Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial
Bruce Ettinger,Dennis M. Black,Bruce H. Mitlak,Ronald Keith Knickerbocker,Thomas Nickelsen,Harry K. Genant,Claus Christiansen,Pierre D. Delmas,Jose R. Zanchetta,J. A. Stakkestad,Claus C. Glüer,Kathryn A. Krueger,Fredric J. Cohen,Stephen Eckert,Kristine E. Ensrud,Louis V. Avioli,Paul Lips,Steven R. Cummings +17 more
TLDR
The Multiple Outcomes of Raloxifene Evaluation (MORE) study as mentioned in this paper evaluated the effect of raloxion hydrochloride therapy on risk of vertebral and non-vertebral fractures.Abstract:
ContextRaloxifene hydrochloride, a selective estrogen receptor modulator, prevents
bone loss in postmenopausal women, but whether it reduces fracture risk in
these women is not known.ObjectiveTo determine the effect of raloxifene therapy on risk of vertebral and
nonvertebral fractures.DesignThe Multiple Outcomes of Raloxifene Evaluation (MORE) study, a multicenter,
randomized, blinded, placebo-controlled trial.Setting and ParticipantsA total of 7705 women aged 31 to 80 years in 25 countries who had been
postmenopausal for at least 2 years and who met World Health Organization
criteria for having osteoporosis. The study began in 1994 and had up to 36
months of follow-up for primary efficacy measurements and nonserious adverse
events and up to 40 months of follow-up for serious adverse events.InterventionsParticipants were randomized to 60 mg/d or 120 mg/d of raloxifene or
to identically appearing placebo pills; in addition, all women received supplemental
calcium and cholecalciferol.Main Outcome MeasuresIncident vertebral fracture was determined radiographically at baseline
and at scheduled 24- and 36-month visits. Nonvertebral fracture was ascertained
by interview at 6-month-interim visits. Bone mineral density was determined
annually by dual-energy x-ray absorptiometry.ResultsAt 36 months of the evaluable radiographs in 6828 women, 503 (7.4%)
had at least 1 new vertebral fracture, including 10.1% of women receiving
placebo, 6.6% of those receiving 60 mg/d of raloxifene, and 5.4% of those
receiving 120 mg/d of raloxifene. Risk of vertebral fracture was reduced in
both study groups receiving raloxifene (for 60-mg/d group: relative risk [RR],
0.7; 95% confidence interval [CI], 0.5-0.8; for 120-mg/d group: RR, 0.5; 95%
CI, 0.4-0.7). Frequency of vertebral fracture was reduced both in women who
did and did not have prevalent fracture. Risk of nonvertebral fracture for
raloxifene vs placebo did not differ significantly (RR, 0.9; 95% CI, 0.8-1.1
for both raloxifene groups combined). Compared with placebo, raloxifene increased
bone mineral density in the femoral neck by 2.1% (60 mg) and 2.4% (120 mg)
and in the spine by 2.6% (60 mg) and 2.7% (120 mg) P<0.001
for all comparisons). Women receiving raloxifene had increased risk of venous
thromboembolus vs placebo (RR, 3.1; 95% CI, 1.5-6.2). Raloxifene did not cause
vaginal bleeding or breast pain and was associated with a lower incidence
of breast cancer.ConclusionsIn postmenopausal women with osteoporosis, raloxifene increases bone
mineral density in the spine and femoral neck and reduces risk of vertebral
fracture.read more
Citations
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Journal ArticleDOI
Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.
Robert M. Neer,Claude D. Arnaud,Jose R. Zanchetta,Richard L. Prince,Gregory A Gaich,Jean-Yves Reginster,Anthony B. Hodsman,Erik Fink Eriksen,Sophia Ish-Shalom,Harry K. Genant,Ouhong Wang,Bruce H. Mitlak +11 more
TL;DR: Treatment of postmenopausal osteoporosis with parathyroid hormone decreases the risk of vertebral and nonvertebral fractures; increases vertebral, femoral, and total-body bone mineral density; and is well tolerated.
Journal ArticleDOI
Clinician’s Guide to Prevention and Treatment of Osteoporosis
Felicia Cosman,S. J. de Beur,Meryl S. LeBoff,E. M. Lewiecki,B. Tanner,S. Randall,Robert Lindsay +6 more
TL;DR: The Clinician’s Guide to Prevention and Treatment of Osteoporosis was developed by an expert committee of the National Osteiporosis Foundation in collaboration with a multispecialty council of medical experts in the field of bone health convened by NOF.
Journal ArticleDOI
Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis
Dennis M. Black,Pierre D. Delmas,Richard Eastell,Ian R. Reid,Steven Boonen,Jane A. Cauley,Felicia Cosman,Peter L. Lakatos,Ping Chung Leung,Z. Man,Carlos Mautalen,Peter Mesenbrink,Huilin Hu,John Caminis,Karen Tong,Theresa Rosario-Jansen,Joel S. Krasnow,Trisha F. Hue,Deborah E. Sellmeyer,Erik Fink Eriksen,Steven R. Cummings +20 more
TL;DR: Treatment with zoledronic acid reduced the risk of morphometric vertebral fracture by 70% during a 3-year period, as compared with placebo.
Journal ArticleDOI
Effects of Risedronate Treatment on Vertebral and Nonvertebral Fractures in Women With Postmenopausal Osteoporosis: A Randomized Controlled Trial
Steven T. Harris,Nelson B. Watts,Harry K. Genant,Clark D. McKeever,Thomas N. Hangartner,Michael Keller,Charles H. Chesnut,Jacques P. Brown,Erik Fink Eriksen,Mohammad S. Hoseyni,Douglas Wayne Axelrod,Paul D. Miller +11 more
TL;DR: Risedronate, a potent bisphosphonate, has been shown to be effective in the treatment of Paget disease of bone and other metabolic bone diseases, but, to the knowledge, it has not been evaluated in this article.
Journal ArticleDOI
European guidance for the diagnosis and management of osteoporosis in postmenopausal women
John A. Kanis,Eugene V. McCloskey,Helena Johansson,Cyrus Cooper,René Rizzoli,Jean-Yves Reginster +5 more
TL;DR: In this paper, the European Foundation for Osteoporosis and Bone disease (subsequently the International osteopo- rosis Foundation) published guidelines for the diagnosis and management of osteoporrosis in a European setting.
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