Full Text PA-97-009
 
OSTEOPOROSIS AND FRACTURES IN MEN
 
NIH GUIDE, Volume 25, Number 39, November 15, 1996
 
PA NUMBER:  PA-96-009
 
P.T. 34

Keywords: 
  0715031 

 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institute on Aging
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Dental Research
National Institute of Environmental Health Sciences
National Institute of Nursing Research
 
PURPOSE
 
This initiative invites applications directed to the study of the
basic biology, epidemiology, prevention and treatment of osteoporosis
and osteoporosis-related fractures in men.
 
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 PA,
Osteoporosis and Fractures in Men, is related to the priority areas
of diabetes and chronic disabling conditions and special population
objectives.  Potential applicants may obtain a copy of "Healthy
People 2000" (Full Report:  Stock No. 017-001-11474-0 or Summary
Report:  Stock No. 017-001-11473-1) through the Superintendent of
Documents, Government Printing Office, Washington, DC 20402-9325
(telephone 202-512-1800).
 
ELIGIBILITY REQUIREMENTS
 
Applications may be submitted by domestic and foreign, for-profit and
non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of state and local
governments, and eligible agencies of the Federal government.
Foreign institutions or organizations in foreign countries are not
eligible for First Independent Research Support Transitions (FIRST)
(R29) awards.  Applications from minority individuals and women are
encouraged.
 
MECHANISM OF SUPPORT
 
The support mechanisms for grants in this area will be the individual
investigator-initiated research project grant (R01) and the First
Independent
Research Support and Transition (FIRST) (R29) Award.
 
Applicants or collaborators from institutions that have a General
Clinical Research Center (GCRC) funded by the National Center for
Research Resources may wish to identify the GCRC as a resource for
conducting the proposed research.  If so, a letter of agreement from
either the GCRC program director should be included with the
application.
 
RESEARCH OBJECTIVES
 
Background
 
This Program Announcement is intended to address  the
under-representation of men in studies of osteoporosis.  Although 50
year old white males have about a 13 percent lifetime risk of
fractures of the hip, spine or wrist, the etiology and pathogenesis
of osteoporosis in males has received little research attention.  Men
are now much more likely to live into their eighth and ninth decade
than 20 years ago.  As other causes of early mortality  in men are
reduced, there is a need to focus on the chronic disabling conditions
that will limit independent life in elderly men.
 
Males are about a decade behind females in the manifestation of
osteoporosis and osteoporotic fractures. This has been attributed to
a higher peak bone mass at maturity and a more gradual diminution in
sex steroid influence in aging males.  At each age the rate of hip
fracture in men is about 50 percent that in women.  While this is
true in the United States and Northern Europe, in other parts of the
world the hip fracture rates are similar or even greater in men.  It
has been estimated that 1/3 of hip fractures world wide are in men.
Therefore hip fractures in men are an important and underscrutinized
area of public health.  With the decline in premature cardiovascular
mortality in males, fractures later in life are becoming an
increasingly important cause of morbidity and mortality in older men.
An Annotated Bibliography on  Osteoporosis in Men is available from
the National Osteoporosis and Related Bone Diseases National Resource
Center (phone 202-223- 0344)
 
Scope
 
The objective of this PA is to encourage and promote new and
innovative research and approaches to elucidate the basic biology,
epidemiology,  prevention and treatment of osteoporosis and
osteoporosis-related fractures in men.  For the purposes of this PA
skeletal includes craniofacial bone.  The following are examples of
research topics that are appropriate for this PA; however, they are
not to be considered as exclusive or limiting:
 
o  Examine skeletal developmental differences  in males and females
 
o  Investigate biomechanical and structural differences in males and
females of different races and ethnic groups that may illuminate the
etiology of fracture risk
 
o  Determine the risk factors for osteoporosis and fractures in men
 
o  Elucidate the etiologic factors in osteoporosis in men
 
o  Determine the calcium and vitamin requirements for optimal bone
growth, development and maintenance in men
 
o  Characterize the differences in the non-gonadal endocrine skeletal
regulatory mechanisms in men and women
 
o  Determine the prevalence of hypogonadism in men and its role in
the etiology of osteoporosis
 
o  Develop population based data sources for the prevalence of low
bone mass in males
 
The areas of interest listed above include  bone are not in any order
of priority.  They are only suggested examples of areas of research
to consider.  Applicants are encouraged to propose other areas that
are related to the objectives and scope of this PA.
 
INCLUSION OF MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
 
The inclusion of women is usually standard terminology for all grants
and contracts: however, due to the specific subject of this program
announcement, osteoporosis and fractures in men, the inclusion of
women is not applicable.  However, the inclusion of minorities
remains relevant.
 
It is the policy of the NIH that women and members of minority groups
and their sub-populations must be included in all NIH-supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification is provided
that inclusion is inappropriate with respect to the health of the
subjects or the purpose of the research.  This new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minority in Study Populations) which have
been in effect since 1990. The new policy contains some new
provisions that are substantially different from the 1990 policies.
 
All investigators proposing research involving human subjects should
read the "NIH Guidelines For Inclusion of Women and Minorities as
Subjects in Clinical Research," which have been published in the
Federal Register of March 28, 1994 (FR 59 14508-14513), and in the
NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18,
1994.
 
Investigators also may obtain copies of the policy from program staff
listed under INQUIRIES.  Program staff may also provide additional
relevant information concerning the policy.
 
APPLICATION PROCEDURES
 
Applications are to be submitted on the grant application form PHS
398 (rev. 5/95) and will be accepted at the standard application
deadlines as indicated in the application kit.  Applications kits are
available at most institutional offices of sponsored research and may
be obtained from the Grants Information Office, Office of Extramural
Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone
301/710-0267, email:  [email protected].
 
