Low Magnitude Mechanical Stimuli Effects on Bone Structure in ESRD

Completed · Not applicable

Conditions studied: Renal Osteodystrophy

In brief

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.

Key facts

Study ID

NCT00364234

Run by

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

People needed

30

Starts

2006-05-01

Expected to finish

2007-09-01

Last updated by the study team

2015-04-14

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ages 21-65 years
• Maintenance Hemodialysis

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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