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United States Patent

Weinstein et al.

[19]

US006029078A [ii] Patent Number: 6,029,078 [45] Date of Patent: *Feb. 22,2000

[54] SYSTEM FOR ASSESSING BONE CHARACTERISTICS

[75] Inventors: Joel B. Weinstein, Framington; Donald Barry, Norwood, both of Mass.

[73] Assignee: Hologic, Inc., Bedford, Mass.

[ * ] Notice: This patent is subject to a terminal disclaimer.

[21] Appl. No.: 09/013,361 [22] Filed: Jan. 23, 1998

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IGEA, DBM Sonic 1200 Brochure (undated). "Bone" Official Journal of the International Bone and Mineral Society, vol. 16, No. 1, pp. 246-249 Jan. 1995. Ultrasound Assessment of Bone Fragility in the Climacteric Women by DBM Sonic 1200, Mura Marta. Perth International Bone Meeting, Bone Fragility in the Year 2000, p. 65 (Feb. 1995).

Connective Tissue Changes in the Menopause, M. Brincat et al.

Minhorst Osteoson brochure (May 1995).
Minhorst Osteoson K IV brochure (undated).
Ultrasound for Bone Measurement, A Private Symposium,
Lunar, Apr. 1992.

(List continued on next page.)

Primary Examiner—Francis J. Jaworski

Attorney, Agent, or Firm—Cooper & Dunham LLP

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A system and method for determining bone characteristic data is provided. The system combines a biochemical bone measuring unit with a densitometric bone measuring unit to determine the bone characteristic data. Once the bone characteristic data is ascertained, a determination of whether bone formation or bone resorption is occurring is made and future bone characteristics can be projected.

46 Claims, 19 Drawing Sheets

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OTHER PUBLICATIONS

Lunar, Achilles Ultrasound Bone Densitometer brochure (undated).

Clinical Investigations, "Preliminary Evaluation of a New Ultrasound Bone Densitometer" by Belinda Lees and John C. Stevenson, Calif Tissue Int. 1993. Report on "Ultrasonic Assessment of Bone III", May 1993. Observations at ASBMR, by G.H. Brandenburger, 1991. "Ultrasound Measurements of the Os Calcis", by R. Mazes et al., Presented at the Third Bath Conference on Osteoporosis and Bone Mineral Measurement (Jun. 1992). Perth International Bone Meeting, Bone Fragility in the Year 2000: Clinical Measurement, p. 63 (Feb. 1995). Perth International Bone Meeting, Bone Fragility in the Year 2000: Clinical Measurement, p. 61 (Feb. 1995). Abstract of "Applications of an enzyme immunoassay for a new marker of bone resorption", by M. Bonde, et al., J. Clin Endocrinol Metab Mar. 1995; 80(3) : 864-8. Abstract of "Estimation of the effect of salmon calcitonin in established osteoporosis by biochemical bone markers", by NM Nielsen, et al, Calcif Tissue Int. Jul. 1994;55(1):8-11.

Abstract of "Postmenopausal bone loss and the risk of osteoporosis", by C. Christiansen, Osteoporos Int. 1994;4 Suppl 1:47-51.

Abstract of "The diagnostic validity of urinary free pyridinolines to identify women at risk of osteoporosis", by C. Fledelius, et al, Calcif Tissue Int May 1994; 54(5):381-4. Abstract of "The carboxy-terminal pyridinoline cross-linked telopeptide of type I collagen in serum as a marker of bone resorption: the effect of nandrolone decanoate and hormone replacement therapy", by C. Hassager, et al., Calcif Tissue Int Jan. 1994;54(l):30-3. "Osteoporosis: Diagnosis and Management Today and Tomorrow", by C. Christiansen, Bone, vol. 17, No. 5, Suppl. Nov. 1995:513S-516S.

"Postmenopausal Bone Loss and the risk of Osteoporosis", by C. Christiansen, Osteoporosis Int. vol. 4 (1994) Suppl. LS47-51.

"Biochemical Markers of Bone Turnover to Monitor the Bone Response to Postmenopausal Hormone Replacement Therapy", by B.J. Riis, et al., Osteoporosis Int. vol. 5, No. 4 (1995) pp. 276-280.

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