Status:
COMPLETED
Low Magnitude Mechanical Stimuli Effects on Bone Structure in ESRD
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Renal Osteodystrophy
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief 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 dail...
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 met...
Eligibility Criteria
Inclusion
- ages 21-65 years
- Maintenance Hemodialysis
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00364234
Start Date
May 1 2006
End Date
September 1 2007
Last Update
April 14 2015
Active Locations (1)
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1
Childen's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104