April 2009

Tuesday, April 28, 2009

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VIBE Study Analysis

Study VIBE: First comparison head to head "on fracture risk in women treated with monthly oral ibandronate [Bonviva (R)] or weekly bisphosphonates

Wednesday April 30, 2009

VIBE Study: First compared head to head "on fracture risk in women treated with monthly oral ibandronate [Bonviva (R)] or weekly bisphosphonates

Urdinola Jaime MD

Andes Medical Association 9116 AK 20 CS 326 Bogotá DC Colombia

Phone 571/215 23 00 e-mail: jaimeurdinolamd@gmail.com

blogger: http://www.urdinola.blogspot.com/ www.urdinolamenopausia2.blogspot.com

Symposium / Luncheon on Women's Health and Medical MenopausiaAsociación

Andes

Board Room - Wednesday April 30, 2009

VIBE study a is important and topical, as it is the first to establish a comparison head to head "between the rates of monthly ibandronate fracture and weekly bisphosphonates administered orally. This is a large study of older women or 45aňos of age, who were given first monthly ibandronate or weekly bisphosphonates - alendronate or risedronate - orally, they did not display any type of malignancy or Paget's disease of bone.

The primary analysis included patients who had adherence to treatment during the first 90 days after the index date. The risk of hip fracture, no spinal cord and any clinical fracture were compared using risk models and adjusted Cox proportional to factors that could potentially lead to confusion.

A secondary analysis of "intention to treat including all patients who received at least one prescription of bisphosphonates.

sensitivity analysis based on the primary analysis compared patients who received ibandronate to patients who had received weekly alendronate or risedronate separately and explored the effect of excluding patients with factors that potentially could lead to confusion analysis. Further analysis of sensitivity varied the requirement of adherence during the first 90 days after the index date.

The primary analysis population included patients 7 345 56 837 monthly ibandronate with weekly bisphosphonate . Fracture rates after 12 months of observation period were < 2% y el riesgo de fractura no fué significativamente diferente entre pacientes que recibieron Ibandronato mensual o bisfosfonatos semanales, para fractura de cadera, fractura no vertebral o cualquier tipo de fractura clínica (riesgo relativo ajustado: cadera= 1.06, p=0.84; no vertebral=0.88, p=0.255; cualquier fractura clínica=0.82, p= 0.052).

But patients receiving ibandronate had a significantly lower risk of vertebral fracture than those who received weekly bisphosphonates (adjusted relative risk 0.36, confidence interval 95% 0.18 to 0.75, p = 0.006).

In the secondary analysis of "intent to treat" fractrura relative risks were not significantly different between treatment groups for any type of fracture. The results of sensitivity analysis were generally consistent with the primary analysis.

This retrospective cohort study found that patients treated with bisphosphonates ibandronate monthly or - alendronate, risedronate - weekly orally, had a similar and reduced risk of hip fracture, vertebral fracture and any fracture clinic.

But ibandronate patients had a significantly lower relative risk of vertebral fracture than patients who received weekly bisphosphonates. The clinical implications of these findings require further exploration and validation. In the beginning

bisphosphonates were marketed for daily administration and its efficacy in reducing vertebral and nonvertebral fractures was evaluated in clinical trials. The efficacy and regulatory approval of new dosage regimens (weekly monthly or quarterly), checking anti-fracture efficacy was established on the basis of changes in bone mineral density (BMD) compared to those seen with daily dosing.

But until now no study had been made "head to head" between bisphosphonates administered daily or the new extended dosing regimens. The monthly oral ibandronate 150 mg provides approx. twice the cumulative annual dose oral formulation of 2.5 mg daily. The effectiveness of this dose was examined in the study MOBILE 2, as well as in meta-analysis comparing monthly dose of 150 mg doses with quarterly 2 and 3 mg IV, which showed a significant reduction in nonvertebral fractures compared with placebo 3.

had not been studied head to head "comparison of the aforementioned anti-fracture efficacy, taking into account the large sample size needed to reliably detect differences in fracture risk and high costs associated. For this reason, databases used for analysis, which may allow sufficient sample sizes for the comparison of marketed doses in routine clinical practice. But as it is not randomized, it is possible that the study groups are different analysis of databases. To avoid the impact of these differences, is used to reduce the statistical adjustment, although the factors that potentially lead to confusion and biases may persist.

should also note the limitation that implies that this cohort study was based on data from patients seeking financial reimbursement for their medication, not research. Among other things, for example, there is no guarantee that the medication has been ingested properly or that the diagnosis of osteoporosis or fracture can not be wrong. But by chance, this could have occurred similarly in the 2 comparison groups. Neither fractures were evaluated so morphometrically. As non-randomized study may be significant differences between groups of patients, although this is not clinically important. Nor were adjusted p values \u200b\u200bfor multiple comparisons.

can conclude, therefore, that the observational analysis of the databases provide additional information to information obtained from randomized trials.

