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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00364234
Other study ID # R21 DK74105 (completed)
Secondary ID
Status Completed
Phase N/A
First received August 14, 2006
Last updated April 13, 2015
Start date May 2006
Est. completion date September 2007

Study information

Verified date April 2015
Source National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Low magnitude mechanical stimuli
20 minutes standing on low magnitude high frequency vibrating platform

Locations

Country Name City State
United States Childen's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trabecular Microarchitecture 6 months No
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