Hypocalcemia News and Research

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Phase 3 trial demonstrates superiority of Amgen's denosumab over Zometa in preventing SREs

Amgen today announced detailed results from a Phase 3, head-to-head trial which compared the efficacy and safety of denosumab versus Zometa® (zoledronic acid) in 1,901 patients with hormone-refractory prostate cancer and bone metastases. The study met its primary and secondary endpoints and demonstrated denosumab's superiority over Zometa in delaying or preventing skeletal related events (SREs).

7 Jun 2010

Positive results from new analyses of denosumab Phase 3 trials

Amgen today announced positive results from several new analyses of two Phase 3 trials studying denosumab compared with Zometa® (zoledronic acid), the current standard of care, for the treatment of bone metastases in patients with advanced breast cancer ("136 study") and solid tumors or multiple myeloma ("244 study"). Results from these trials reinforce denosumab's consistent ability to delay the complications of bone metastases in patients with advanced cancer. These results are being presented during the 2010 American Society of Clinical Oncology Annual Meeting in Chicago.

5 Jun 2010

NPS Pharmaceuticals supports second annual U.S. Rare Disease Day observance

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today its support for the second annual U.S. Rare Disease Day observance on February 28.

1 Mar 2010

Denosumab exhibits superiority over Zometa in treatment of prostate cancer men with bone metastases

Amgen today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa® (zoledronic acid) in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints.

9 Feb 2010

Hyperphosphatemia following standard OSP doses is related to weight, reveals study

Colon cleansing is used widely for colonoscopic exploration and colonic and gynecological surgery. Oral sodium phosphate (OSP) solution is the osmotic laxative most commonly used for this purpose. It is known that OSP can induce severe hyperphosphatemia and hypocalcemia due to excessive absorption of phosphates, and there have been reports of deaths and irreversible dialysis-requiring renal insufficiency. However, no prospective studies have investigated the prevalence of hyperphosphatemia in low-risk patients.

18 Jan 2010

FDA approves Schering-Plough's New Drug Application for ZEGERID OTC capsules

Santarus, Inc., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Schering-Plough HealthCare Products, Inc.’s, New Drug Application (NDA) for ZEGERID OTC™ Capsules (omeprazole/sodium bicarbonate) with a dosage strength of 20 mg of omeprazole for over-the-counter (OTC) treatment of frequent heartburn.

2 Dec 2009

FDA grants marketing approval for Elitek

Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Elitek (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

19 Oct 2009

Book on pediatric bone disorders and mineral metabolism

Summarizing current knowledge, the physiology of calcium, magnesium and phosphate metabolism, the technique of bone biopsy and uses and pitfalls of bone density scanning are discussed. The main part of this publication describes in detail the disorders associated with hypocalcemia, hypercalcemia, rickets, phosphate metabolism, primary and secondary osteoporosis. The genetic nature of many of these conditions is highlighted and each condition is referred to by the number of its OMIM entry. The final chapter, which distinguishes this book from previous publications on the topic, comprises case reports illustrating some of the problems that are examined in previous chapters.

21 Sep 2009

Validus chooses Ranbaxy to market an authorized generic version of Rocaltrol in the US

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), Gurgaon, India, announced an agreement with Validus Pharmaceuticals LLC (Validus) to market and distribute an authorized generic version of Rocaltrol(R) (calcitriol) in both softgel capsules and an oral liquid formulation. Overall market sales for calcitriol softgel capsules and oral liquid were $70 million (IMS - MAT: June 2009).

2 Sep 2009

Thyroid cancer patients treated successfully using a new robot-assisted endoscopic technique

Using a novel robot-assisted endoscopic technique, a team of surgeons at Yonsei University College of Medicine in Seoul, Korea, has successfully treated 200 consecutive patients with thyroid cancer. The minimally invasive operation, which has several technical and cosmetic benefits that the traditional open operation does not offer, is described in the August issue of the Journal of the American College of Surgeons.

20 Aug 2009

FDA approves Actonel (risedronate sodium) for postmenopausal osteoporosis

The U.S. Food and Drug Administration (FDA) approved a new once-a-month dose (150 mg) of Actonel (risedronate sodium) tablets for the treatment and prevention of postmenopausal osteoporosis. Actonel is approved to reduce the risk of fractures in postmenopausal women with osteoporosis.

24 Apr 2008

$Untreated postmenopausal women with osteoporosis are at risk for first spinal fracture within one year$

Untreated postmenopausal women with osteoporosis are at risk for first spinal fracture within one year

Results of a new analysis found that, without treatment, one out of 13 postmenopausal osteoporotic women who were initially fracture-free were likely to experience a spinal fracture within one year.

28 Apr 2004