Summary of Important
● This study includes a fairly large sample, more diverse and the real world, that would allow a randomized trial with inclusion and exclusion criteria ●
stricter patient populations, treatment patterns and outcomes in routine clinical practice may differ from those we see in randomized trials. It is important and it is also necessary to assess outcomes in real world scenarios
● This study demonstrates, in real life, the risk of vertebral fracture in general or of hip fracture in particular women received up to one year of treatment with monthly ibandronate or bisphosphonates - alendronate, risedronate - orally, was similar
● But it also notes the study, vertebral fracture risk is lower in patients with adequate adhesion and receiving monthly ibandronate, compared with those receiving a weekly bisphosphonates
● Obviously, the clinical implications for the findings in reducing fractures need further exploration / research and validation of the data found

References
1 - Harris ST, et al. Risk of fracture in Women Treated with weekly or monthly oral bisphosphonates ibandronate: The Evaluation of Ibandronate Efficacy (VIBE) database fracture study. Bone. 2009, doi: 10.1016/j.bone.2009.01.002.
2 - Reginster JY, Adamis, Lakatos P, Greenwald M, Stepan JJ, Silverman SL, et al. Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study. Ann Rheum Dis. 2006, 65: 654-61.
3 - Harris ST, Blumentals WA, Miller PD. Ibandronate and the Risk of non-vertebral fractures in postmenopausal Women with osteoporosis: results of a meta-analysis of phase III studies. Curr Med Res Opin 2008, 24: 237-45.

If you have any comments, questions or concerns, you can "click" on comments and sending your message. Or if you prefer, you can send your comments, questions or concerns e-mail jaimeurdinolamd@gmail.com

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Wednesday, February 25, 200 9

Risedronate or Alendronate affects treatment with Teriparatide?

Urdinola Jaime MD
CS AK 9 116-20 326 - Medical Association of the Andes - Bogotá DC Colombia

Phone: 571 / 215 23 00 - Phone: 57 / 315 236 e August 28

Email: jaimeurdinolamd@gmail.com
blogger: http://www.urdinola.blogspot.com

http://www.urdinolamenopausia.blogspot.com

http:/ / www.urdinolamenopausia2.blogspot.com

Symposium / Luncheon on Menopause - Wednesday, February 25, 2009 1st Floor Boardroom Medical Association Andes - AK 9 116-20 Bogotá DC Colombia

Introduction has been shown that teriparatide, human PTH (1-34), reduces the risk of new vertebral and nonvertebral fractures in postmenopausal women with osteoporosis 1.

As the use of teriparatide is recommended only for 18 to 24 months, patients with large and early response are those that present the optimum benefit of the anabolic agent. Also is known that pretreatment with antiresorptive as estrogen and raloxifene allows teriparatide rapidly increase bone turnover markers and bone mineral density (BMD), whereas treatment with alendronate before administration of teriparatide or in combination with this can disrupt or delay the response 2. This could be explained, considering that alendronate remains as reported, for longer in the bone due to its greater affinity for hydroxyapatite.

combined or sequential studies with bisphosphonates and teriparatide are used almost exclusively alendronate. Therefore, until not yet known whether other bisphosphonates can disrupt or delay the anabolic response to teriparatide, an effect that may be related to the extent to which the bisphosphonate reduces bone turnover and maintains this reduction after stopping the drug.

Based on the pharmacological differences between alendronate and risedronate, the authors of the study that analyzes today postulate the hypothesis that risedronate might not affect the after-effects of teriparatide in the same magnitude as previous treatment with alendronate. This study in 324 postmenopausal women with osteoporosis is clinically relevant, as many patients receiving teriparatide have been treated con uno de estos dos bisfosfonatos.

Métodos
Pacientes que habían sido tratadas previamente con alendronato o Risedronato durante por lo menos 24 meses, descontinuaron el bisfosfonato y recibieron teriparatida durante 12 meses. En un estudio multinacional y de grupos paralelos, de acuerdo con las guías de buenas prácticas clínicas, la Declaración de Helsinki y las normas de diferentes países que participaron en el estudio 3 .

Patrocinadores
El estudio fue diseñado por el Comité Directivo de los Investigadores y la Alianza para la Mejor Salud Ósea (Procter&Gamble Pharmaceuticals y Sanofi-aventis).

Researchers in each country collected the data, the Sanofi-aventis statistical data analyzed according to an agreed plan and pre-specified by the sponsors. All authors had full access to the raw data, wrote the manuscript and are responsible for the accuracy and complete publication.

also was conducted independent statistical review at Helen Hayes Hospital in New York, under the guidance of the Steering Committee Investigators. The findings of this independent statistical review agreed with those of the original statistical analysis.

