Vitamin D supplementation for bone mineral density increase in osteogenesis imperfecta

Study Type: Randomized Trial
OE Level of Evidence: 2
Journal Level of Evidence: N/A
Synopsis
60 youth and adolescent patients with osteogenesis imperfecta (OI) were randomized to either high-dose vitamin D supplementation (2000IU daily) or low-dose vitamin D supplementation (400IU daily). The purpose of this study was to evaluate if high-dose supplementation led to a significant increase in areal bone mineral density (aBMD) z-score of the lumbar spine compared to low-dose supplementation over 1 year. Overall, there was Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Non-Industry funded
Sponsor: the Shriners of NorthAmerica, theNetwork for Oral and Health Bone Research as well as the Fonds de Recherche du Québec — Santé
Conflicts: None disclosed
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Why was this study needed now?
Osteogenesis imperfecta is a congenital bone disease characterized by decreased bone mineral density, bone malformation, and increased risk of fracture among youth and adolescents. As there is no cure, current management aims to increase bone mineral density among affected individuals. Vitamin D supplementation has been implicated as a possible effective management strategy, as many youths with OI present with low serum 25-hydroxyvitamin D concentrations. Nonetheless, suggestions of the efficacy of vitamin D supplementation have predominantly stemmed from low-quality evidence, with a clear need for a randomized controlled trial.
What was the principal research question?
In youths and adolescents with osteogenesis imperfecta, does high-dose vitamin D supplementation significantly increase areal bone mineral density z-score of the lumbar spine when compared to low-dose vitamin D supplementation, assessed over 1-year follow-up?
Population: 60 patients, 6-19 years of age, with osteogenesis imperfecta. Eligibility criteria also indicated that patients either have not received bisphosphonate therapy or had been on bisphosphonate therapy for more than 2 years.
Intervention: 2000IU vitD group: Patients were prescribed 2000IU of vitamin D daily (two 1000IU pills per day) for 1 year. (n=30 randomized; 28 analyzed) (Mean age: 11.6 +/- 3.3; 16M/14F)
Comparison: 400IU vitD group: Patients were prescribed 400IU of vitamin D daily (one placebo pill, one 400IU pill) for 1 year. (n=30; 28 analyzed) (Mean age: 11.7 +/- 3.3; 9M/21F).
Outcomes: Anteroposterior dual energy x-ray absorptiometry was used to assess areal bone mineral density (aBMD) of the lumbar spine, and converted into age- and sex-specific z-score (primary outcome). Peripheral quantitative computed tomography (pQCT) was also performed to assess cortical and trabecular volumetric bone mineral density (vBMD) of the distal radius, and as well converted into z-score (secondary outcome). Lower-body power was assessed using a single-two legged jump test and heel rise test with patients on a group reaction force plate (secondary outcome). Serum analysis was performed, measuring concentrations of 25-hydroxyvitamin D, procollagen type I N-terminal propeptide, collagen type I C-telopeptide, parathyroid hormone, calcium, phosphorus, and alkaline phosphatase. Dietary intake was assessed to measure total intake of vitamin D. Treatment compliance was measured by counting remaining pills at the end of the treatment phase.
Methods: RCT; participant and assessor blind
Time: Follow-up scheduled for 12 months.
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.