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Trial record 8 of 20 for:    "Osteogenesis imperfecta"
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Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta

This study is currently recruiting participants.
Verified October 2012 by Shriners Hospitals for Children
Sponsor:
Information provided by (Responsible Party):
Louis-Nicolas Veilleux Ph.D., Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT01713231
First received: October 21, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose
  • Overall Objective: To test the hypothesis that oral vitamin D supplementation at higher than currently prescribed doses has a beneficial effect on the skeleton of young patients with osteogenesis imperfecta (OI).
  • Specific Aims: 1. To determine whether 12 months of high-dose vitamin D supplementation, compared to standard-dose vitamin D supplementation, increases areal bone mineral density z-scores at the lumbar spine. 2. To examine the effectiveness of high-dose vitamin D supplementation to increase trabecular and cortical bone mineral density at the radius. 3. To examine whether high-dose vitamin D supplementation has an effect on physiological determinants of bone mass (parathyroid hormone, activity of bone metabolism, muscle function).
  • Background: In a preliminary cross-sectional study of 282 OI patients we observed an inverse relationship between serum 25-hydroxyvitamin D and parathyroid hormone levels and a positive relationship between circulating levels of 25-hydroxyvitamin D and lumbar spine areal bone mineral density z-scores. This suggested that high-dose vitamin D supplementation would have a beneficial effect on bone density. Most OI patients currently receive oral vitamin D supplementation of 400 International Units per day, but doses of 2000 International Units per day are safe and have been shown to be beneficial in studies on healthy adolescents.
  • Study Design: This is a parallel-group double-blind randomized controlled trial of 12 months duration on 60 children and adolescents aged 6 to 19 years with a clinical diagnosis of OI. One group of 30 participants will be randomized to receive vitamin D3 at a dose of 2000 international units per day ('high-dose group'). The other group of 30 participants will be randomized to receive vitamin D3 at a dose of 400 international units per day ('standard-dose group'). Randomization will be stratified according to pubertal status and bisphosphonate treatment status.
  • Clinical Relevance: The proposed study aims at direct improvements in the care of OI patients. If a simple and low-cost 'intervention' such as high-dose vitamin D supplementation can be shown to be effective in relieving some of the disease burden associated with OI, the benefit to OI patients worldwide would be substantial.

Condition Intervention Phase
Osteogenesis Imperfecta
 Dietary Supplement: standard-dose vitamin D (400IU per day)
Dietary Supplement: high-dose vitamin D (2000 IU per day)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of High-Dose Vitamin D on Bone Density in Osteogenesis Imperfecta

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • Change in areal bone mineral density z-score of the lumbar spine [ Time Frame: at baseline and 12 months ] [ Designated as safety issue: No ]
    LS-aBMD z-score will be used as the primary outcome.The lumbar spine is the standard site of measurement both in the clinical follow up of OI patients .


Secondary Outcome Measures:
  • Change in trabecular and cortical volumetric bone mineral density z-scores at the radius, as measured by pQCT, relative to baseline. [ Time Frame: at baseline and at 12 months ] [ Designated as safety issue: No ]
    Trabecular bone is analyzed at the distal radial metaphysis ('4% site'). Cortical bone is analyzed at the radial diaphysis ('65% site').


Other Outcome Measures:
  • Percentage change in lower extremity muscle power per body weight, as measured by jumping mechanography, relative to baseline. [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    A countermovement jump to maximal height ('single two-legged jump') will be evaluated. In patients who are unable to jump, the heel-rise test will be used to determine muscle power.


Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard-dose vitamin D
one group of 30 participants will be randomized to receive vitamin D3 at a dose of 400 international units per day ('standard-dose group').
 Dietary Supplement: standard-dose vitamin D (400IU per day)
Experimental: high-dose vitamin D
One group of 30 participants will be randomized to receive vitamin D3 at a dose of 2000 international units per day ('high-dose group').
 Dietary Supplement: high-dose vitamin D (2000 IU per day)

  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of OI of any type.

Exclusion Criteria:

  • Any condition that renders bone density measurements at the lumbar spine impossible. An example for this is prior spinal fusion surgery.
  • Bisphosphonate therapy for less than two years duration.
  • Use of medication, other than bisphosphonates, known to affect bone metabolism or 25OHD serum concentrations. Examples are anti-epileptics, active vitamin D metabolites, corticosteroids and thyroid hormones.
  • Liver and renal disease known to interfere with vitamin D metabolism.
  • Any other disorder of calcium and phosphate metabolism (apart from vitamin D deficiency) that might interfere with PTH.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713231

Contacts
Contact: Louis-Nicolas Veilleux, PhD +1 514 2827175 lnveilleux@shriners.mcgill.ca
Contact: Laura Plante, MSc +1 514 2827158 laura.plante@mail.mcgill.ca

Locations
Canada, Quebec
Shriners Hospitals for Children-Canada Recruiting
Montréal, Quebec, Canada, H3G1A6
Contact: Marie-Josée Giguère, MSc     +1 514 2828249     mjgiguere@shriners.mcgill.ca    
Contact: Louis-Nicolas Veilleux, PhD     +1 514 2827175     lnveilleux@shriners.mcgill.ca    
Principal Investigator: Frank Rauch, MD            
Sponsors and Collaborators
Louis-Nicolas Veilleux Ph.D.
  More Information

No publications provided

Responsible Party: Louis-Nicolas Veilleux Ph.D., postdoctoral fellow, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT01713231     History of Changes
Other Study ID Numbers: A02-M14-12A
Study First Received: October 21, 2012
Last Updated: October 21, 2012
Health Authority: Canada: Health Canada

Keywords provided by Shriners Hospitals for Children:
osteogenesis imperfecta
high-dose vitamin D
bone density
muscle function

Additional relevant MeSH terms:
Osteogenesis Imperfecta
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
 Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 13, 2013