Tocilizumab Effective Regardless of Prior Therapy

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KANANASKIS, ALTA. — The finding that the monoclonal antibody tocilizumab provided rapid and sustained improvement in the signs and symptoms of rheumatoid arthritis, regardless of patients' prior therapy, is not compelling enough to abandon methotrexate.

Dr. Robert McKendry said he was not convinced that he would turn to tocilizumab before methotrexate in rheumatoid arthritis patients.

“The difference between tocilizumab's efficacy and methotrexate's is real, but not necessarily dramatic,” according to Dr. McKendry, professor of medicine at the University of Ottawa.

“Moreover, most of these products—tocilizumab and others—work about 30% better when given with a background of methotrexate.

“So I think we're going to continue to do that until there's a reason not to,” Dr. McKendry said at the annual meeting of the Canadian Rheumatology Association.

Dr. McKendry made these remarks while presenting an analysis of data from more than 3,000 patients who used tocilizumab as monotherapy or in combination with disease modifying antirheumatic drugs (DMARDs) or methotrexate. The patients participated in any one of four phase III trials: TOWARD (Tocilizumab in Combination With Traditional DMARD Therapy), OPTION (Tocilizumab Pivotal Trial in Methotrexate Inadequate Responders), RADIATE (Research on Actemra [tocilizumab] Determining Efficacy After Anti-TNF [tumor necrosis factor] Failures), and AMBITION (Actemra Versus Methotrexate Double-Blind Investigative Trial in Monotherapy), he said.

“This product has a unique mechanism of action in that it blocks the [interleukin-6] receptor, which is very important in many aspects of inflammation,” he said.

Each of the trials was randomized and double-blinded, and consisted of a 24-week study period in patients with moderate to severe active rheumatoid arthritis; each patient received a standardized tocilizumab IV dose of 8 mg/kg.

In TOWARD, patients with inadequate prior response to DMARDs received tocilizumab or placebo in combination with DMARDs. OPTION included methotrexate patients who received tocilizumab or placebo plus 10–25 mg/wk methotrexate.

In RADIATE, patients with moderate to severe RA who had an inadequate response to at least one anti-TNF agent received either tocilizumab or placebo plus 10–25 mg/wk methotrexate.

Finally, AMBITION assessed the effects of tocilizumab monotherapy every 4 weeks or methotrexate monotherapy (escalating dosage, 7.5–20 mg/wk) in patients who had not failed previous methotrexate or biologic treatment.

It was found that in all four studies, differences between the tocilizumab and control groups became apparent by the first scheduled assessment at week 2, regardless of prior therapy.

“I emphasize that [tocilizumab] works quickly, compared with other biologics,” Dr. McKendry said in an interview. “You get a significant response within the first 2 weeks, the first time you see the patient.” The studies showed that 17%–25% of patients on tocilizumab achieved an ACR 20 response in the first 2 weeks, compared with 7%–10% of controls.

ACR 50 and ACR 70 responses were observed in a greater percentage of tocilizumab patients than controls from weeks 4 and 8 onward. Patients treated with tocilizumab also demonstrated greater DAS28 improvements from baseline than did controls; DAS28 remission rates were also greater in tocilizumab patients by week 2.

Dr. McKendry had no disclosures to report.

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KANANASKIS, ALTA. — The finding that the monoclonal antibody tocilizumab provided rapid and sustained improvement in the signs and symptoms of rheumatoid arthritis, regardless of patients' prior therapy, is not compelling enough to abandon methotrexate.

Dr. Robert McKendry said he was not convinced that he would turn to tocilizumab before methotrexate in rheumatoid arthritis patients.

“The difference between tocilizumab's efficacy and methotrexate's is real, but not necessarily dramatic,” according to Dr. McKendry, professor of medicine at the University of Ottawa.

“Moreover, most of these products—tocilizumab and others—work about 30% better when given with a background of methotrexate.

“So I think we're going to continue to do that until there's a reason not to,” Dr. McKendry said at the annual meeting of the Canadian Rheumatology Association.

