Full Text HD-97-006
 
PREVENTION OF OSTEOPOROSIS
 
NIH GUIDE, Volume 26, Number 21, June 20, 1997
 
RFA:  HD-97-006
 
P.T. 34

Keywords: 
  Disease Prevention+ 
  0715031 

 
National Institute of Child Health and Human Development
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
Application Receipt Date:  September 5, 1997
 
PURPOSE
 
The National Institute of Child Health and Human Development (NICHD)
and the National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) invite studies of strategies to prevent
osteoporosis.  The purpose of this Request for Applications (RFA) is
to develop methods to prevent osteoporosis by physical activity and
dietary means in childhood.
 
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  RFA,
Prevention of Osteoporosis, is related to the priority areas of
nutrition and chronic disabling conditions.  Potential applicants may
obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1)
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, units of State and local governments, and
eligible agencies of the Federal government.  Foreign institutions
are not eligible for First Independent Research Support and
Transition (FIRST) (R29) awards.  Racial/ethnic from minority
individuals, persons with disabilities, and women are encouraged to
apply as Principal Investigators.
 
MECHANISM OF SUPPORT
 
The mechanisms available for support of applications in response to
this RFA will be through the National Institutes of Health (NIH)
Research Project Grant (R01) and FIRST Award (R29) programs.
Policies that govern the grants award programs of the PHS will
prevail.  The support of grants pursuant to the RFA is contingent
upon receipt of appropriated funds for this purpose.
 
This RFA is a one-time solicitation.  Future unsolicited competing
continuation applications will compete with all
investigator-initiated applications and will be reviewed by a
Division of Research Grants (DRG) study section.  However, if it is
determined that there is a sufficient continuing program need, the
sponsoring Institutes may announce a request for competitive
continuation applications.  The total project period for applications
submitted in response to this RFA may not exceed four years.  A
maximum of three years may be requested for foreign awards.  The
earliest anticipated award date is April 1, 1998.
 
FUNDS AVAILABLE
 
It is anticipated that four to six new grants will be awarded under
this program, contingent upon receipt of a sufficient number of
meritorious applications and the availability of funds.  The NICHD
and NIAMS have set aside $1.4 million for total costs in the first
year.
 
RESEARCH OBJECTIVES
 
Background
 
Osteoporosis afflicts an estimated 25 million Americans and generates
annual medical costs of about $13.8 billion. Osteoporotic fractures
result in substantial morbidity and mortality, but a significant
portion of the economic and human costs can be averted through
efforts at prevention. Peak bone mass is a major determinant of
fracture risk in later life.  Although genetic factors control most
of skeletal development, up to 20% of bone mass is regulated by
controllable factors such as nutrition and exercise.  Since
approximately 40% of the adult bone mineral content is accumulated
during adolescence, this is an extremely important time to focus on
practices that optimize skeletal health.
 
Although it is known that calcium and other nutrients in dairy
products contribute to the development of a healthy skeleton, results
of the USDA Household Survey and the NHANES III indicate that the
average adolescent girl consumes only about 800 mg of calcium per
day, which is 400 mg less than the current recommended daily
allowance and 700 mg less than the amount recommended by the NIH
Consensus Conference on Optimal Calcium Intake in June 1994.
Moreover, a comparison between NHANES II (1976-80) and NHANES III
(1988-91) indicates a decline of about 100 milligrams in daily
calcium intake in male and female children 6-to-11 years old.
 
Results of the Teen Lifestyle Project showed that two-thirds of
adolescent girls are dieting and that 90% of white girls are
dissatisfied with their body image.  Their concerns about body weight
lead them to substitute low-calorie drinks for dairy products in
their diet.  When carried to extremes, dieting among adolescent girls
can lead to anorexia, amenorrhea, and osteopenia, a triad seen in
high performance athletes and dancers.  Although osteoporosis is more
common in women, about one-fifth of osteoporotic fractures occur in
men; and, occasionally men suffer from severe osteoporosis in middle
age.  Therefore, studies of the antecedents of osteoporosis should
not be limited to females.
 