Study Population We included postmenopausal women with osteoporosis who received alendronate or risedronate for at least 24 months (lumbar spine or total hip, index < 2.0
T (<> 1, levels of 25-OH-vitamin D
> 16 and < 80 ng/ml, telopéptido urinario (NTX) < 50 equivalentes de colágeno óseo nmol/mmol de creatinina, para asegurar la adherencia a la terapia previa con bisfosfonatos.

Excluded those with decreased renal function, treatment with other antiresorptive different risedronate or alendronate, hormone therapy with sex steroids in the previous 36 months, systemic corticosteroids or anabolic in the previous 3 months for 1 month or for longer than in the previous 6 months, calcitonin, calcifediol calcitriol or the month before or during a longer period in the previous 6 months, a combination of risedronate and alendronate previous 60 months, or any antiresorptive agent in combination with risedronate or alendronate.

Study Protocol After the recruitment of patients discontinued their bisphosphonate and started daily teriparatide (20 mcg SC) for 12 months, controlled 11 times. Because the study was open and nonrandomized, were pooled and stratified according to the bisphosphonate received. Outcomes

The primary endpoint of analysis was to compare the mean absolute change from baseline of the N-teminal peptide (P1NP) after 3 months of treatment with teriparatide, among subjects who had previously received Risedronate and alendronate. This time of 3 months was selected by previous reports of associations between early changes in bone turnover markers with BMD improved to 12-18 and 24 months.

analysis The secondary endpoints included comparisons with the baseline of the average changes and relationship to P1NP (N-terminal propeptide of collagen type 1), the activity of bone-specific alkaline phosphatase (BAP), osteocalcin (OC ), serum C-telopeptide (CTX) and the ratio of N-telopeptide with urinary creatinine (NTX) at 0.5, 1-6 and 12 months.

also included comparisons of average and percentage changes in area de la DMO por DXA a los 6 y 12 meses, así como la DMO volumétrica por tomografía computadorizada en forma basal y a los 12 meses.

Se investigaron las correlaciones de los cambios tempranos en los marcadores óseos con los cambios en la DMO a los 12 meses.

Resultados
En el grupo que previamente había recibido Risedronato, el aumento de P1NP fue significativamente mayor después de 3 meses de tratamiento con teriparatida que en el grupo que había recibido alendronato ( promedio + SE [Error estándar] 86.0 + 5.6 vs. 61.2 + 5.3 ng/mL, respectivamente; P < 0.001).

Los hallazgos fueron similares para los otros marcadores de recambio óseo.
Los cambios en el BMD area and volumetric analysis of the trabeculae of the vertebrae were higher in the group who had previously received risedronate (P <0.05).

Early changes in bone turnover markers were correlated with BMD changes in the volumetric analysis the trabeculae of the vertebrae at 12 months (Spearman r = 0.45), finding that after treatment with risedronate, changes at 12 months were almost twice that observed in the alendronate group.

treatment Teriparatide was well tolerated in both groups. The most frequently reported adverse effects were hypercalcemia, muscle spasms, nausea, dizziness and arthralgia.
Conclusions

This nonrandomized but prospective study suggests that there may be differences in anabolic response to teriparatide as a function of prior exposure to the type of bisphosphonate. The patients previously treated with risedronate showed a greater response with early and pronounced increase in levels of P1NP level and volumetric BMD, than those previously treated with alendronate. This requires further investigation to fully understand the potential clinical impact.

The study was designed using teriparatide for 12 months. Was not powerful enough to measure the incidence of fractures and should be considered in this context.

References
1 - Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med 2001, 344: 1434-1441.
2 - Black DM, Greenspan SL, Ensrud Ker, Palermo L, McGowan JA, Lang TF, Garnero P, Bouxsein ML, Bilezikian JPO, Rosen CJ, PATH Study Investigator. The effect of parathyroid hormone and alendronate Alone or in combination in postmenopausal osteoporosis. N Engl J Med 2003; 349: 1207 – 1215.
3- Miller PD, Delmas PD, Lindsay R, Watts NB, Luckey M, Adachi J, Saag K, Greenspan L, Seeman E, Boonen S, Meeves S, Lang TF, Bilezikian J, for the Open-label Study to Determine How Prior Therapy with Alendronate or Risedronate in Postmenopausal Women with Osteoporosis Influences the Clinical Efectiveness of Teriparatide Investigators. Early Responsiveness of Women with Osteoporosis to Teriparatide After Therapy with Alendronate or Risedronate. J. Clin Endocrinol Metab 2 008; 93: 3785-3793.