Osteonecrosis News and Research

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Amgen announces primary results from XGEVA Phase 3 trial in castrate-resistant prostate cancer

Amgen today announced primary results of a pivotal Phase 3 trial demonstrating that XGEVA significantly increased bone metastasis-free survival for more than four months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone.

18 May 2011

Prolia associated with greater adherence than alendronate in postmenopausal women with osteoporosis

Amgen today announced new data that showed postmenopausal women with osteoporosis had significantly greater adherence, compliance, and persistence during Prolia® (denosumab) treatment than during alendronate treatment, an oral bisphosphonate commonly used to treat osteoporosis.

24 Mar 2011

The Lancet journal publishes XGEVA Phase 3 study results against prostate cancer, bone metastases

Amgen today announced the publication of results from a Phase 3 head-to-head trial that compared XGEVA to Zometa in preventing bone complications called skeletal-related events in 1,901 men with prostate cancer and bone metastases.

25 Feb 2011

Amgen announces publication of XGEVA Phase 3 study results against solid tumors in Journal of Clinical Oncology

Amgen today announced the publication of results from a pivotal Phase 3 study of 1,776 advanced cancer patients with different types of solid tumors or multiple myeloma, which compared XGEVA to Zometa in preventing skeletal-related events.

23 Feb 2011

State court jury rules in favor of Merck in FOSAMAX trial

Merck & Co., Inc. today said a state court jury in New Jersey found in its favor in the Rosenberg v. Merck case, rejecting the claims of a woman who blamed her dental and jaw related problems on her FOSAMAX use.

15 Feb 2011

Oral bisphosphonates outweigh the risk associated with jaw disease

A commonly prescribed osteoporosis drug is associated with a slightly elevated risk of developing the rare, but serious condition, osteonecrosis of the jaw; nonetheless the risk remains extremely low. These findings are published online in the Journal of Dental Research, the official journal of the International and American Associations for Dental Research.

14 Feb 2011

JDR releases research report on Osteonecrosis of the jaw

Osteonecrosis of the jaw is a debilitating bone condition that affects the jaws and occurs as a result of reduced local blood supply to the bone. The literature in this area has been severely limited since most investigations cannot evaluate sufficient numbers of afflicted individuals to accurately determine the incidence of the disease and associated risk factors.

14 Feb 2011

FDA stops pain drug trial over safety concerns

Johnson & Johnson revealed Tuesday this week that a clinical trial of its experimental pain drug, fulranumab, has been stopped after the Food and Drug Administration expressed concerns that patients taking the drug could suffer increased joint damage.

29 Dec 2010

Denosumab delays skeletal-related side effects in patients with breast cancer and bone metastases

For patients with breast cancer and bone metastases, denosumab delayed skeletal-related side effects five months longer compared to those on zoledronic acid, according to results presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held Dec. 8-12.

13 Dec 2010

Zometa improves OS, PFS in newly diagnosed multiple myeloma patients: Phase III study

A newly published study in the Lancet suggested that a first-line treatment regimen including Zometa (zoledronic acid) significantly improved overall survival and progression-free survival in newly diagnosed multiple myeloma patients compared with a regimen that included oral clodronate. The impact on survival was independent of the effect of Zometa on bone complications (also known as skeletal-related events or SREs).

4 Dec 2010

Merck wins third FOSAMAX bellwether trial

Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. With today's verdict, Merck has won three of the first four bellwether cases in the FOSAMAX litigation.

20 Nov 2010

Xgeva receives FDA approval for prevention of SREs in patients with bone metastases

The U.S. Food and Drug Administration approved Xgeva (denosumab) on Thursday to help prevent skeletal-related events (SREs) in patients with cancer that has spread (metastasized) and damaged the bone. Skeletal-related events include bone fractures from cancer and bone pain requiring radiation.

19 Nov 2010

Denosumab superior to Zometa in preventing SREs in breast cancer patients with bone metastases: Study

Amgen today announced the publication of results from a pivotal Phase 3 study of 2,046 patients which compared denosumab with Zometa® (zoledronic acid) in delaying or preventing skeletal-related events (SREs) in breast cancer patients with bone metastases. An SRE consists of any of the following: a pathologic fracture, the need for radiation or surgery to ameliorate bone pathology secondary to tumor growth, or spinal cord compression.

8 Nov 2010

Amgen wins Scrip Best New Drug award for Prolia

Amgen is pleased to announce that it has won the Best New Drug award for Prolia™ (denosumab), a novel treatment approved in the United States (U.S.) for women with postmenopausal osteoporosis at high risk for fracture, at the 2010 Scrip Awards ceremony Nov. 4 in London. Named one of TIME's Top 10 Medical Breakthroughs of 2009, Prolia is the first treatment specifically designed to target osteoclasts, the cells that break down bone.

8 Nov 2010

Novartis announces six-year data of Reclast injection for postmenopausal women with osteoporosis

Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis.The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

19 Oct 2010

New data on Merck’s odanacatib for osteoporosis in postmenopausal women presented at 32nd ASBMR

New data on odanacatib, an investigational cathepsin-K (Cat-K) inhibitor in development for the treatment of osteoporosis in postmenopausal women, were presented at the 32nd Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, Canada.

19 Oct 2010

Six-year data of reinforces efficacy and safety of Reclast injection in postmenopausal women with osteoporosis

Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis. The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

18 Oct 2010

Amgen to present oncology portfolio results at ESMO Congress

Amgen today announced that results from several important studies from the Company's ncology portfolio will be presented at the 35th European Society for Medical Oncology (ESMO) Congress, Oct. 8-12, 2010, in Milan, Italy.

6 Oct 2010

Merck to appeal against jury verdict in retrial of federal FOSAMAX case

Merck & Co., Inc. today said it will appeal a decision by the U.S. District Court for the Southern District of New York that reduced the jury verdict from $8 million to $1.5 million but denied Merck's request for judgment in its favor or a new trial in the case of Boles v. Merck, a retrial of a federal FOSAMAX case.

5 Oct 2010

Tasigna receives approval for chronic myeloid leukemia in Canada

Tasigna (nilotinib) capsules have been approved with conditions in Canada as a new therapy for patients with CML, in the chronic phase (first phase) of the disease. Patients must be resistant to or intolerant of at least one prior therapy, including (Pr)Gleevec (imatinib mesylate), an established standard of care.

20 Aug 2010