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Hayes Center, NY, United States

Roux C.,University of Paris Descartes | Goldstein J.L.,University of Illinois at Chicago | Zhou X.,Procter and Gamble | Klemes A.,Procter and Gamble | Lindsay R.,Helen Hayes Hospital
Osteoporosis International | Year: 2012

Summary Recent evidence suggests that proton pump inhibitor (PPI) use may affect fracture risk, an important issue for patients being concurrently treated for osteoporosis. The results of our post hoc analysis showed that, regardless of PPI concomitant use, risedronate significantly reduced the risk of new vertebral fractures compared with placebo. Introduction Recent evidence suggests that PPI use may affect fracture risk, an important issue for patients being concurrently treated for osteoporosis. Moreover, data suggest that concomitant use of PPIs may wane the antifracture effect of bisphosphonates. We explored the relationship between concomitant use of PPIs and incident vertebral fractures among patients treated with risedronate or placebo. Bone mineral density (BMD) and upper gastrointestinal (UGI) adverse events (AEs) were also assessed. Methods This study is a post hoc analysis of a subset of patients participating in three prospective, randomized, placebo-controlled clinical trials, with durations of up to 3 years, which evaluated the efficacy of risedronate in reducing fracture risk: Vertebral Efficacy with Risedronate Trial-MultiNational (VERT-MN); Vertebral Efficacy with Risedronate Trial-North America (VERT-NA); and the risedronate Hip Intervention Program (HIP). Results Total enrollment included 2,729 risedronate and 2,725 placebo patients. Concomitant acid-suppressing drugs were used by 8.8% of the total population (n=482). Regardless of PPI concomitant use, risedronate significantly reduced the risk of new vertebral fractures compared with placebo (risk reduction: PPI users 57%, p=0.009; PPI nonusers 38%, p<0.001). BMD increased with risedronate, independent of PPI use. PPI users were at a 2.5-fold greater risk of experiencing at least one UGI AE compared with non-users. Conclusions Risedronate significantly reduced the risk of new vertebral fractures compared with placebo, regardless of PPI concomitant use. © International Osteoporosis Foundation and National Osteoporosis Foundation 2011. Source


Toglia J.,Mercy College | Johnston M.V.,University of Wisconsin - Milwaukee | Goverover Y.,New York University | Dain B.,Helen Hayes Hospital
Brain Injury | Year: 2010

Background/aim: Persons with brain injury frequently demonstrate decreased ability to monitor and apply strategies learned in treatment to everyday situations. The aim of this study is to refine, explore and provide preliminary testing of the multicontext approach in promoting strategy use across situations and increasing self-regulation, awareness and functional performance. Methods: This study used a single-subject design with repeated measures pre- and post-intervention, with data analysed descriptively and graphically. Four persons with difficulty following multi-step directions, 35 years post-TBI, received a nine session intervention programme. Outcome measures included the Awareness Questionnaire, Self-Regulation Skills Interview, Behavior Rating Inventory of Executive Function, Multiple Errands Test and an Executive Function Performance Test sub-task. The process of change within each treatment session was examined with strategy and awareness ratings. Results: All participants demonstrated positive changes in self-regulatory skills and strategy use that was observed across tasks. As expected, general awareness of deficits remained unchanged. Examination of individual participants revealed important, varying patterns of change in strategy use, learning transfer and self-awareness across intervention. Conclusions: Results provide preliminary support for the feasibility and efficacy of the multicontext approach in promoting transfer of strategy use to enhance functional performance and selective aspects of awareness. Further investigation, including a larger controlled study, is needed to confirm or limit these observations. © 2010 Informa UK Ltd All rights reserved. Source


Cosman F.,Helen Hayes Hospital | Cosman F.,Columbia University | Keaveny T.M.,University of California at Berkeley | Kopperdahl D.,O.N. Diagnostics | And 4 more authors.
Journal of Bone and Mineral Research | Year: 2013

Many postmenopausal women treated with teriparatide for osteoporosis have previously received antiresorptive therapy. In women treated with alendronate (ALN) or raloxifene (RLX), adding versus switching to teriparatide produced different responses in areal bone mineral density (aBMD) and biochemistry; the effects of these approaches on volumetric BMD (vBMD) and bone strength are unknown. In this study, postmenopausal women with osteoporosis receiving ALN 70 mg/week (n = 91) or RLX 60 mg/day (n = 77) for ≥18 months were randomly assigned to add or switch to teriparatide 20 μg/day. Quantitative computed tomography scans were performed at baseline, 6 months, and 18 months to assess changes in vBMD; strength was estimated by nonlinear finite element analysis. A statistical plan specifying analyses was approved before assessments were completed. At the spine, median vBMD and strength increased from baseline in all groups (13.2% to 17.5%, p < 0.01); there were no significant differences between the Add and Switch groups. In the RLX stratum, hip vBMD and strength increased at 6 and 18 months in the Add group but only at 18 months in the Switch group (Strength, Month 18: 2.7% Add group, p < 0.01 and 3.4% Switch group, p < 0.05). In the ALN stratum, hip vBMD increased in the Add but not in the Switch group (0.9% versus -0.5% at 6 months and 2.2% versus 0.0% at 18 months, both p ≤ 0.004 group difference). At 18 months, hip strength increased in the Add group (2.7%, p < 0.01) but not in the Switch group (0%); however, the difference between groups was not significant (p = 0.076). Adding or switching to teriparatide conferred similar benefits on spine strength in postmenopausal women with osteoporosis pretreated with ALN or RLX. Increases in hip strength were more variable. In RLX-treated women, strength increased more quickly in the Add group; in ALN-treated women, a significant increase in strength compared with baseline was seen only in the Add group. Copyright © 2013 American Society for Bone and Mineral Research. Source


