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Intermittent intravenous ibandronate injections have a similar
bone safety profile to daily oral dosing
Recker RR,1 Ste-Marie LG,2 Czerwinski E,3 Rowell L,4 Bonvoisin B,4 Masanauskaite D,4 Felsenberg D5
1Creighton University, Omaha, Nebraska, USA; 2CHUM Hôpital St-Luc, Montreal, Canada; 3Krakow Medical Centre, Krakow, Poland; 4F. Hoffmann-La Roche Ltd, Basel, Switzerland; 5Charité-University Medicine Berlin, Berlin, Germany ● Single transiliac bone biopsies were taken after 22 months (q3mo arms) or 23 months (q2mo arms) of oral or i.v.
● As expected, parameters of bone turnover were comparable treatment; prior to biopsy, double tetracycline labelling was ● In the Dosing IntraVenous Administration (DIVA) study, performed in the following schedule: 3 days of tetracycline 2mg every 2 months (q2mo) and 3mg every 3 months (label 1), 14 days without tetracycline, 3 days of – median Ac.F values were generally similar in all active (q3mo) intravenous (i.v.) ibandronate (Bonviva®) tetracycline (label 2); biopsies were performed 5–14 days treatment groups (Table 2), yet lower than reference
injections produced superior efficacy to 2.5mg daily values observed in untreated osteoporotic (0.42/year)6 oral ibandronate (for bone mineral density [BMD] and healthy (Table 2) postmenopausal women;
● All biopsy samples were analysed centrally (Creighton importantly, values were similar to the reference value osteoporosis; in an earlier study, this oral regimen had University Osteoporosis Research Center, Creighton seen in healthy premenopausal women (0.13/year)6 no adverse effects on the quality of newly formed – median values for MS/BS were broadly similar across the active treatment groups (Table 2), but were markedly
Analyses
● Qualitative histological and quantitative lower than the healthy postmenopausal reference value, histomorphometric analyses were performed in DIVA A qualitative histological analysis was performed to detect as anticipated (Table 2); again, results were not
after 22 or 23 months to assess the impact of the oral the presence of woven bone, marrow fibrosis, mineralisation markedly different to that seen in healthy premenopausal and i.v. regimens on the quality of newly formed bone and the bone remodelling process in a subset of ● Quantitative histomorphometric analyses included both static – as expected, median values for BFR/BV tended to be patients (n=89) who underwent single bone biopsy.
(e.g. osteoid thickness [O.Th], osteoid volume [OV/BV], lower than the healthy premenopausal reference value
(Table 2).
● In all patients, newly formed bone was of normal trabecular thickness [Tb.Th], trabecular number [Tb.N] and lamellar structure, without signs of woven bone, trabecular separation [Tb.Sp]) and dynamic (e.g. MAR, marrow fibrosis or cellular toxicity; no evidence of Ac.F, MS/BS and bone formation rate [BFR/BV]) ● Normal bone micro-architecture was observed in all osteomalacia, such as an excessive amount of osteoid or abnormal mineral apposition rate (MAR), was ● For between-group comparisons, median values and – median values for Tb.Th were comparable to the healthy 90% CIs were calculated for all quantitative parameters; postmenopausal reference value (Table 2)
● Values for activation frequency (Ac.f) and mineralising data were also compared with normal (reference) data from – compared with healthy postmenopausal reference values, surface (MS) were broadly similar in the i.v. and oral a patient population consisting of 34 healthy Tb.N was lower and Th.Sp higher in the active treatment treatment arms and lower than healthy postmenopausal postmenopausal women (aged 45–75 years, ≥1 YSM).5,6 groups, as anticipated (Table 2).
reference values; in both cases, values were notmarkedly different from those seen in healthypremenopausal women and an earlier study of daily Study population and patient
In conclusion, 2mg q2mo and 3mg q3mo i.v.
Table 2. Summary of key histomorphometric parameters (median,
90% CI) in DIVA plus normal reference values (healthy

ibandronate injections have similar bone safety profiles characteristics
postmenopausal women).