Dr. McKendry made these remarks while presenting an analysis of data from more than 3,000 patients who used tocilizumab as monotherapy or in combination with disease modifying antirheumatic drugs (DMARDs) or methotrexate. The patients participated in any one of four phase III trials: TOWARD (Tocilizumab in Combination With Traditional DMARD Therapy), OPTION (Tocilizumab Pivotal Trial in Methotrexate Inadequate Responders), RADIATE (Research on Actemra [tocilizumab] Determining Efficacy After Anti-TNF [tumor necrosis factor] Failures), and AMBITION (Actemra Versus Methotrexate Double-Blind Investigative Trial in Monotherapy), he said.

“This product has a unique mechanism of action in that it blocks the [interleukin-6] receptor, which is very important in many aspects of inflammation,” he said.

Each of the trials was randomized and double-blinded, and consisted of a 24-week study period in patients with moderate to severe active rheumatoid arthritis; each patient received a standardized tocilizumab IV dose of 8 mg/kg.

In TOWARD, patients with inadequate prior response to DMARDs received tocilizumab or placebo in combination with DMARDs. OPTION included methotrexate patients who received tocilizumab or placebo plus 10–25 mg/wk methotrexate.

In RADIATE, patients with moderate to severe RA who had an inadequate response to at least one anti-TNF agent received either tocilizumab or placebo plus 10–25 mg/wk methotrexate.

Finally, AMBITION assessed the effects of tocilizumab monotherapy every 4 weeks or methotrexate monotherapy (escalating dosage, 7.5–20 mg/wk) in patients who had not failed previous methotrexate or biologic treatment.

It was found that in all four studies, differences between the tocilizumab and control groups became apparent by the first scheduled assessment at week 2, regardless of prior therapy.

“I emphasize that [tocilizumab] works quickly, compared with other biologics,” Dr. McKendry said in an interview. “You get a significant response within the first 2 weeks, the first time you see the patient.” The studies showed that 17%–25% of patients on tocilizumab achieved an ACR 20 response in the first 2 weeks, compared with 7%–10% of controls.

ACR 50 and ACR 70 responses were observed in a greater percentage of tocilizumab patients than controls from weeks 4 and 8 onward. Patients treated with tocilizumab also demonstrated greater DAS28 improvements from baseline than did controls; DAS28 remission rates were also greater in tocilizumab patients by week 2.

Dr. McKendry had no disclosures to report.

KANANASKIS, ALTA. — The finding that the monoclonal antibody tocilizumab provided rapid and sustained improvement in the signs and symptoms of rheumatoid arthritis, regardless of patients' prior therapy, is not compelling enough to abandon methotrexate.

Dr. Robert McKendry said he was not convinced that he would turn to tocilizumab before methotrexate in rheumatoid arthritis patients.

“The difference between tocilizumab's efficacy and methotrexate's is real, but not necessarily dramatic,” according to Dr. McKendry, professor of medicine at the University of Ottawa.

“Moreover, most of these products—tocilizumab and others—work about 30% better when given with a background of methotrexate.

“So I think we're going to continue to do that until there's a reason not to,” Dr. McKendry said at the annual meeting of the Canadian Rheumatology Association.

Dr. McKendry made these remarks while presenting an analysis of data from more than 3,000 patients who used tocilizumab as monotherapy or in combination with disease modifying antirheumatic drugs (DMARDs) or methotrexate. The patients participated in any one of four phase III trials: TOWARD (Tocilizumab in Combination With Traditional DMARD Therapy), OPTION (Tocilizumab Pivotal Trial in Methotrexate Inadequate Responders), RADIATE (Research on Actemra [tocilizumab] Determining Efficacy After Anti-TNF [tumor necrosis factor] Failures), and AMBITION (Actemra Versus Methotrexate Double-Blind Investigative Trial in Monotherapy), he said.

“This product has a unique mechanism of action in that it blocks the [interleukin-6] receptor, which is very important in many aspects of inflammation,” he said.

Each of the trials was randomized and double-blinded, and consisted of a 24-week study period in patients with moderate to severe active rheumatoid arthritis; each patient received a standardized tocilizumab IV dose of 8 mg/kg.