Black D.M.,University of California at San Francisco | Reid I.R.,University of Auckland | Cauley J.A.,University of Pittsburgh | Cosman F.,Helen Hayes Hospital | And 9 more authors.
Journal of Bone and Mineral Research | Year: 2015

While bisphosphonates reduce fracture risk over 3 to 5 years, the optimal duration of treatment is uncertain. In a randomized extension study (E1) of the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly-Pivotal Fracture Trial (HORIZON-PFT), zoledronic acid (ZOL) 5 mg annually for 6 years showed maintenance of bone mineral density (BMD), decrease in morphometric vertebral fractures, and a modest reduction in bone turnover markers (BTMs) compared with discontinuation after 3 years. To investigate the longer-term efficacy and safety of ZOL, a second extension (E2) was conducted to 9 years in which women on ZOL for 6 years in E1 were randomized to either ZOL (Z9) or placebo (Z6P3) for 3 additional years. In this multicenter, randomized, double-blind study, 190 women were randomized to Z9 (n = 95) and Z6P3 (n = 95). The primary endpoint was change in total hip BMD at year 9 vs. year 6 in Z9 compared with Z6P3. Other secondary endpoints included fractures, BTMs, and safety. From year 6 to 9, the mean change in total hip BMD was -0.54% in Z9 vs. -1.31% in Z6P3 (difference 0.78%; 95% confidence interval [CI]: -0.37%, 1.93%; p = 0.183). BTMs showed small, non-significant increases in those who discontinued after 6 years compared with those who continued for 9 years. The number of fractures was low and did not significantly differ by treatment. While generally safe, there was a small increase in cardiac arrhythmias (combined serious and non-serious) in the Z9 group but no significant imbalance in other safety parameters. The results suggest almost all patients who have received six annual ZOL infusions can stop medication for up to 3 years with apparent maintenance of benefits. © 2015 American Society for Bone and Mineral Research. © 2014 American Society for Bone and Mineral Research. Source


Pinkerton J.V.,University of Virginia | Harvey J.A.,University of Virginia | Lindsay R.,Helen Hayes Hospital | Pan K.,Pfizer | And 3 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2014

Objective: This phase 3 study evaluated the endometrial safety of bazedoxifene (BZA)/conjugated estrogens (CE) and bone mineral density (BMD) effects vs BZA alone, hormone therapy, and placebo (PBO). Methods: The Selective estrogens, Menopause, And Response to Therapy (SMART)-5 trial was a multicenter, randomized, double-blind, PBO- and active-controlled study in postmenopausal women with an intact uterus (N = 1843; aged 40-65 years) seeking treatment for menopausal symptoms. Subjects received daily oral BZA 20 mg/CE 0.45 or 0.625 mg, BZA 20 mg, CE 0.45 mg/ medroxyprogesterone acetate (MPA) 1.5 mg, or PBO. Primary endpoints were incidence of endometrial hyperplasia and percent change in lumbar spine BMD at 12 months. Secondary endpoints included additional osteoporosis parameters and assessments of tolerability and safety. Results: At 12 months, endometrial hyperplasia incidence was low (<1%) and similar among groups.TheBZA/CE groupshowedsignificantly greater increases in lumbar spineandtotal hipBMD vs decreases with PBO (P < .001); the CE/MPA group had increased lumbar spine BMD compared with that in the BZA/CE group. The BZA 20 mg/CE 0.45 and 0.625 mg groups had cumulative amenorrhea rates similar to those with PBO and BZA and significantly higher than those with CE 0.45 mg/MPA 1.5 mg (P<.001). The incidence of breast tenderness with BZA/CE was similar to that with PBO and BZA and significantly lower than with that with CE/MPA (P<.01). Although adverse event (AE) rates were similaramongthe groups, the incidence of serious AEs overall and AE-related discontinuation rates were higher with CE/MPA than with BZA/CE, BZA, or PBO. Conclusions: BZA/CE showed low rates of endometrial hyperplasia and improved lumbar spine and total hip BMD and was generally safe and well tolerated. Copyright © 2014 by the Endocrine Society. Source

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