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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Prof. Charles Milgrom, MD contact

972 50 787 4401

charles.milgrom@ekmd.huji.ac.il

Israel1 site, 1 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

    Recruiting

Other trials in Israel

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.

  1. First posted28 Dec 2005 (estimated)
  2. Study startMar 2007
  3. Study completionNov 2008 (estimated)

Resources

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)
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

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.

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