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: July 12, 2014
Last verified: December 2012
  Purpose

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


Condition Intervention
Weight Loss
BMD
Behavioral: Weight Loss
Behavioral: Weight Maintenance

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nutritional Regulation of Bone - Pilot Study

Resource links provided by NLM:


Further study details as provided by Rutgers University:

Primary Outcome Measures:
  • Changes in bone density and quality [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: March 2007
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 72 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472745

Locations
United States, New Jersey
Rutgers University
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Sue Shapses, PhD, RD Rutgers University, Nutritional Sciences
  More Information

Publications:
Responsible Party: Sue Shapses, Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT00472745     History of Changes
Other Study ID Numbers: AG0084, 5R01AG012161
Study First Received: May 10, 2007
Last Updated: July 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Rutgers University:
bone mass
calcium absorption
bone quality
fracture risk
arthritis
osteoporosis

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

ClinicalTrials.gov processed this record on August 28, 2014