The Effect of Weight Loss on Bone in Men

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sue Shapses, Rutgers University
ClinicalTrials.gov Identifier:
NCT00472745
First received: May 10, 2007
Last updated: December 16, 2012
Last verified: December 2012

May 10, 2007
December 16, 2012
March 2007
April 2012   (final data collection date for primary outcome measure)
Changes in bone density and quality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Changes in bone density and quality [ Time Frame: 6 months ]
Complete list of historical versions of study NCT00472745 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Weight Loss on Bone in Men
Nutritional Regulation of Bone - Pilot Study

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Weight Loss
  • BMD
  • 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
  • Behavioral: Weight Maintenance
    Diet for weight maintenance for 6 months
  • Experimental: WL
    weight loss (WL) with nutrition/behavior modification counseling
    Intervention: Behavioral: Weight Loss
  • Active Comparator: WM
    Weight Maintenance (WM)
    Intervention: Behavioral: Weight Maintenance

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
April 2012
April 2012   (final data collection date for primary outcome measure)

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)
Male
50 Years to 72 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00472745
AG0084, 5R01AG012161
Yes
Sue Shapses, Rutgers University
Rutgers University
National Institute on Aging (NIA)
Principal Investigator: Sue Shapses, PhD, RD Rutgers University, Nutritional Sciences
Rutgers University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP