The Effect of Weight Loss on Bone in Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00472745
Recruitment Status : Completed
First Posted : May 14, 2007
Last Update Posted : July 15, 2014
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Sue Shapses, Rutgers University

Brief Summary:
The purpose of this study is to determine the effect of weight loss on bone health in men.

Condition or disease Intervention/treatment Phase
Weight Loss BMD Behavioral: Weight Loss Behavioral: Weight Maintenance Not Applicable

Detailed Description:

This pilot study of the effect of weight loss on bone health in men is being undertaken in conjunction with studies of the effect of weight loss on bone health in women for comparison purposes. See NCT00473031, NCT00472680, and NCT00472654. This information is important for determining optimal nutrient requirements during weight loss.

Participants will be recruited for both weight loss and weight maintenance. All participants will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Weight loss participants will attend regular counseling sessions (about 45 minutes each) with a dietitian for approximately 6 months; they will be asked to attend 6 sessions but will be given the opportunity to attend 13 sessions. Body composition will be measured by a dual-energy x-ray absorptiometry (DXA) machine, ultrasound, and peripheral quantitative computer tomography (pQCT) before and after 6 months of weight loss. Bone, mineral, protein and lipid markers, and hormones that influence bones will also be measured.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nutritional Regulation of Bone - Pilot Study
Study Start Date : March 2007
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: WL
weight loss (WL) with nutrition/behavior modification counseling
Behavioral: Weight Loss
Weight loss participants will consume a reduced calorie diet based on their individual caloric needs to lose 1.5-2 lbs/week, and will attend regular counseling sessions (for about 45 minutes each) with a dietitian for 6 months
Active Comparator: WM
Weight Maintenance (WM)
Behavioral: Weight Maintenance
Diet for weight maintenance for 6 months

Primary Outcome Measures :
  1. Changes in bone density and quality [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Obese or overweight
  • Must live in the geographic vicinity of Rutgers University

Exclusion Criteria:

  • Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease [i.e., heart attack or stroke in the past 6 months., abnormal EKG], active malignancy or cancer therapy within the past year)
  • History of kidney stones
  • Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
  • Participation in other investigational studies during the 12-month study period
  • Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00472745

United States, New Jersey
Rutgers University
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers University
National Institute on Aging (NIA)
Principal Investigator: Sue Shapses, PhD, RD Rutgers University, Nutritional Sciences

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sue Shapses, Professor, Rutgers University Identifier: NCT00472745     History of Changes
Other Study ID Numbers: AG0084
5R01AG012161 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2007    Key Record Dates
Last Update Posted: July 15, 2014
Last Verified: December 2012

Keywords provided by Sue Shapses, Rutgers University:
bone mass
calcium absorption
bone quality
fracture risk

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms