Low Magnitude Mechanical Stimuli Effects on Bone Structure in ESRD

April 13, 2015 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Low Magnitute Mechanical Stimuli Effects on Bone Structure in ESRD

The proposed 6 month pilot and feasibility randomized trial will evaluate LMMS as an anabolic stimulus to bone in 30 adults on maintenance hemodialysis. The intervention will consist of 20 minute daily sessions in the home standing on an active LMMS platform or a placebo device that emits an audible hum suggestive of an active device. Each device contains an electronic monitor that documents adherence. The study will examine trabecular bone volume fraction (bone volume/total volume, BV/TV %) and architecture using microMRI, and cortical volumetric BMD and dimensions using QCT at baseline and 6 months. The hypothesis is that active LMMS will results in greater mean changes in trabecular and cortical parameters in hemodialysis patients. The proposed study will test the feasibility of conducting the intervention in dialysis patients and will generate preliminary data on rates of change in trabecular and cortical parameters in the active and placebo groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Renal osteodystrophy (ROD) is a multifactorial and pervasive disorder in chronic kidney disease (CKD). As renal failure progresses, ensuing abnormal parathyroid hormone (PTH) secretion and mineral metabolism result in sclerosis of trabecular bone, thinning of cortical bone, and increased cortical porosity.(1) Despite the widespread use of phosphate binders and vitamin D therapies, hip fracture rates and mortality risk following fractures are markedly greater in dialysis patients, compared with the general population.

The vast majority of studies of bone loss in CKD relied on dual energy x-ray absorptiometry (DXA) measures of bone mineral density (BMD). However, DXA summarizes the total bone mass within the projected bone area, concealing disease effects on trabecular and cortical bone. For example, in high-turnover ROD, increased trabecular volume may offset cortical bone loss, resulting in normal or increased areal-BMD despite poor bone strength. Quantitative computed tomography (QCT) enables discrete assessment of trabecular and cortical volumetric BMD and dimensions. However, this is an incomplete solution in the setting of CKD because QCT does not assess trabecular architecture. Micro-magnetic resonance imaging (µMRI) provides a non-invasive technique to assess trabecular architecture. The µMRI data are quantified by 3D digital processing methods, such as topological analysis, to determine trabecular properties. Our pilot study of µMRI in dialysis patients revealed significant reductions in cortical thickness and suggested deterioration in the trabecular network. This innovative imaging modality may be uniquely suited to the assessment of ROD therapies.

Mechanical forces on the skeleton arise from muscle contraction and these forces generate signals that modulate bone architecture. Animal studies demonstrated that daily exposure to low magnitude mechanical stimuli (LMMS) enhanced trabecular and cortical bone quantity and quality. A randomized trial of LMMS in post-menopausal women demonstrated that LMMS were associated with increased DXA BMD, without adverse effects. LMMS may be uniquely suited to restore cortical and trabecular bone structure in ROD.

The study will enroll adults, ages 21-65 years, treated with maintenance hemodialysis at UPENN. The study will exclude the elderly and subjects with major co-morbid conditions in order to increase the likelihood that subjects will complete the 6 month intervention without significant interruptions due to hospitalization.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Childen's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ages 21-65 years
  • Maintenance Hemodialysis

Exclusion Criteria:

  • Active Malignancy
  • History of myocardial infarction
  • Congestive heart failure III-IV stage
  • Cerebrovascular disease
  • Planned relocation
  • Pregnancy
  • Anticipated living-donor transplantation within the coming 6 months
  • Liver failure
  • Neuropathies
  • Prior lower extremity amputation or difficult with ambulation
  • History of hip fracture
  • History of hip replacement
  • History of orthostatic hypotension or a balance disorder
  • History of a fall within 6 months prior to enrollment
  • Difficulty in ambulation will be defined as difficulty climbing two flights of stairs or walking three blocks
  • Patients with pacemaker or other metal implants that are contraindicated for MRI scans
  • Weight > 113kg
  • HIV Positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Trabecular Microarchitecture
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Mary B Leonard, MD, MSCE, Children's Hospital of Philadelphia , Philadelphia, Pennsylvania, United States

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

August 14, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (Estimate)

August 15, 2006

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21 DK74105 (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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