; N = 1,530), all bazedoxifene-treated women continued bazedoxifene 20 mg. Main outcome measures included year 7 endpoints: incidences of new vertebral and nonvertebral fractures, bone mineral density changes, and safety assessments. 
Results: At 7 years, the cumulative incidences of new vertebral fractures were significantly lower in the bazedoxifene (6.4\%) and bazedoxifene 20 mg (7.6\%) groups than in the placebo group (9.9\%); the relative risk reductions were 36.5\% and 30.4\%, respectively (both P {\textlangle} 0.001). Bazedoxifene had no effect on the overall incidence of nonvertebral fractures (bazedoxifene, 11.2\%; bazedoxifene 20 mg, 12.0\%; placebo, 10.8\%). The mean changes from baseline in lumbar spine bone mineral density were 2.95\%, 2.73\%, and 2.19\%, respectively. Seven-year decreases in total hip bone mineral density were significantly smaller in the bazedoxifene (-1.15\%) and bazedoxifene 20 mg (-1.19\%) groups than in the placebo group (-2.53\%; P 0.002). Bazedoxifene showed a favorable safety/tolerability profile across 7 years, with similar adverse events, serious adverse events, and study discontinuations in all groups. 
Conclusions: Efficacy and safety of bazedoxifene are sustained across 7 years in postmenopausal women with osteoporosis.},
  author       = {Palacios, Santiago and Silverman, Stuart L and de Villiers, Tobie J and Levine, Amy B and GOEMAERE, STEFAN and Brown, Jacques P and De Cicco Nardone, Fiorenzo and Williams, Robert and Hines, Teresa L and Mirkin, Sebastian and Chines, Arkadi A},
  issn         = {1072-3714},
  journal      = {MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY},
  keyword      = {Fracture,Osteoporosis,Bazedoxifene,Selective estrogen receptor modulator,Bone mineral density,CONTINUING OUTCOMES RELEVANT,ESTROGEN-RECEPTOR MODULATOR,VERTEBRAL FRACTURE,CLINICAL-TRIAL,CONTROLLED PHASE-3,BREAST-CANCER,DOUBLE-BLIND,RISK,RALOXIFENE,RISEDRONATE},
  language     = {eng},
  number       = {8},
  pages        = {806--813},
  title        = {A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture},
  url          = {http://dx.doi.org/10.1097/gme.0000000000000419},
  volume       = {22},
  year         = {2015},
}

Chicago
Palacios, Santiago, Stuart L Silverman, Tobie J de Villiers, Amy B Levine, Stefan Goemaere, Jacques P Brown, Fiorenzo De Cicco Nardone, et al. 2015. “A 7-year Randomized, Placebo-controlled Trial Assessing the Long-term Efficacy and Safety of Bazedoxifene in Postmenopausal Women with Osteoporosis: Effects on Bone Density and Fracture.” Menopause-the Journal of the North American Menopause Society 22 (8): 806–813.
APA
Palacios, S., Silverman, S. L., de Villiers, T. J., Levine, A. B., Goemaere, S., Brown, J. P., De Cicco Nardone, F., et al. (2015). A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture. MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY, 22(8), 806–813.
Vancouver
1.
Palacios S, Silverman SL, de Villiers TJ, Levine AB, Goemaere S, Brown JP, et al. A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture. MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY. 2015;22(8):806–13.
MLA
Palacios, Santiago, Stuart L Silverman, Tobie J de Villiers, et al. “A 7-year Randomized, Placebo-controlled Trial Assessing the Long-term Efficacy and Safety of Bazedoxifene in Postmenopausal Women with Osteoporosis: Effects on Bone Density and Fracture.” MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY 22.8 (2015): 806–813. Print.