Bone DiseasesNCT00270608
How Does Early Age Life Style Affect Bone Strength and General Health Parameters at Middle Age?
An observational study of Bone Diseases, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the effect of vigorous physical activity versus extremely sedentary life style during young age on the bone mineral density and general health in later life. Read more about this study
- Who is it for?
- Ages 40 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Diseases
- What is being tested?
- Quantitative Computed Tomography of the tibia and spine, MRI of the spine and the right knee and Blood test
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2007to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Israeli males who were 17-22 years-old and received a military profile of either 82 or 97 in 1983
Who may be able to join
- Israeli military profile 82 or 97 at age 17-22
Who cannot join
- Israeli military profile less than 82 at age 17-22
- Former soldiers with shrapnel injuries will be excluded from MRI studies
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: How Does Early Age Life Style Affect Bone Strength and General Health at Middle Age? Twenty-Five Year Follow-up Health Status Comparison of a Sedentary Versus Extremely Physically Active Population From an Early Age
The purpose of this study is to evaluate the effect of vigorous physical activity versus extremely sedentary life style during young age on the bone mineral density and general health in later life.
Read the detailed description
Bone strength and peak bone mass are preliminary determined by genetic factors. Life style, especially exercise, is also considered to have an important effect on bone strength. Bone has the ability to strengthen itself according to Wolff's Law. When bone is subjected to strains and/or strain rates higher than the usual, it responds by remodeling, strengthening its architecture. The ability is greatest in young individuals and decreases with age. In the elderly this ability is largely non-existent and bone mass is lost. Whether this loss leads to osteoporosis is largely a function of the peak bone mass achieved before the decline. 11% of males and 44 % of females over 50 suffer from osteoporosis in later life. To what extent vigorous exercising beginning at a young age can increase bone strength is not known.
The purpose of the proposed research is to quantify the effect of life style on bone strength and general health parameters by comparing two male populations, one sedentary and the other that has done demanding physical training: (1) Elite infantry recruits who were inducted into the I.D.F. in Feb 1983, did their basic training at Sanur and were part of the 1983 stress fracture project who completed three years of elite infantry service and continued to serve as combat soldiers in the reserves; (2) Yeshiva students who had profiles of 82 or 97 and received deferment from their military service in 1983 and since then have continued their studies and never served in the army.
50 subjects will be reviewed in each group. Measurements of weight, height, waist and abdominal girth, resting pulse and blood pressure will be made. The brachial/ankle blood pressure index will be recorded. MRI of the right knee to study potential degenerate changes will be done using a 1.5 Tesla General Electric Signa MR scanner. Quantitative Computed Tomography (QCT), one of the most popular and effective methods utilized for osteoporosis screening, will be performed to determine volumetric BMD, BMC, bone geometric properties and strength indexes of the tibia and lumbar spine.
Comparisons:
Group I: 50 males (age 41-45), former elite Israeli infantry soldiers, selected randomly from those recruits who did their infantry basic training at Sanur in Feb. 1983 (all profiled 82 or 97) and completed their military service as combat soldiers will be compared to:
Group II: 50 age-, profile- and ethnically-matched Israeli citizens whose military service was deferred in 1983 because of Torah studies and who did not do army service and were not involved in any kind of physical training.
- Conditions
- Bone Diseases
- Being tested
- Quantitative Computed Tomography of the tibia and spine, MRI of the spine and the right knee, Blood test
- Keywords
- Hypertension, Peripheral vascular disease, Diabetes, Total body fat percentage
- Medical subject headings
- Bone Diseases, Hypertension, Peripheral Vascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Computed Tomography of the tibia and spineProcedure or surgery
a single time 1 minute procedure
MRI of the spine and the right kneeProcedure or surgery
a single time 45 minutes procedure
Blood testProcedure or surgery
A single time procedure to check lipid profile and hemoglobin A1C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startMar 2007
- Study completionNov 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Prof. Charles Milgrom, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270608
- Sponsor's protocol ID
- 12-17.02.06-HMO-CTIL
- Status last verified
- Nov 2007
- First submitted
- 26 Dec 2005
- Last updated
- 27 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Milgrom C, Giladi M, Stein M, Kashtan H, Margulies JY, Chisin R, Steinberg R, Aharonson Z. Stress fractures in military recruits. A prospective study showing an unusually high incidence. J Bone Joint Surg Br. 1985 Nov;67(5):732-5. doi: 10.1302/0301-620X.67B5.4055871.
