Low Magnitude Mechanical Stimuli Effects on Bone Structure in ESRD

NCT00364234 | Completed

• 2 other identifiers: R21 DK74105 (completed)R21DK074105
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Renal Osteodystrophy

Keywords

Renal Osteodystrophy

Outcome Measures

Primary Outcomes (1)

• Trabecular Microarchitecture

  6 months

Interventions

Low magnitude mechanical stimuli DEVICE

20 minutes standing on low magnitude high frequency vibrating platform

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Childen's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary B Leonard, MD, MSCE

  Children's Hospital of Philadelphia , Philadelphia, Pennsylvania, United States

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 14, 2006
• First Posted: August 15, 2006
• Study Start: May 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 14, 2015

Record last verified: 2015-04

Locations

US (1)