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ADVANCE/Metra Assay Demonstrates Predictive Value for Hip Fractures; Biochemical Marker May Be Used to Determine Elderly Women at Increased Risk for Hip Fracture.


MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Sept. 12, 1995--Metra
me·trae (-tr) 
See uterus.
 Biosystems Inc. (Nasdaq:MTRA MTRA - Manitoba Therapeutic Recreation Association (Canada)
MTRA - Marion Therapeutic Riding Association, Inc.
MTRA - Medical Technical Research Associates (San Bruno, CA)
MTRA - Medizinisch Technische Radiologie Assistentinnen
MTRA - Michigan Therapeutic Recreation Association
MTRA - Midwest Trail Riders Association
MTRA - Military Temporary Reserved Airspace
MTRA - Minnesota Trail Riders Association
MTRA - Model Thoroughbred Racing Association
) announced that data from a French study released today suggest the Company's Pyrilinks(R)-D assay can be used to assess increased risk of hip fracture. Results from the study were presented today by Pierre D. Delmas, MD, PhD, Professor of Medicine at Claude Bernard University of Lyon, Director of France's INSERM INSERM - Institut National de la Santé et de la Recherche Médicale (French Institute of Health and Medical Research) Unit 403, Hopital E. Herriot, at the Annual meeting of the American Society for Bone and Mineral Research. The data presented by Dr. Delmas result from a five-center French study (EPIDOS EPIDOS - European Patent Information and Documentation Systems) that enrolled 7,598 healthy women over 75 years of age, 95 percent of whom lived independently. The study compared a subgroup of 126 women who sustained a hip fracture during the 22-months following enrollment with two control groups: similarly-aged women; and premenopausal controls.

Levels of free deoxypyridinoline (free-Dpyr) measured using Metra's Pyrilinks-D assay were higher in patients who experienced a hip fracture than age-matched controls by a statistically significant amount. Free-Dpyr (Pyrilinks-D) levels above the upper limit of the premenopausal range also were associated with a statistically significant 1.7-fold greater risk of hip fracture (odds ratio). Levels of type I collagen C-telopeptide in urine (Crosslaps) also were increased. In contrast, no other bone marker used was predictive of the subsequent risk of hip fracture, i.e., crosslinked N-telopeptide of type I collagen (NTX) for resorption, or total osteocalcin (OC) and bone-specific alkaline phosphatase
leukocyte alkaline phosphatase phosphatase /phos·pha·tase/ (-tas) any of a group of enzymes that catalyze the hydrolytic cleavage of inorganic phosphate from esters.

phos·pha·tase (fs
  (LAP) the isozyme of alkaline phosphatase occurring in the leukocytes, specifically in the neutrophils; LAP activity is used in the differential diagnosis of neutrophilia, being lowered in chronic myelogenous leukemia but elevated in a variety of other disorders.


alkaline phosphatase
n.
A phosphatase with an optimum functioning at pH 8.
 (BAP BAP - 1. An early system used on the IBM 701.

[Listed in CACM 2(5):16 (May 1959)].
) for bone formation. All biochemical markers were higher in elderly women than the premenopausal group.

"We are very excited that the results from this study suggest our Pyrilinks-D assay can help predict which patients may be at increased risk for hip fracture," said George W. Dunbar, President and CEO of Metra Biosystems. "Metra's Pyrilinks-D assay is currently available for research use in the United States, and is under review by the U.S. Food and Drug Administration."

Elderly women with both hip bone mineral density bone mineral density
n.
See bone density.
 in the lowest quartile of those enrolled in the study, and either free-Dpyr (Pyrilinks-D) or type I collagen C-telopeptide elevated above the upper limit of the premenopausal range had a 3.8-fold increase in risk of hip fracture. This further suggests that the assessment of bone resorption may be useful in identifying elderly women at higher risk of hip fracture when combined with hip bone mineral density measurement.

Metra Biosystems has developed a panel of biochemical bone markers to help physicians more precisely assess a patient's bone turnover. Bone metabolism normally stays in careful balance, maintaining healthy, strong bones. When the rate or balance of bone metabolism is disrupted, a variety of bone diseases occur, including Paget James 1814-1899.
British surgeon and pathologist who discovered (1834) the parasitic worm that causes trichinosis, described (1874) Paget's disease of the breast, and identified (1877) osteitis deformans.
's disease and osteoporosis. Metra Biosystems has developed two assays, Alkphase-B(TM) and NovoCalcin(TM), for measuring bone formation and two assays, Pyrilinks and Pyrilinks-D, that measure bone resorption (loss). A fifth assay, Prolagen-C(R), is used to assess bone formation and growth and manage therapy for growth deficiencies. Alkphase-B received marketing clearance from the U.S. Food and Drug Administration for management of Paget's disease on August 29, 1995. NovoCalcin, Pyrilinks, Pyrilinks-D and Prolagen-C are currently available for research use in the U.S. and for clinical use abroad.

Metra Biosystems is based in Mountain View, CA, with a European headquarters in Oxford, U.K. The Company is a leader in the development and commercialization of diagnostic products for the detection and management of metabolic bone diseases and disorders. The Company's strategy is to offer a portfolio of tests that will provide physicians with comprehensive clinical information regrading the metabolism of bone and other connective tissues, and growth disorders.

(End of advance for release 1:30 pm Eastern time Sept. 12)

CONTACT: Metra Biosystems, Mountain View, Calif.

Colette Andrea, 415/903-9100

or

Metra Biosystems, Oxford, UK

John Coombes, 441/865 875 557

or

Burns McClellan, New York

Scott Storbo, 212/505-1919

sstorbo@burnsmc.com
COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Sep 11, 1995
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