In TOWARD, patients with inadequate prior response to DMARDs received tocilizumab or placebo in combination with DMARDs. OPTION included methotrexate patients who received tocilizumab or placebo plus 10–25 mg/wk methotrexate.

In RADIATE, patients with moderate to severe RA who had an inadequate response to at least one anti-TNF agent received either tocilizumab or placebo plus 10–25 mg/wk methotrexate.

Finally, AMBITION assessed the effects of tocilizumab monotherapy every 4 weeks or methotrexate monotherapy (escalating dosage, 7.5–20 mg/wk) in patients who had not failed previous methotrexate or biologic treatment.

It was found that in all four studies, differences between the tocilizumab and control groups became apparent by the first scheduled assessment at week 2, regardless of prior therapy.

“I emphasize that [tocilizumab] works quickly, compared with other biologics,” Dr. McKendry said in an interview. “You get a significant response within the first 2 weeks, the first time you see the patient.” The studies showed that 17%–25% of patients on tocilizumab achieved an ACR 20 response in the first 2 weeks, compared with 7%–10% of controls.

ACR 50 and ACR 70 responses were observed in a greater percentage of tocilizumab patients than controls from weeks 4 and 8 onward. Patients treated with tocilizumab also demonstrated greater DAS28 improvements from baseline than did controls; DAS28 remission rates were also greater in tocilizumab patients by week 2.

Dr. McKendry had no disclosures to report.

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Physician Extenders Needed to Help Fill Gap in Arthritis Care

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KANANASKIS, ALTA. — Rheumatologists' best hope for dealing with the coming deluge of joint disease is to use physician extenders to triage patients and oversee their physical therapy.

A report by the American College of Rheumatology has anticipated a significant shortage of rheumatologists that will begin after 2010 and continue for at least 20 years. In 2006, when the report was published, fellows of the ACR averaged 56 years of age. Rheumatology is one of many specialties with projected shortfalls of physicians that may reach 200,000 by 2025, according to the ACR (Arthritis Rheum. 2007;56:722–9).

“The challenge is in determining who is going to do what. Fortunately, we now have some evidence to show that doing things differently can help facilitate the delivery of these interventions to more people in a more timely manner,” Linda Li, Ph.D., said at the annual meeting of the Canadian Rheumatology Association.

Dr. Li and her associates developed an integrated framework for rheumatoid arthritis treatment to shorten the delays between various levels of care, based on a review of the literature (Arthritis Rheum. 2008;59:1171–83).

The framework begins at the community level, where health care services should provide information to patients during the interval between symptom onset and the first visit to a primary care physician. “Some interventions involve using community therapists, pharmacists, and nurses to facilitate the transition from community to primary care,” noted Dr. Li, the Harold Robinson/Arthritis Society Chair in Arthritic Diseases at the University of British Columbia, Vancouver.

One study looked at the use of community pharmacists to disseminate information about the relationship between knee pain and osteoarthritis (Arthritis Rheum. 2007;57:1238–44). A simple screening questionnaire found that 190 (98%) of 194 patients who indicated knee pain met ACR clinical criteria for knee osteoarthritis.

At the primary care level, where specially trained nurses triaged rheumatology referrals using standardized guidelines, the rate of appropriate referrals increased from 50% to 90% within 2 years (Rheumatology [Oxford] 2003;42:763–8).

Another study found that specially trained physical therapists reduced referrals to orthopedists by 17% and to rheumatologists by 8%, compared with the conventional model of direct referral from general practitioners to hospital departments (Am. J. Phys. Med. Rehabil. 2005;84:702–11).

Secondary care focuses on self-management and follow-up assessments, yet another area where nonphysicians can play a role in effective clinical care, Dr. Li said. This frees up rheumatologists to see the sickest people, she added.

Dr. Linda Li is supported by the Harold Robinson/Arthritis Society Chair in Arthritic Diseases, a Canadian Institutes of Health Research (CIHR) New Investigator Award, and an American College of Rheumatology Research & Education Foundation Health Professional New Investigator Award.

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KANANASKIS, ALTA. — Rheumatologists' best hope for dealing with the coming deluge of joint disease is to use physician extenders to triage patients and oversee their physical therapy.

