The Lancet~Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial

   

     

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The Lancet, Early Online Publication, 15 May 2013

doi:10.1016/S0140-6736(13)60856-9Cite or Link Using DOI

This article can be found in the following collection:

Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial

Original Text

Joy N Tsai MD a †, Alexander V Uihlein MD a †, Hang Lee PhD b, Ruchit Kumbhani BA a, Erica Siwila-Sackman BA a, Elizabeth A McKay BA a, Sherri-Ann M Burnett-Bowie MD a, Robert M Neer MD a, Dr Benjamin Z Leder MD a

Summary

Background

Osteoporosis medications increase bone-mineral density (BMD) and lower but do not eliminate fracture risk. The combining of anabolic agents with bisphosphonates has not improved efficacy. We compared combined teriparatide and denosumab with both agents alone.

Methods

From September, 2009, to January, 2011, we enrolled postmenopausal women with osteoporosis into this randomised, controlled trial. Patients were assigned in a 1:1:1 ratio to receive 20 μg teriparatide daily, 60 mg denosumab every 6 months, or both. BMD was measured at 0, 3, 6, and 12 months. Women who completed at least one study visit after baseline were assessed in a modified intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00926380.

Findings

94 (94%) of 100 eligible women completed at least one study visit after baseline. At 12 months, posterior-anterior lumbar spine BMD increased more in the combination group (9·1%, [SD 3·9]) than in the teriparatide (6·2% [4·6], p=0·0139) or denosumab (5·5% [3·3], p=0·0005) groups. Femoral-neck BMD also increased more in the combination group (4·2% [3·0]) than in the teriparatide (0·8% [4·1], p=0·0007) and denosumab (2·1% [3·8], p=0·0238) groups, as did total-hip BMD (combination, 4·9% [2·9]; teriparatide, 0·7% [2·7], p<0 2="" denosumab="" p="0·0011).</div">

Interpretation

Combined teriparatide and denosumab increased BMD more than either agent alone and more than has been reported with approved therapies. Combination treatment might, therefore, be useful to treat patients at high risk of fracture.

Funding

Amgen, Eli Lilly, National Center for Research Resources.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60856-9/abstract

骨質疏鬆症的藥物增加骨礦物質密度（BMD）和降低骨折但不完全排除骨折的風險。雙膦酸鹽結合蛋白同化製劑並沒有改善的療效。我們單獨比較teriparatide 和 denosumab 兩種藥物。

方法


從2009年9月至2011年1月，我們參加到這項隨機試驗，對照試驗的是絕經後婦女骨質疏鬆症。患者以1:1:1的比例分配，接受teriparatide每日20微克，每6個月60毫克的denosumab，或兩者兼而有之。對在0，3，6和12個月BMD的測定。婦女完成基線至少有一項研究後的訪問。在修改後的意向性治療做分析評估。這項試驗註冊是ClinicalTrials.gov，NCT00926380號。

發現


100個符合條件的婦女中有94（94％）完成訪問後，至少有一項研究基楚線。在12個月後。在聯合用藥組（9.1％，[SD3.9）比在teriparatide特立帕肽（6.2％[4.6]，P =0.0139）或denosumab狄諾塞麥（5.5％[3.3]，P= 0.0005）前位腰椎骨密度增加。
頸股骨組合用藥組（4.2％[3.0]）比在單用teriparatide特立帕肽者（0.8％[4.1]，P =0.0007）的骨密度也增加了更多。總髖部骨密度也是聯合用藥組骨密度增加了更多，單用denosumab狄諾塞麥（2.1％ [3.8]，P =0.0238）組，（，單用teriparatide特立帕肽，0.7％[2.7]，聯合用藥組合，4.9％[2.9]P <0數據博客逃脫-2 =“數據博客逃脫狄諾塞麥=”“數據博客逃脫-P=0.0011）。</ DIV>