PubMed 4055871
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Early Age Life Style Affect Bone Strength and General Health at Middle Age? Twenty-Five Year Follow-up Health Status Comparison of a Sedentary Versus Extremely Physically Active Population From an Early Age
- ClinicalTrials.gov ID
- NCT00270608
- Acronym / sponsor ID
- 12-17.02.06-HMO-CTIL
- Conditions
- Bone Diseases
- Keywords
- Hypertension, Peripheral vascular disease, Diabetes, Total body fat percentage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Nov 2008 (estimated)
- First posted
- 28 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of vigorous physical activity versus extremely sedentary life style during young age on the bone mineral density and general health in later life.
Detailed description
Bone strength and peak bone mass are preliminary determined by genetic factors. Life style, especially exercise, is also considered to have an important effect on bone strength. Bone has the ability to strengthen itself according to Wolff's Law. When bone is subjected to strains and/or strain rates higher than the usual, it responds by remodeling, strengthening its architecture. The ability is greatest in young individuals and decreases with age. In the elderly this ability is largely non-existent and bone mass is lost. Whether this loss leads to osteoporosis is largely a function of the peak bone mass achieved before the decline. 11% of males and 44 % of females over 50 suffer from osteoporosis in later life. To what extent vigorous exercising beginning at a young age can increase bone strength is not known.
The purpose of the proposed research is to quantify the effect of life style on bone strength and general health parameters by comparing two male populations, one sedentary and the other that has done demanding physical training: (1) Elite infantry recruits who were inducted into the I.D.F. in Feb 1983, did their basic training at Sanur and were part of the 1983 stress fracture project who completed three years of elite infantry service and continued to serve as combat soldiers in the reserves; (2) Yeshiva students who had profiles of 82 or 97 and received deferment from their military service in 1983 and since then have continued their studies and never served in the army.
50 subjects will be reviewed in each group. Measurements of weight, height, waist and abdominal girth, resting pulse and blood pressure will be made. The brachial/ankle blood pressure index will be recorded. MRI of the right knee to study potential degenerate changes will be done using a 1.5 Tesla General Electric Signa MR scanner. Quantitative Computed Tomography (QCT), one of the most popular and effective methods utilized for osteoporosis screening, will be performed to determine volumetric BMD, BMC, bone geometric properties and strength indexes of the tibia and lumbar spine.
Comparisons:
Group I: 50 males (age 41-45), former elite Israeli infantry soldiers, selected randomly from those recruits who did their infantry basic training at Sanur in Feb. 1983 (all profiled 82 or 97) and completed their military service as combat soldiers will be compared to:
Group II: 50 age-, profile- and ethnically-matched Israeli citizens whose military service was deferred in 1983 because of Torah studies and who did not do army service and were not involved in any kind of physical training.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Israeli males who were 17-22 years-old and received a military profile of either 82 or 97 in 1983
Key inclusion criteria (1 listed)
- Israeli military profile 82 or 97 at age 17-22
Key exclusion criteria (2 listed)
- Israeli military profile less than 82 at age 17-22
- Former soldiers with shrapnel injuries will be excluded from MRI studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Computed Tomography of the tibia and spinea single time 1 minute procedure | Procedure or surgery | – |
| MRI of the spine and the right kneea single time 45 minutes procedure | Procedure or surgery | – |
| Blood testA single time procedure to check lipid profile and hemoglobin A1C | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2007.
- Results publication: PubMed 4055871Milgrom C, Giladi M, Stein M, Kashtan H, Margulies JY, Chisin R, Steinberg R, Aharonson Z. Stress fractures in military recruits. A prospective study showing an unusually high incidence. J Bone Joint Surg Br. 1985 Nov;67(5):732-5. doi: 10.1302/0301-620X.67B5.4055871.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Charles Milgrom, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Diseases, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof. Charles Milgrom, MD (972 50 787 4401, charles.milgrom@ekmd.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00270608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2007.