A report by the American College of Rheumatology has anticipated a significant shortage of rheumatologists that will begin after 2010 and continue for at least 20 years. In 2006, when the report was published, fellows of the ACR averaged 56 years of age. Rheumatology is one of many specialties with projected shortfalls of physicians that may reach 200,000 by 2025, according to the ACR (Arthritis Rheum. 2007;56:722–9).

“The challenge is in determining who is going to do what. Fortunately, we now have some evidence to show that doing things differently can help facilitate the delivery of these interventions to more people in a more timely manner,” Linda Li, Ph.D., said at the annual meeting of the Canadian Rheumatology Association.

Dr. Li and her associates developed an integrated framework for rheumatoid arthritis treatment to shorten the delays between various levels of care, based on a review of the literature (Arthritis Rheum. 2008;59:1171–83).

The framework begins at the community level, where health care services should provide information to patients during the interval between symptom onset and the first visit to a primary care physician. “Some interventions involve using community therapists, pharmacists, and nurses to facilitate the transition from community to primary care,” noted Dr. Li, the Harold Robinson/Arthritis Society Chair in Arthritic Diseases at the University of British Columbia, Vancouver.

One study looked at the use of community pharmacists to disseminate information about the relationship between knee pain and osteoarthritis (Arthritis Rheum. 2007;57:1238–44). A simple screening questionnaire found that 190 (98%) of 194 patients who indicated knee pain met ACR clinical criteria for knee osteoarthritis.

At the primary care level, where specially trained nurses triaged rheumatology referrals using standardized guidelines, the rate of appropriate referrals increased from 50% to 90% within 2 years (Rheumatology [Oxford] 2003;42:763–8).

Another study found that specially trained physical therapists reduced referrals to orthopedists by 17% and to rheumatologists by 8%, compared with the conventional model of direct referral from general practitioners to hospital departments (Am. J. Phys. Med. Rehabil. 2005;84:702–11).

Secondary care focuses on self-management and follow-up assessments, yet another area where nonphysicians can play a role in effective clinical care, Dr. Li said. This frees up rheumatologists to see the sickest people, she added.

Dr. Linda Li is supported by the Harold Robinson/Arthritis Society Chair in Arthritic Diseases, a Canadian Institutes of Health Research (CIHR) New Investigator Award, and an American College of Rheumatology Research & Education Foundation Health Professional New Investigator Award.

KANANASKIS, ALTA. — Rheumatologists' best hope for dealing with the coming deluge of joint disease is to use physician extenders to triage patients and oversee their physical therapy.

A report by the American College of Rheumatology has anticipated a significant shortage of rheumatologists that will begin after 2010 and continue for at least 20 years. In 2006, when the report was published, fellows of the ACR averaged 56 years of age. Rheumatology is one of many specialties with projected shortfalls of physicians that may reach 200,000 by 2025, according to the ACR (Arthritis Rheum. 2007;56:722–9).

“The challenge is in determining who is going to do what. Fortunately, we now have some evidence to show that doing things differently can help facilitate the delivery of these interventions to more people in a more timely manner,” Linda Li, Ph.D., said at the annual meeting of the Canadian Rheumatology Association.

Dr. Li and her associates developed an integrated framework for rheumatoid arthritis treatment to shorten the delays between various levels of care, based on a review of the literature (Arthritis Rheum. 2008;59:1171–83).

The framework begins at the community level, where health care services should provide information to patients during the interval between symptom onset and the first visit to a primary care physician. “Some interventions involve using community therapists, pharmacists, and nurses to facilitate the transition from community to primary care,” noted Dr. Li, the Harold Robinson/Arthritis Society Chair in Arthritic Diseases at the University of British Columbia, Vancouver.

One study looked at the use of community pharmacists to disseminate information about the relationship between knee pain and osteoarthritis (Arthritis Rheum. 2007;57:1238–44). A simple screening questionnaire found that 190 (98%) of 194 patients who indicated knee pain met ACR clinical criteria for knee osteoarthritis.

