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CompletedNCT00472745Updated May 13, 2026

The Effect of Weight Loss on Bone in Men

An interventional study of Weight Loss and Weight Maintenance in Weight Loss and BMD, sponsored by Rutgers University. Completed at 1 site in United States. Open to male participants aged 50 Years to 72 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by Rutgers University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Non-randomized
Ages
50 Years to 72 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Weight Loss
  • BMD

Keywords

  • bone mass
  • calcium absorption
  • bone quality
  • fracture risk
  • arthritis
  • osteoporosis
03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 44 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

Rutgers University is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 72 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    WL

    weight loss (WL) with nutrition/behavior modification counseling

    Behavioral: Weight Loss

  • Active comparator
    WM

    Weight Maintenance (WM)

    Behavioral: Weight Maintenance

Interventions

  • BehavioralWeight 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

  • BehavioralWeight Maintenance

    Diet for weight maintenance for 6 months

06

What researchers measure

Primary outcomes

  1. Changes in bone density and quality

    Time frame: 6 months

07

Study locations

1 site
  • Rutgers University
    New Brunswick, New Jersey 08901, United States
08

References and documents

Publications

  • Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. doi: 10.1093/jn/136.6.1453. PubMed 16702302 ↗
  • Riedt CS, Cifuentes M, Stahl T, Chowdhury HA, Schlussel Y, Shapses SA. Overweight postmenopausal women lose bone with moderate weight reduction and 1 g/day calcium intake. J Bone Miner Res. 2005 Mar;20(3):455-63. doi: 10.1359/JBMR.041132. Epub 2004 Nov 29. PubMed 15746990 ↗
  • Cifuentes M, Riedt CS, Brolin RE, Field MP, Sherrell RM, Shapses SA. Weight loss and calcium intake influence calcium absorption in overweight postmenopausal women. Am J Clin Nutr. 2004 Jul;80(1):123-30. doi: 10.1093/ajcn/80.1.123. PubMed 15213038 ↗
  • Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. doi: 10.1038/oby.2004.7. PubMed 14742841 ↗
  • Pop LC, Sukumar D, Tomaino K, Schlussel Y, Schneider SH, Gordon CL, Wang X, Shapses SA. Moderate weight loss in obese and overweight men preserves bone quality. Am J Clin Nutr. 2015 Mar;101(3):659-67. doi: 10.3945/ajcn.114.088534. Epub 2015 Jan 7. PubMed 25733651 ↗
  • Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11. PubMed 35538903 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00472745
Lead sponsor
Rutgers University
Collaborators
National Institute on Aging (NIA)
Responsible party
Sue A. Shapses, Ph.D., RD (Professor, Rutgers University) — Principal investigator
First posted
May 14, 2007
Start date
Mar 2007
Primary completion
Apr 2012
Completion
Apr 2012
Last update
May 13, 2026

Study contacts

Sue Shapses, PhD, RD
principal investigator · Rutgers University, Nutritional Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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