解釋

聯合使用teriparatide特立帕肽和denosumab狄諾塞麥兩種藥可增加骨密度。這比僅單獨使用一種藥物更能增加骨密度。也超過任何已報導批准的治療法。因此，聯合兩種藥治療法可能是對治療高危險性骨折者十分有用的。

研究資金


Amgen公司，禮來，國家研究資源中心。

**********************************************************

Two Drugs Better Than One in Postmenopausal Osteoporosis

By Amy Orciari Herman

Combination therapy with teriparatide and the monoclonal antibody denosumab increases bone mineral density (BMD) to a greater extent than either drug alone in women with postmenopausal osteoporosis, according to an industry-funded study in the Lancet.

Researchers randomized 100 postmenopausal women with high fracture risk to receive subcutaneous teriparatide (daily), denosumab (every 6 months), or both for 1 year. At the end of treatment, posterior-anterior spine BMD had increased significantly more with combination therapy (9% increase from baseline) than with either agent alone (roughly 6% each). Femoral-neck BMD and total-hip BMD had also increased more with combination therapy.

"The BMD changes in the combined-therapy group were greater than have been reported with any approved therapies," the researchers write. They conclude that their findings "suggest that this specific combination of drugs could be a useful option in the treatment of patients with osteoporosis at especially high risk of fracture."

%%%%%%%%%%%%%%%%%%%%%%%

Joy,

 

I received "Physician's First Watch" email everyday and I do read them, selectively on those interest to me or I feel I should know and that will cover most of the articles news.  It is quite interesting that the email of my "Physican's First Watch" and the same one you sent me come together.

 

Reading daily email of article/news alert, and one of them comes from my daughter, I am a mighty proud father! How about that!

 

You're now the "mover" of the trend of osteoporosis treatment, with the bad publicity surrounding on bisphosphonates (which used to be the mainstream of the thrapy or the drug of choice), I think Prolia will take off, along with Forteo, which had been much less commonly used before.

 

Mom went to a piano recital (Mrs. Kisner's students), mom's Chinese student, Jonathan, is the only one playing organ.  Mrs. Kisner lamente that she could have the student like you any more.  And she was talking about your piano and organ; I wish she knew your article published in Lancet!

 