At the primary care level, where specially trained nurses triaged rheumatology referrals using standardized guidelines, the rate of appropriate referrals increased from 50% to 90% within 2 years (Rheumatology [Oxford] 2003;42:763–8).

Another study found that specially trained physical therapists reduced referrals to orthopedists by 17% and to rheumatologists by 8%, compared with the conventional model of direct referral from general practitioners to hospital departments (Am. J. Phys. Med. Rehabil. 2005;84:702–11).

Secondary care focuses on self-management and follow-up assessments, yet another area where nonphysicians can play a role in effective clinical care, Dr. Li said. This frees up rheumatologists to see the sickest people, she added.

Dr. Linda Li is supported by the Harold Robinson/Arthritis Society Chair in Arthritic Diseases, a Canadian Institutes of Health Research (CIHR) New Investigator Award, and an American College of Rheumatology Research & Education Foundation Health Professional New Investigator Award.

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Software Simplifies Fracture Risk Prediction

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KANANASKIS, ALTA. — An investigational computer program considers more than just bone mineral density in determining fracture risk, summarizing its findings in a color-coded representation of the patient.

Developed by rheumatologist William Bensen, the Bone DESTINY software program predicts fractures more reliably than do bone mineral density (BMD) assessments alone. Using the Bone DESTINY program achieves prediction accuracy comparable with that attained by following the guidelines developed by Osteoporosis Canada (Can. Assoc. Radiol. J. 2005;56:178–88).

Bone DESTINY software is free to physicians but has not been released for general use yet. Its development has been funded by Dr. Bensen and McMaster University, Hamilton, Ont.

Bone DESTINY begins with bone density, then factors in age, steroid use, propensity to fall, history of previous falls, body mass index, and previous fragility fractures, said Dr. Maggie Larché, a rheumatologist at McMaster.

“These data are plugged into a handheld computer, which then generates a graphic with a color-coded representation of the patient's risk.” The program produces an accompanying text report.

In the first of two studies presented at the annual meeting of the Canadian Rheumatology Association, Dr. Larché and her colleagues at McMaster studied the predictive value of the software program in 14,812 postmenopausal women at least 60 years old. For each patient, treatment recommendations were produced based on BMD alone, Osteoporosis Canada guidelines, or Bone DESTINY results.

Among 7,049 patients aged 60–69 years, BMD analysis alone recommended treatment in 19%. By comparison, 20% were recommended for treatment according to OC guidelines, and 28% according to the software. In 5,252 patients aged 70–79 years, 29% were recommended for treatment based on BMD alone, 43% according to Bone DESTINY, and 51% according to OC guidelines. In 2,511 patients at least 80 years old, 47%, 72%, and 77% would be recommended for treatment according to BMD, OC guidelines, and Bone DESTINY results, respectively.

A second study compared predictive values of the three methods in 572 men and 3,914 women (aged 50 years and older) who had suffered at least one previous fragility fracture.

For all age groups, both Bone DESTINY and OC guidelines recommended treatment in 80% of the women to prevent another fracture; 35% of the women would have received treatment based on BMD alone, Dr. Larché reported.

The most significant difference, however, was observed in men, in whom Bone DESTINY recommended treatment in 73%, compared with 26% by BMD alone and 41% by OC guidelines.

Dr. Larché reported receiving honoraria and/or speakers fees from Amgen, Abbott, BMS, Pfizer, Schering, and GSK.

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KANANASKIS, ALTA. — An investigational computer program considers more than just bone mineral density in determining fracture risk, summarizing its findings in a color-coded representation of the patient.

Developed by rheumatologist William Bensen, the Bone DESTINY software program predicts fractures more reliably than do bone mineral density (BMD) assessments alone. Using the Bone DESTINY program achieves prediction accuracy comparable with that attained by following the guidelines developed by Osteoporosis Canada (Can. Assoc. Radiol. J. 2005;56:178–88).

Bone DESTINY software is free to physicians but has not been released for general use yet. Its development has been funded by Dr. Bensen and McMaster University, Hamilton, Ont.

Bone DESTINY begins with bone density, then factors in age, steroid use, propensity to fall, history of previous falls, body mass index, and previous fragility fractures, said Dr. Maggie Larché, a rheumatologist at McMaster.