Studies of calcium supplementation have indicated that a significant
increase in bone mineral density can be demonstrated in children and
adolescents given supplemental calcium.  It appears as if there may
be a narrow window of time during which calcium supplementation will
engender an increase in bone density.  In the setting of the
prevailing high-sodium, low-magnesium diet in the United States, it
also appears as if augmented calcium intake may be necessary to
maintain any increase in bone density attained during adolescence.
 
Research Scope
 
The objective of this RFA is to encourage and promote new and
innovative research to prevent the development of osteopenia and
osteoporosis by focusing on strategies applicable during childhood
and adolescence.  The following are examples of research topics that
are appropriate for this RFA; however, they are not to be considered
as exclusive or limiting:
 
o  Studies focused on calcium, magnesium, and sodium intake in
children and adolescents; the public health implications of
preventing osteoporosis; education and motivational research; and
exercise as a preventive measure.
 
o  Identifying children at high risk of developing osteoporosis later
in life.  Intervention could then be directed at especially
vulnerable children rather than attempting to increase calcium
consumption among all adolescents.  Intervention studies - especially
those testing alterations in calcium, sodium, magnesium, and vitamin
intake - are encouraged that target children and adolescents found to
be at high risk for osteoporosis later in life.
 
o  Exploring relationships between physical activity and bone mineral
acquisition and between bone mineral content and bone strength during
childhood and adolescence.
 
o  Elucidating genetic, physical, biochemical, and dietary markers to
identify those children and adolescents at highest risk of
osteoporosis later in life; and/or intervention studies of nutrition
and/or exercise in preventing osteopenia and osteoporosis.
 
o  Elucidating the interplay of genetic, hormonal, and environmental
factors influencing the assimilation of dietary calcium, the renal
excretion of calcium, and the incorporation of calcium into bone.  In
this regard the body's capacity to adapt to low dietary intake of
calcium is of particular interest; as are studies that address the
importance of ratios of minerals in the diet in this regard, e.g.,
calcium:magnesium and calcium:sodium.
 
o  Either animal trials or clinical studies may be submitted in
response to this RFA, but the limited funds available preclude
funding of any large-scale clinical trials.
 
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN
SUBJECTS
 
It is the policy of the NIH that women and members of minority groups
and their subpopulations must be included in all NIH supported
biomedical and behavioral research projects involving human subjects,
unless a clear and compelling rationale and justification are
provided that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research.  This policy results
from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
 
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 the NIH
GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number
11.
 
APPLICATION PROCEDURES
 
The research grant application form PHS 398 (rev.  5/95) is to be
used in applying for these grants.  Applications kits are available
at most institutional offices of sponsored research and may be
obtained from the Office of Extramural Outreach and Information
Resources, National Institutes of Health, 6701 Rockledge Drive, MSC
7910, Bethesda, MD 20892-7910, telephone 301/435-0714, E-mail:
asknih@odrockm1.od.nih.gov.
 
The RFA label available in the application form PHS 398 (rev. 5/95)
must be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title (PREVENTION OF OSTEOPOROSIS)
and number (HD-97-006) must be typed on line 2 of the face page of
the application and the YES box must be checked.
 
FIRST (R29) award applications must include at least three sealed
letters of reference attached to the face page of the original
application.  FIRST (R29) award applications submitted without the
required number of reference letters will be considered incomplete
and will be returned without review.
 
