I

104TH CONGRESS

2D SESSION H. R. 3331

To amend the Public Health Service Act to expand and intensify programs

of the National Institutes of Health with respect to research and related

activities concerning osteoporosis and related bone diseases.

IN THE HOUSE OF REPRESENTATIVES

APRIL 25, 1996

Ms. EDDIE BERNICE JOHNSON of Texas (for herself, Mrs. MORELLA, Mr.

HAYES, Mr. GENE GREEN of Texas, Ms. WATERS, Mr. HILLIARD, Mrs.

MEEK of Florida, Mr. FROST, Mrs. CLAYTON, Ms. LOFGREN, Ms. NORTON, Mr. FRAZER, Mr. THOMPSON, Mr. TOWNS, Miss COLLINS of Michigan, Mr. EVANS, and Mrs. KENNELLY) introduced the following bill;

which was referred to the Committee on Commerce

A BILL

To amend the Public Health Service Act to expand and

intensify programs of the National Institutes of Health

with respect to research and related activities concerning

osteoporosis and related bone diseases.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Osteoporosis and Re5 lated Bone Diseases Research Act of 1996’’.
2

•HR 3331 IH

1 SEC. 2. FINDINGS.

2 The Congress finds that—

3 (1) osteoporosis, or porous bone, is a condition

4 characterized by an excessive loss of bone tissue and

5 an increased susceptibility to fractures of the hip,

6 spine, and wrist;

7 (2) osteoporosis is a threat to an estimated

8 25,000,000 Americans, 80 percent of whom are

9 women, many of whose cases go undiagnosed be10 cause the condition develops without symptoms until

11 a strain, bump, or fall causes a fracture;

12 (3) between 3 and 4 million Americans have

13 Paget’s disease, osteogenesis imperfecta,

14 hyperparathyroidism, and other related metabolic

15 bone diseases;

16 (4) osteoporosis is responsible for 1,500,000

17 bone fractures annually, including more than

18 250,000 hip fractures, 500,000 vertebral fractures,

19 200,000 fractures of the wrist, and the remaining

20 fractures at other limb sites;

21 (5) 1 of every 2 women and 1 of every 8 men

22 over age 50 will develop fractures associated with

23 osteoporosis;

24 (6) direct medical costs of osteoporosis are esti25 mated to be $10,000,000,000 annually for the Unit-
3

•HR 3331 IH

1 ed States, not including the costs of family care and

2 lost work for caregivers;

3 (7) direct medical costs of osteoporosis are ex4 pected to increase precipitously because the propor5 tion of the population comprised of older persons is

6 expanding and each generation of older persons

7 tends to have a higher incidence of osteoporosis than

8 preceding generations;

9 (8) technology now exists, and new technology

10 is developing, that will permit early diagnosis and

11 prevention of osteoporosis as well as management of

12 the condition once it has developed;

13 (9) funding for research on osteoporosis and re14 lated bone diseases is severely constrained at key re15 search institutes, including the National Institute of

16 Arthritis and Musculoskeletal and Skin Diseases, the

17 National Institute on Aging, the National Institute

18 of Diabetes and Digestive and Kidney Diseases, the

19 National Institute of Dental Research, and the Na20 tional Institute of Child Health and Human Devel21 opment;

22 (10) further research is needed to improve med23 ical knowledge concerning—

24 (A) cellular mechanisms related to the

25 processes of bone resorption and bone forma-
4

•HR 3331 IH

1 tion, and the effect of different agents on bone

2 remodeling;

3 (B) risk factors for osteoporosis, including

4 newly discovered risk factors, risk factors relat5 ed to groups not ordinarily studied (such as

6 men and minorities), risk factors related to

7 genes that help to control skeletal metabolism,

8 and risk factors relating to the relationship of

9 aging processes to the development of

10 osteoporosis;

11 (C) bone mass measurement technology,

12 including more widespread and cost-effective

13 techniques for making more precise measure14 ments and for interpreting measurements;

15 (D) calcium (including bioavailability, in16 take requirements, and the role of calcium in

17 building heavier and denser skeletons), and vi18 tamin D and its role as an essential vitamin in

19 adults;

20 (E) prevention and treatment, including

21 the efficacy of current therapies, alternative

22 drug therapies for prevention and treatment,

23 and the role of exercise; and

24 (F) rehabilitation; and
5

•HR 3331 IH

1 (11) further educational efforts are needed to

2 increase public and professional knowledge of the

3 causes of, methods for avoiding, and treatment of

4 osteoporosis.

5 SEC. 3. OSTEOPOROSIS RESEARCH.

6 Subpart 4 of part C of title IV of the Public Health

7 Service Act (42 U.S.C. 285d et seq.) is amended by adding

8 at the end the following new section:

9 ‘‘SEC. 442A. RESEARCH ON OSTEOPOROSIS AND RELATED

10 DISEASES.

11 ‘‘(a) EXPANSION OF RESEARCH.—The Director of

12 the Institute, the Director of the National Institute on

13 Aging, the Director of the National Institute of Diabetes

14 and Digestive and Kidney Diseases, the Director of the

15 National Institute of Dental Research, and the Director

16 of the National Institute of Child Health and Human De17 velopment shall expand and intensify research on

18 osteoporosis and related bone diseases. The research shall

19 be in addition to research that is authorized under any

20 other provision of law.

21 ‘‘(b) MECHANISMS FOR EXPANSION OF RESEARCH.—

22 Each of the Directors specified in subsection (a) shall, in

23 carrying out such subsection, provide for one or more of

24 the following:

25 ‘‘(1) Investigator-initiated research.
6

•HR 3331 IH

1 ‘‘(2) Funding for investigators beginning their

2 research careers.

3 ‘‘(3) Mentorship research grants.

4 ‘‘(4) Specialized centers.

5 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

6 are authorized to be appropriated to carry out this section

7 $30,000,000 for the National Institute of Arthritis and

8 Musculoskeletal and Skin Diseases, $6,500,000 for the

9 National Institute on Aging, $6,500,000 for the National

10 Institute of Diabetes and Digestive and Kidney Diseases,

11 $4,000,000 for the National Institute of Dental Research,

12 and $3,000,000 for the National Institute of Child Health

13 and Human Development for each of the fiscal years 1997

14 through 1999, and such sums as may be necessary for

15 subsequent fiscal years. These funds are in addition to

16 amounts authorized to be appropriated for biomedical re17 search relating to osteoporosis and related bone diseases

18 under any other provision of law.

19 ‘‘(d) RELATED BONE DISEASES DEFINED.—As used

20 in this section, the term ‘related bone diseases’ includes—

21 ‘‘(1) Paget’s disease, a bone disease character22 ized by enlargement and loss of density with bowing

23 and deformity of the bones;

24 ‘‘(2) osteogenesis imperfecta, a familial disease

25 marked by extreme brittleness of the long bones;
7

•HR 3331 IH

1 ‘‘(3) hyperparathyroidism, a condition charac2 terized by the presence of excess parathormone in

3 the body resulting in disturbance of calcium metabo4 lism with loss of calcium from bone and renal dam5 age;

6 ‘‘(4) hypoparathyroidism, a condition character7 ized by the absence of parathormone resulting in

8 disturbances of calcium metabolism;

9 ‘‘(5) renal bone disease, a disease characterized

10 by metabolic disturbances from dialysis, renal trans11 plants, or other renal disturbances;

12 ‘‘(6) primary or postmenopausal osteoporosis

13 and secondary osteoporosis, such as that induced by

14 corticosteroids; and

15 ‘‘(7) other general diseases of bone and mineral

16 metabolism including abnormalities of vitamin D.’’.

Æ