“These data are plugged into a handheld computer, which then generates a graphic with a color-coded representation of the patient's risk.” The program produces an accompanying text report.

In the first of two studies presented at the annual meeting of the Canadian Rheumatology Association, Dr. Larché and her colleagues at McMaster studied the predictive value of the software program in 14,812 postmenopausal women at least 60 years old. For each patient, treatment recommendations were produced based on BMD alone, Osteoporosis Canada guidelines, or Bone DESTINY results.

Among 7,049 patients aged 60–69 years, BMD analysis alone recommended treatment in 19%. By comparison, 20% were recommended for treatment according to OC guidelines, and 28% according to the software. In 5,252 patients aged 70–79 years, 29% were recommended for treatment based on BMD alone, 43% according to Bone DESTINY, and 51% according to OC guidelines. In 2,511 patients at least 80 years old, 47%, 72%, and 77% would be recommended for treatment according to BMD, OC guidelines, and Bone DESTINY results, respectively.

A second study compared predictive values of the three methods in 572 men and 3,914 women (aged 50 years and older) who had suffered at least one previous fragility fracture.

For all age groups, both Bone DESTINY and OC guidelines recommended treatment in 80% of the women to prevent another fracture; 35% of the women would have received treatment based on BMD alone, Dr. Larché reported.

The most significant difference, however, was observed in men, in whom Bone DESTINY recommended treatment in 73%, compared with 26% by BMD alone and 41% by OC guidelines.

Dr. Larché reported receiving honoraria and/or speakers fees from Amgen, Abbott, BMS, Pfizer, Schering, and GSK.

KANANASKIS, ALTA. — An investigational computer program considers more than just bone mineral density in determining fracture risk, summarizing its findings in a color-coded representation of the patient.

Developed by rheumatologist William Bensen, the Bone DESTINY software program predicts fractures more reliably than do bone mineral density (BMD) assessments alone. Using the Bone DESTINY program achieves prediction accuracy comparable with that attained by following the guidelines developed by Osteoporosis Canada (Can. Assoc. Radiol. J. 2005;56:178–88).

Bone DESTINY software is free to physicians but has not been released for general use yet. Its development has been funded by Dr. Bensen and McMaster University, Hamilton, Ont.

Bone DESTINY begins with bone density, then factors in age, steroid use, propensity to fall, history of previous falls, body mass index, and previous fragility fractures, said Dr. Maggie Larché, a rheumatologist at McMaster.

“These data are plugged into a handheld computer, which then generates a graphic with a color-coded representation of the patient's risk.” The program produces an accompanying text report.

In the first of two studies presented at the annual meeting of the Canadian Rheumatology Association, Dr. Larché and her colleagues at McMaster studied the predictive value of the software program in 14,812 postmenopausal women at least 60 years old. For each patient, treatment recommendations were produced based on BMD alone, Osteoporosis Canada guidelines, or Bone DESTINY results.

Among 7,049 patients aged 60–69 years, BMD analysis alone recommended treatment in 19%. By comparison, 20% were recommended for treatment according to OC guidelines, and 28% according to the software. In 5,252 patients aged 70–79 years, 29% were recommended for treatment based on BMD alone, 43% according to Bone DESTINY, and 51% according to OC guidelines. In 2,511 patients at least 80 years old, 47%, 72%, and 77% would be recommended for treatment according to BMD, OC guidelines, and Bone DESTINY results, respectively.

A second study compared predictive values of the three methods in 572 men and 3,914 women (aged 50 years and older) who had suffered at least one previous fragility fracture.

For all age groups, both Bone DESTINY and OC guidelines recommended treatment in 80% of the women to prevent another fracture; 35% of the women would have received treatment based on BMD alone, Dr. Larché reported.

The most significant difference, however, was observed in men, in whom Bone DESTINY recommended treatment in 73%, compared with 26% by BMD alone and 41% by OC guidelines.

Dr. Larché reported receiving honoraria and/or speakers fees from Amgen, Abbott, BMS, Pfizer, Schering, and GSK.

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