dad

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Date: Wed, May 15, 2013 at 7:22 AM
Subject: Pelvic Organ Prolapse Surgery / Doubts on Sodium / Combo Tx for Osteoporosis / More ...
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Physician's First Watch for May 15, 2013 David G. Fairchild, MD, MPH, Editor-in-Chief Effectiveness of Pelvic Organ Prolapse Surgery Deteriorates over Time IOM Report Notes Doubts on Dietary Sodium Recommendations Two Drugs Better Than One in Postmenopausal Osteoporosis Hysterectomy Not Associated with Heightened Cardiovascular Risk Factors Interview: Marathon Bombings' Lessons — Part 2 Featured in Journal Watch: Orlistat Probably Doesn't Cause Acute Liver Injury FDA Approves Oral Solution for Subarachnoid Hemorrhage Effectiveness of Pelvic Organ Prolapse Surgery Deteriorates over Time By Kelly Young Long-term follow-up of pelvic organ prolapse repair reveals a failure rate that increases over time, a JAMA study finds. Some 200 women undergoing abdominal sacrocolpopexy for pelvic organ prolapse were randomized to prophylactic anti-incontinence surgery (Burch urethropexy) or no urethropexy. At 7 years, the probability of pelvic organ prolapse failure was 48% with urethropexy and 34% without urethropexy — not a significant difference. Failure rates gradually increased over the course of the study. Urethropexy reduced the likelihood of stress urinary incontinence. Overall, there was a 10% chance of mesh erosion. The authors conclude, "Women considering abdominal sacrocolpopexy should be counseled that this procedure effectively provides relief from [pelvic organ prolapse] symptoms; however, the anatomic support deteriorates over time." An editorialist writes, "This study has important clinical implications and calls into question the designation of the abdominal sacrocolpopexy as the criterion standard procedure for prolapse repair." JAMA article (Free abstract) JAMA editorial (Subscription required) Background: Journal Watch Women's Health summary of study's early findings (Your Journal Watch registration required) Top IOM Report Notes Doubts on Dietary Sodium Recommendations By Amy Orciari Herman New research supports the health benefits of lowering sodium intake from very high levels to more moderate levels (i.e., 2300 mg/day), according to an Institute of Medicine (IOM) report, but reducing intake too much might actually be detrimental to one's health. Current guidelines recommend a 2300 mg daily limit for those at average risk, and a 1500 mg limit for higher-risk individuals such as blacks, adults over age 50, and those with diabetes or kidney disease. The new IOM report concludes that evidence is insufficient to determine whether lowering intake below 2300 mg raises or lowers cardiovascular risk in the general population. 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At the end of treatment, posterior-anterior spine BMD had increased significantly more with combination therapy (9% increase from baseline) than with either agent alone (roughly 6% each). Femoral-neck BMD and total-hip BMD had also increased more with combination therapy. "The BMD changes in the combined-therapy group were greater than have been reported with any approved therapies," the researchers write. They conclude that their findings "suggest that this specific combination of drugs could be a useful option in the treatment of patients with osteoporosis at especially high risk of fracture." Lancet article (Free abstract) Lancet comment (Subscription required) Background: Journal Watch Women's Health summary of previous study on combo therapy with a bisphosphonate (Your Journal Watch registration required) Top Hysterectomy Not Associated with Heightened Cardiovascular Risk Factors By Joe Elia Women who undergo elective hysterectomy experience changes in cardiovascular risk factors similar to those observed after natural menopause, according to a study in the Journal of the American College of Cardiology. The finding contrasts with previous research showing increased risks after hysterectomy. Researchers followed some 2000 women through menopause or elective hysterectomy annually for up to 11 years. Risk factors at baseline and following the final menstrual period were compared between those undergoing surgery (with or without oophorectomy) and natural menopause. Changes were noted in both groups, "but not in a pattern suggesting increasing cardiovascular risk following hysterectomy." The authors conclude that their results "should provide reassurance to women and their clinicians that hysterectomy with or without ovarian conservation in mid-life is not likely to substantially accelerate women's [cardiovascular] risk." Journal of the American College of Cardiology online-first page (Free) Top Interview: Marathon Bombings' Lessons — Part 2 By Joe Elia Clinical Conversations continues its series of brief interviews on the lessons learned from the Boston Marathon bombings. This one is with Alasdair Conn, chief of emergency services at Massachusetts General Hospital. Clinical Conversations podcast (Free) Last week's interview with Dr. Ron Walls (Free) Top Featured in Journal Watch: Orlistat Probably Doesn't Cause Acute Liver Injury By The Journal Watch Editors Risk for liver injury was similar in the 90 days before and 90 days after patients' first prescriptions for orlistat (Alli) in a study published in BMJ. Journal Watch General Medicine summary (Free) Top FDA Approves Oral Solution for Subarachnoid Hemorrhage By The Editors The FDA has approved a nimodipine oral solution (marketed as Nymalize) to treat subarachnoid hemorrhage. The drug was previously only available in gel-capsule form. Regulators say they hope the new oral formulation, which can also be given via nasogastric tube, will reduce medication errors caused by healthcare providers injecting the liquid contents of the nimodipine capsules intravenously. FDA news release (Free) Top Physician Editors contributing to this issue were: David G. Fairchild, MD, MPH, and Richard Saitz, MD, MPH, FACP, FASAM. Physician's First Watch is editorially independent and does not endorse any company, publication, product, or service. This e-mail was sent to: JERKATY@GMAIL.COM Unsubscribe from this alert or update your preferences at My Alerts. Journal Watch: 860 Winter Street, Waltham, MA 02451, USA Copyright © 2013. Massachusetts Medical Society. All rights reserved.