RESEARCH ON ORAL BONE LOSS AND OSTEOPOROSIS

NIH GUIDE, Volume 22, Number 30, August 20, 1993



PA NUMBER:  PA-93-104



P.T. 34



Keywords:

  0715031 

  Oral Diseases 



National Institute of Dental Research

National Institute of Arthritis and Musculoskeletal and Skin Diseases



PURPOSE



The National Institute of Dental Research (NIDR) and the National

Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

invite grant applications to conduct multidisciplinary research, both

basic and clinical, with emphasis on genetic and epidemiological

aspects of the link between osteoporosis and oral bone loss.



HEALTHY PEOPLE 2000



The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This Program

Announcement, Osteoporosis and Oral Bone Loss, is related to the

priority area of oral health.  Potential applicants may obtain a copy

of "Healthy People  2000" (Full Report:  Stock No. 017-001-00474-0)

or "Healthy People  2000" (Summary Report:  Stock No.

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238).



ELIGIBILITY REQUIREMENTS



Applications may be submitted by domestic and foreign, non-profit and

for-profit, public and private organizations, such as dental or

medical schools, universities and research institutions.  Foreign

institutions are not eligible for the First Independent Research

Support and Transition (FIRST) Award (R29).  Applications from

minority individuals and women are encouraged.



MECHANISM OF SUPPORT



The mechanisms available for the support of this program include the

research project grant (R01), First Independent Research Support and

Transition (FIRST) Award (R29), small grant (R03) (NIDR only), and

Interactive Research Project Grants (IRPG).



Applications from institutions that have an Osteoporosis Research

Center funded by the NIAMS may wish to identify the center as a

resource for conducting the proposed research.  If so, a letter of

agreement from both the center director and program director should

be included with the application.



RESEARCH OBJECTIVES



Osteoporosis is a major health problem in the United States affecting

an estimated 20 million people, many of whom are women. The disease

is implicated in 1.5 million fractures each year and accounts for

medical care expenditures of at least $10 billion annually.  In

addition, there is evidence of significant mortality and morbidity

associated with osteoporosis.  While little is known about the

possible relationship between oral bone loss and osteoporosis, the

scientific literature suggests that skeletal osteopenia, in concert

with underlying factors, may create an environment conducive to

accelerated loss of oral bone.  In the dentate this may be manifested

as a loss of tooth support.  In toothless (edentulous) individuals,

osteopenia may augment local anatomic, biological, and mechanical

factors resulting in extensive ridge atrophy.  Thus, skeletal

osteopenia may influence the need for and outcome of periodontal,

pre-prosthetic, and implant procedures.  There is also evidence in

the literature to suggest that therapeutic measures that control or

have an effect on osteoporosis could have a favorable impact on oral

bone retention.



An NIH workshop titled "Osteoporosis and Oral Bone Loss" was

sponsored by the National Institute of Dental Research, the National

Institute of Arthritis and Musculoskeletal and Skin Diseases, and the

Office of Research on Women's Health, to bring together experts from

various disciplines to focus attention on the possible relationship

between osteoporosis and oral bone loss.  The goal of the workshop

was to summarize the state of the science on this relationship, to

identify gaps in knowledge regarding possible linkages underlying the

relationship, and to develop specific research recommendations for

the future.  The complete proceedings of the workshop and the

research recommendations will be published in an upcoming supplement

to the Journal of Bone and Mineral Research.



While craniofacial bone may provide measurable features indicative of

skeletal bone health, studies specifically designed to examine the

relationship between craniofacial bone mass and osteoporosis have had

mixed results and have been plagued by methodological deficiencies

that cloud interpretation and prohibit comparison of results.  Thus,

many of our concepts are based on anecdotal information, clinical

impressions, and studies on small sample sizes.  Recognizing these

limitations, the literature shows that there is:  (1) a positive

correlation between tooth loss, edentulism, and osteoporosis; (2) a

relationship between skeletal, maxillary, and mandibular bone mass;

(3) annual decrease in jaw bone of elderly individuals, the rate of

decrease being greater in women than in men; (4) a significant

difference between younger and older women in maxillary and

mandibular alveolar bone; and (5) a significant difference in osseous

fractal dimensions in premenopausal and postmenopausal women.  Thus,

despite the limited data available, it was the consensus of the

workshop that the rate and severity of oral bone loss might be

accelerated by the presence of various forms of osteoporosis.  These

data as well as our knowledge of basic bone biology suggest a strong

rationale for a relationship between oral bone loss and osteoporosis.



The participants in the workshop on Osteoporosis and Oral Bone Loss

described the need for continued integration of insights from

collaborative studies carried out by specialists in oral biology and

medicine and experts in skeletal osteoporosis.  Some recommended

research directions include, but are not limited to:



o  Development of new and improved methods for quantitatively

assessing oral bone volume, density, structural and mechanical

properties, quality and turnover applicable to both dentate and

edentate individuals.  These methods should be suitable for large

scale population studies.



o  Development of in vitro and in vivo models for studying oral bone

loss and remodelling.  Models that investigate the effect of

mechanical, biophysical and metabolic influences on oral bone are

encouraged.



o  Identification and development of molecular markers present in the

oral cavity that can be used for the diagnosis of oral and non-oral

bone loss.



o  Development of basic knowledge on the similarities and differences

between oral and non-oral bone in health and disease and investigate

possible relationships between osteoporosis and oral bone loss.



o  Design of epidemiological and genetic studies to elucidate

possible linkages between oral bone loss and osteoporosis.



o  Development of simple, cost-effective, accurate and safe

diagnostic tests to ascertain individuals at risk for oral bone loss.



o  Conducting studies to clarify the role of fluorides in the

possible prevention of osteoporosis and, specifically, oral bone

loss.



o  Identification and characterization of association between

osteoporosis and periodontal diseases.



