Osteopenia News and Research

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Osteopenia is a condition where bone mineral density is lower than normal. It is considered by many doctors to be a precursor to osteoporosis. However, not every person diagnosed with osteopenia will develop osteoporosis. More specifically, osteopenia is defined as a bone mineral density T-score between -1.0 and -2.5.

FDA extends PDUFA action date for NPS Gattex NDA

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has received a communication from the U.S. Food and Drug Administration extending the Prescription Drug User Fee Act action date for its New Drug Application for Gattex (teduglutide) by three months to December 30, 2012.

13 Aug 2012

Radiotherapy redundant in low-risk Hodgkin lymphoma treatment

Children with low-risk Hodgkin lymphoma who respond well to chemotherapy may not require additional radiotherapy, suggest study results.

10 Jul 2012

Platelet activation linked to osteoporosis

Elderly, postmenopausal women with osteoporosis have elevated platelet volumes, report researchers.

2 Jul 2012

European CHMP adopts positive opinion for teduglutide to treat short bowel syndrome

Takeda Pharmaceutical Company Limited and NPS Pharmaceuticals, Inc., jointly announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product teduglutide (Revestive) as a once-daily treatment for adult patients with short bowel syndrome (SBS).

22 Jun 2012

$Fragility fractures predicted to more than double in Latin America$

Fragility fractures predicted to more than double in Latin America

The International Osteoporosis Foundation (IOF), in cooperation with medical and patient societies from throughout Latin America, has today published a landmark report which compiles osteoporosis-related data on 14 countries and the region as a whole. The report shows that fragility fractures due to osteoporosis are predicted to more than double in some countries in the coming decades.

25 May 2012

Gattex may represent new treatment approach for short bowel syndrome

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today reported the presentation of data at the Digestive Disease Week (DDW) meeting held May 19-22 in San Diego.

22 May 2012

Osteopenia/osteoporosis more prevalent among male patients with pulmonary disease

There is a very high prevalence of osteopenia/osteoporosis among male patients with pulmonary disease, according to a new study from researchers in California.

21 May 2012

Studies show vitamin D may benefit cardiovascular, skin and metabolic disorders

The Endocrine Society's new scientific statement published online today represents the first comprehensive evaluation of both the basic and clinical evidence related to the non-skeletal effects of vitamin D. The statement addresses current research regarding the associations of vitamin D with immune function, hypertension, stroke, skin conditions and maternal/fetal health.

19 May 2012

Tarsa advances OSTORA NDA filing through $28M Series B financing

Tarsa Therapeutics, Inc. today announced completion of a $28 million Series B equity financing led by new investor Foresite Capital.

17 Mar 2012

Telephone-based counseling program does not improve osteoporosis medication adherence

Telephone motivational counseling sessions did not result in a statistically significant improvement in adherence to an osteoporosis medication regimen, according to a report published Online First by Archives of Internal Medicine, one of the JAMA/Archives journals.

28 Feb 2012

Research roundup: 'No individual mandate' scenarios; Breaking down health care expenditures

This paper expands 2011 research examining whether the health law's controversial individual mandate – which requires most people to have health insurance -- will be effective.

21 Jan 2012

Testing for osteoporosis – how often?

A new study shows that many women who get screened for osteoporosis may not need it. It suggests that the current guidelines result in too many unnecessary tests, increasing costs and sometimes spurring unnecessary treatment.

19 Jan 2012

Gilead Sciences receives FDA approval for Viread to treat pediatric HIV infection

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Viread in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-12.

19 Jan 2012

Growth hormone replacement increases bone formation in abdominally obese women

In a new study presented today at the annual meeting of the Radiological Society of North America (RSNA), growth hormone replacement for six months was found to increase bone formation in abdominally obese women.

29 Nov 2011

Many spinal fusion surgery patients have low levels of vitamin D

A new study indicates that many patients undergoing spine surgery have low levels of vitamin D, which may delay their recovery. In a study of 313 patients undergoing spinal fusion surgery, orthopaedic surgeons at Washington University School of Medicine in St. Louis found that more than half had inadequate levels of vitamin D, including one-fourth who were more severely deficient.

3 Nov 2011

NPS announces new data from GATTEX Phase 3 study on short bowel syndrome

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced new data from STEPS 2, a long-term open-label study, showing that GATTEX (teduglutide) was associated with achieving and maintaining clinically meaningful reductions in parenteral nutrition (PN) and intravenous (IV) fluid volume in adult subjects with short bowel syndrome.

1 Nov 2011

Tarsa reports positive data from OSTORA Phase III ORACAL trial for postmenopausal osteoporosis

Tarsa Therapeutics today reported that it presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA, the company's oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.

19 Sep 2011

Positive data from Tarsa's OSTORA Phase III trial on postmenopausal osteoporosis

Tarsa Therapeutics today presented positive safety and efficacy data from its Phase III ORACAL trial of OSTORA-, the company's oral recombinant salmon calcitonin tablet in development for the treatment of postmenopausal osteoporosis.

19 Sep 2011

FDA reviews safety issues of bisphosphonates for osteoporosis

An advisory committee for U.S. Food and Drug Administration meets Friday to review the safety of a popular class of osteoporosis drugs called bisphosphonates amid worry that their long-term use could cause rare fractures of the thighbones and affect the jawbone. The committee will evaluate whether women should temporarily stop using the drugs or use them for only a few years.

6 Sep 2011

NPS submits NDA CMC section to FDA for GATTEX

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has submitted the chemistry, manufacturing and controls (CMC) section of its new drug application (NDA) for GATTEX® (teduglutide) to the U.S. Food and Drug Administration (FDA).

18 Aug 2011