● A total of 109 participants underwent a single transiliac postmenopausal osteoporosis; no adverse effects on 2.5mg daily
Reference
bone mineralisation were detected and the rate of ● Qualitative histological analysis was performed on all (n=34)5,6
premenopausal levels. These findings are noteworthy, since the annual cumulative exposure (ACE) to ● Quantitative histomorphometric parameters were evaluable ibandronate provided by the i.v. regimens (12mg) is in 89 samples: 32 in the daily arm, 27 in the q2mo arm and 30 in the q3mo arm; static parameters were evaluable in all samples and dynamic parameters in 77 samples.
● Baseline characteristics of the participants providing evaluable samples were well balanced across the treatment arms (Table 1).
INTRODUCTION
● Histomorphometry is a powerful tool for evaluating the effects of therapeutics on bone quality and the bone remodelling process at the tissue level.
Table 1. Baseline patient characteristics of participants providing
Trabecular bone micro-architecture and structure evaluable samples (mean, SD).
In the oral iBandronate Osteoporosis vertebral fracture trial in North America and Europe (BONE) of daily (2.5mg) and intermittent (20mg every other day for 12 doses every 3 months; dosing interval >2 months) oral ibandronate, a nitrogen-containing bisphosphonate for postmenopausal (688.0, 792.0) (695.0, 861.0) (689.0, 771.0) osteoporosis, analyses of single bone biopsy samples taken at 3 years demonstrated that newly formed bone was of normal quality and structure; moreover, no adverse effects ● The subsequent DIVA study, a randomised, double-blind, double-dummy, phase III, non-inferiority study, demonstrated CONCLUSIONS
the superior efficacy of 2mg q2mo and 3mg q3mo i.v.
● In postmenopausal women with osteoporosis, 2mg ibandronate injections versus the 2.5mg daily oral q2mo and 3mg q3mo i.v. ibandronate injections ibandronate regimen; qualitative histological and (providing an ACE of 12mg) have a bone safety quantitative histomorphometric analyses were also profile that is generally comparable to the daily oral performed at 22 or 23 months to establish the bone safety regimen; no adverse effects on the quality of newly profile of the investigational regimens and provide further formed bone were detected and no impairment of insights into their impact on the bone remodelling process.3,4 ● The outcome of this analysis, which provides safety Qualitative histological analysis
● This finding is noteworthy, since the ACE to information on the highest ACE to ibandronate examined to ibandronate provided by the i.v. regimens is the ● In the i.v. and oral treatment groups, newly formed bone highest tested to date in osteoporotic women.
retained its lamellar structure, without signs of woven bone.
● No marrow fibrosis, signs of cellular toxicity or indicators of osteomalacia, such as excessive osteoid, were found.
Quantitative histomorphometric analysis
Bone biopsy study design and patient
REFERENCES
population
1. Chesnut CH, et al. J Bone Miner Res 2004;19:1241–49. ● In all treatment arms, no impairment of mineralisation of ● All participants were postmenopausal women (aged 2. Recker R, et al. Osteoporosis Int 2004;15:231–37.
newly formed bone was detected with active treatment 55–80 years, ≥5 years since menopause [YSM]) with 3. Delmas PD, et al. Arthritis Rheum 2006. In press.
osteoporosis (lumbar spine [L2–L4] BMD T-score <–2.5) who – median O.Th values were generally comparable across 4. Emkey R, et al. Arthritis Rheum 2005;52:4060 (Abstract 8).
received 2 years’ treatment with daily calcium (500mg) and the i.v. and oral treatment arms and lower than the 5. Recker R, et al. J Bone Miner Res 1988;3:133–44.
vitamin D (400IU), plus either 2mg q2mo i.v. ibandronate healthy postmenopausal reference value, as anticipated 6. Recker R, et al. J Bone Miner Res 2004;19:1628–33.
injections (plus daily oral placebo), 3mg q3mo i.v.
(Table 2); a similar outcome was observed for OV/BV
ibandronate injections (plus daily oral placebo) or 2.5mg (Table 2)
daily oral ibandronate (plus q2mo or q3mo i.v. placebo – median MAR values were comparable in all treatment injections); written informed consent was provided by all arms and also comparable to the healthy postmenopausal This research was supported by F. Hoffmann-La Roche Ltd and reference value, as expected (Table 2).

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