These areas of research are neither prioritized nor meant to be

restrictive.  Investigators are encouraged to submit scientifically

meritorious applications in any area of research responsive to the

general research objectives of this Program Announcement.



Research applications should be of high scientific quality.  The

project should be founded on a strong hypothesis as evidenced by

preliminary data collected by the investigator or others.  Prior

experience of the investigative team is an important element in

proving the likely success of the research proposed.



STUDY POPULATIONS



SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH

POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL

RESEARCH STUDY POPULATIONS



NIH policy is that applicants for clinical research grants and

cooperative agreements are required to include minorities and women

in study populations so that research findings can be of benefit to

all persons at risk of the disease, disorder or condition under

study; special emphasis should be placed on the need for inclusion of

minorities and women in studies of diseases, disorders and conditions

which disproportionately affect them.  This policy is intended to

apply to males and females of all ages.  If women or minorities are

excluded or inadequately represented in clinical research,

particularly in proposed population-based studies, a clear compelling

rationale must be provided.



The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample site appropriate for the scientific objectives of

the study.  This information should be included in form PHS 398 (rev.

9/91) in items 1-4 of the Research Plan and summarized in item 5,

Human Subjects. Applicants are urged to carefully assess the

feasibility of including the broadest possible representation of

minority groups.  However, NIH recognizes that it may not be feasible

or appropriate in all such projects to include representation of the

full array of United States racial, ethnic minority populations

(i.e., Native Americans [including American Indians or Alaskan

Natives], Asian/Pacific Islanders, Blacks, Hispanics).



The rationale for studies on single minority population groups should

be provided.



For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, epidemiology,

prevention (and preventive strategies), diagnosis, or treatment of

diseases, disorders or conditions, including but not limited to

clinical trials.



The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.



For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including

minorities.



If the required information is not contained within the application,

the application will be returned.



Peer reviewers will address specifically whether the research plan in

the application conforms to these policies. If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed or the justification for the

selected study population is inadequate, it will be considered a

scientific weakness or deficiency in the study design and will be

reflected in assigning the priority score to the application.



All applications for clinical research submitted to the NIH are

required to address these policies. NIH funding components will not

award grants or cooperative agreements that do not comply with these

policies.



APPLICATION PROCEDURES



Applications are to be submitted on grant application form PHS 398

(rev. 9/91), which may be obtained from the Office of Grants

Information, Division of Research Grants, National Institutes of

Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone

301/435-0714 and from the institution's office of sponsored research.

To identify the application as a response to this PA, check "yes" on

item 2a of face page of the application and enter PA-93-104

"Osteoporosis and Oral Bone Loss".



Applications for the R01 and R29 mechanisms will be accepted at the

standard applications receipt dates indicated in the application kit.



The application receipt date for R03s is April, August, and December

3.



The receipt dates for the IRPG mechanism (which was announced in the

NIH Guide, Vol. 22, No. 16, April 23, 1993) are February, June, and

October 15.



Submit a signed, typewritten original of the application, and five

signed photocopies, in one package to:



Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**



REVIEW CONSIDERATIONS



Applications will be assigned on the basis of established Public

Health Service referral guidelines.  Applications will be reviewed

for scientific and technical merit by initial review groups of the

Division of Research Grants, NIH or by the review group of the

relevant Institute in accordance with the standard NIH peer review

procedures. Following scientific-technical review, applications will

receive a second level review by the appropriate national advisory

council or board.



AWARD CRITERIA



Applications will compete for available funds with all other approved

applications assigned to that ICD.  The following will be considered

in making funding decisions:



o  Quality of the proposed project as determined by peer review

o  Availability of funds

o  Program balance among research areas of the announcement.



INQUIRIES



Written and telephone inquiries concerning this PA are encouraged.

The opportunity to clarify any issues or questions from potential

applicants is welcome.



Direct inquiries regarding programmatic issues to:



Mohandas Bhat, M.D.S., Dr.P.H.

Craniofacial Development and Disorders Program

National Institute of Dental Research

Westwood Building, Room 509

Bethesda, MD  20892

Telephone:  (301) 594-7648



Joan A. McGowan, M.N.S., Ph.D.

Bone Biology and Bone Diseases Branch

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Westwood Building, Room 403

Bethesda, MD  20892

Telephone:  (301) 594-9957

E-mail:  McGowanJ@occshost.NLM.NIH.GOV



Direct inquiries regarding fiscal matters to:



Ms. Theresa Ringler

Grants Management Office

National Institute of Dental Research

Westwood Building, Room 510

Bethesda, MD  20892

Telephone:  (301) 594-7629



Ms. G. Carol Clearfield

Grants Management Branch

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Westwood Building, Room 726B

Bethesda, MD  20892

Telephone:  (301) 594-9973



AUTHORITY AND REGULATIONS



This program is described in the Catalog of Federal Domestic

Assistance No. 93.121.  Awards are made under authorization of the

Public Health Service Act, Title IV, Part A (Public Law 78-410, as

amended by Public Law 99-158,(42 USC 241 and 285) and administered

under PHS grants policies and Federal Regulations 42 CFR 52 and 45

CFR Part 74.  This program is not subject to the intergovernmental

review requirements of Executive Order 12372 or Health Systems Agency

review.



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