The title and number of the program announcement must be typed in
Section 2 on the face page of the application.
 
Applications for the FIRST Award (R29) must include at least three
sealed letters of reference attached to the face page of the original
application.  FIRST Award (R29) applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
 
The completed original application and five legible copies must be
sent or delivered to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by the
DRG. Incomplete applications will be returned to the applicant
without further consideration.
 
Applications will be assigned on the basis of established Public
Health Service referral guidelines. Applications will be reviewed for
scientific and technical merit by  an appropriate peer review group
convened in accordance with NIH peer review procedures.  As part of
the initial merit review, all applications will receive a written
critique and may undergo a process in which only those applications
deemed to have the highest scientific merit, generally the top half
of all applications under review, will be discussed, assigned a
priority score, and receive a second level review by the appropriate
national advisory council or board.
 
Review Criteria
 
o  scientific, technical, or medical significance and originality of
proposed research;
 
o  appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;
 
o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;
 
o  availability of the resources necessary to perform the research;
 
o  appropriateness of the proposed budget and duration in relation to
the proposed research; and
 
o  adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.
 
The Initial review group will also examine the provisions for the
protection of human subjects and animal welfare and the safety of the
research environment.
 
AWARD CRITERIA
 
Applications will compete for available funds with all other approved
applications assigned to NIAMS, NIA, NIDDK, NIDR, NIEHS, or NINR. 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 relevance and balance among research areas of the
announcement
 
INQUIRIES
 
Written and telephone inquiries are encouraged.  The opportunity to
clarify any issues or questions from potential applicants is welcome.
 
For scientific programmatic inquiries contact:
 
Joan A. McGowan, Ph.D.
Bone Diseases Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS-43E
45 Center Drive, MSC 4500
Bethesda, Maryland  20892-6500
Telephone: (301) 594-5055
FAX: (301) 480-4543
E-mail: [email protected]
 
Sherry Sherman, Ph.D.
Geriatrics Program
National Institute on Aging
Gateway Building, Suite 3E327
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1033
FAX:  (301) 402-1784
Email: [email protected]
 
Ronald N. Margolis, Ph.D.
Chief, Endocrinology Section
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
Building 45, Room 5AN-12J
45 CENTER DR
Bethesda, MD  20892-6600
Telephone:  (301) 594-8819
FAX:  (301) 480-3503
Email: [email protected]
 
Linda A. Thomas, Ph.D.
Director, Craniofacial Development and Disorders Program
National Institute of Dental Research
45 Center Drive, Room 4AN24J
Bethesda, MD  10892-6402
Telephone:  (301) 594-2425
FAX:  (301) 480-8138
E-mail: [email protected]
 
Annette Kirshner, Ph.D.
Bone Metabolism Program
National Institute of Environmental Health Sciences
Box 12233, MD 3-03
Research Triangle Park, North Carolina 27709
Office (919) 541-0488
Fax (919) 541-2843
e-mail: [email protected]
 
Laura James, PhD, RN
Division of Extramural Activities
National Institute of Nursing Research
Building 45, 3AN-12
Bethesda, MD 20892-6300
Telephone: (301) 594-5959
FAX: (3010 480-8260
Email: [email protected]
 
Direct inquiries regarding fiscal matters to:
 
Vicki Maurer
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS-49A
45 Center Drive, MSC 4500
Bethesda, Maryland  20892-6500
Telephone: (301) 594-3504
FAX: (301) 480-4543
E-mail:[email protected]
 
Joseph Ellis
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Suite 2N212
7201 Wisconsin Avenue, MSC 9205
Bethesda, MD  20892-9205
Telephone:  (301) 496-1472
FAX:  (301) 402-3672
Email: [email protected]
 
Kim Law
Grants Management Specialist
Building 45, Room 6AS-49A
National Institute of Diabetes and Digestive and Kidney Diseases
45 CENTER DR
BETHESDA, MD 20892-6600
Telephone:  (301) 594-8869
 
Martin R. Rubinstein
National Institute of Dental Research
45 Center Drive, Room 4AN44A
Bethesda, MD 20892-6402
Telephone (301)594-4800
FAX: (301) 480-480-8301
E-mail: [email protected]
 
David Mineo
Chief, Grants Management Branch
National Institute of Environmental Health Sciences
Box 12233, MD 2-01
Research Triangle Park, North Carolina 27709
Office (919) 541-7628
Fax (919) 541-2860
e-mail: [email protected]
 
Jeff Carow
Grants and Contracts Management Branch
National Institute of Nursing Research
Building 45, Room 3AN-32
Bethesda, MD 20892-6301
Telephone: (301) 594-5074
FAX:  (301) 480-8256
Email: [email protected]
 
AUTHORITY AND REGULATIONS
 
Awards made in this program are described in the Catalog of Federal
Domestic Assistance No. 93.846, 93.847, 93.866, 93.121, 93.113,
93.361.  Awards will be made under the authority of the Public Health
Service Act, Title III, Section 301 and Title IV, Part A (Public Law
410, 78th Congress, as amended, 42 USC 241) and administered under
PHS grant policies and Federal regulations 42 CFR Part 52 and 45 CFR
Part 74. This program is not subject to intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency
review.
 
The PHS strongly encourages all grant and contract recipients to
provide a smoke-free workplace and promote the non-use of all tobacco
products.  In addition, Public Law 103-227, the Pro-Children Act of
1994, prohibits smoking in certain facilities (or in some cases, any
portion of a facility) in which regular or routine education,
library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS
mission to protect and advance the physical and mental health of the
American people.
 
.

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