Submit a signed, typewritten original of the application, including
the Checklist, and three signed, exact photocopies, in one package
to:
 
DIVISION OF RESEARCH GRANTS
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, SUITE 1040, MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application
must also be sent to:
 
Susan Streufert, Ph.D.
Division of Scientific Review
National Institute of Child Health and Human Development 6100
Executive Boulevard, Room 5E01 - MSC 7510
Bethesda, MD  20892-7510
 
Applications prepared in response to this RFA must be received by
September 5, 1997.  If an application is received after that date, it
will be returned to the applicant without review.  The Division of
Research Grants (DRG) will not accept any application in response to
this RFA that is essentially the same as one pending initial review,
unless the applicant withdraws the pending application.  The DRG will
not accept any application that is essentially the same as one
already reviewed.  This does not preclude the submission of
substantial revisions of applications already reviewed, but such must
applications must include an introduction addressing the previous
critique.
 
REVIEW CONSIDERATIONS
 
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NICHD.  Incomplete or non-responsive
applications will be returned to the applicant without further
consideration.  Applications that are complete and responsive to the
RFA will be evaluated for scientific and technical merit by an
appropriate peer review group convened by the NICHD in accordance
with the review criteria stated below.  As part of the initial merit
review, a process may be used by the initial review group in which
applications will be determined to be competitive or non-competitive
based on their scientific merit relative to other applications
received in response to the RFA.  Applications judged to be
competitive will be discussed in depth and assigned a priority score.
Applications determined to be non-competitive will be withdrawn from
further consideration.  A summary statement will be prepared, and the
principal investigator and the official signing for the applicant
organization will be notified.
 
Review Criteria
 
The review criteria for the evaluation of applications are:
 
Significance: Does this study address an important problem?  If the
aims of the application are achieved, how will scientific knowledge
be advanced?  What will be the effect of these studies on the
concepts or methods that drive this field?
 
Approach: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project?  Does the applicant acknowledge potential problem areas
and consider alternative tactics?
 
Innovation: Does the project employ novel concepts, approaches or
method?  Are the aims original and innovative?  Does the project
challenge existing paradigms or develop new methodologies or
technologies?
 
Investigator: is the investigator appropriately trained and well
suited to carry out this work?  Is the work proposed appropriate to
the experience level of the principal investigator and other
researchers (if any)?
 
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success?  Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements?  Is there
evidence of institutional support?~
 
The initial review group will also examine: the adequacy of plans to
include both genders and minorities and their subgroups as
appropriate for the scientific goals of the research and plans for
the recruitment and retention of subjects; the provisions for the
protection of human and animal subjects; and the safety of the
research environment.
 
AWARD CRITERIA
 
Scientific merit and technical proficiency, as determined by peer
review, based on the demonstrated and projected capabilities
described in the application, will be the predominant criteria for
determining funding priorities.
 
Schedule
 
Application Receipt Date:    September 5, 1997
Review by Advisory Council:  January 1998
Anticipated Date of Award:   April 1, 1998
 
INQUIRIES
 
Written and telephone inquiries concerning this RFA are encouraged.
The opportunity to clarify any issues or questions from potential
applicants is welcomed.
 
Direct inquiries regarding programmatic issues to:
 
Gilman D. Grave, M.D.
Center for Research for Mothers and Children
National Institute of Child Health and Human Development 6100
Executive Boulevard, Room 4B11 - MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-5593
FAX:  (301) 480-9791
Email:  GRAVEG@HD01.NICHD.NIH.GOV
 
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, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  joan_mcgowan@nih.gov
 
Direct inquiries regarding fiscal matters to:
 
E. Douglas Shawver
Grants Management Branch
National Institute of Child Health and Human Development 6100
Executive Boulevard, Room 8A17 - MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
FAX:  (301) 402-0915
Email:  SHAWVERD@HD01.NIH.GOV
 
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, MD  20892-6500
Telephone:  (301) 594-3504
FAX:  (301) 480-4543
Email:  vicki_maurer@nih.gov
 
AUTHORITY AND REGULATIONS
 
This program is described in the Catalog of Federal Domestic
Assistance No. 93.865, Research for Mothers and Children and Catalog
of Federal Domestic Assistance No. 93.846, Arthritis, Musculoskeletal
and Skin Research.  Awards are made under the authority 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 Part 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.
 
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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