Bone Health Table 5 Treatment Studies using Pharmacology for Bone Health after a Spinal Cord Injury

Author Year; Country
Score
Research Design
Total Sample Size

Methods

Outcome

Bauman et al. 2005b;
USA
PEDro=10
RCT
N=40

Population: 40 subjects with complete motor injuries; 17 participants with tetraplegia and 23 participants with paraplegia.
Treatment: Vitamin D analog, 24 months.
1. Vitamin D: 4μg 1-alpha D(2) (n=19);
2. Placebo (n=21) was administered daily for 24 months; or
3. Both groups received calcium and vitamin D.
Outcome measures: BMD by DXA, biomarkers at 6, 12, 18, and 24 months.

  1. Significant changes noted in leg BMD only in the vitamin D group at 6, 12, 18, and 24 months.  There was significant interaction for group by time.
  2. In the vitamin D group, smoking had a negative effect on increase in percent change of BMD.
  3. In the vitamin D group, urinary marker of bone resorption was significantly reduced, but markers of bone formation were not changed.

Zehnder et al. 2004; Switzerland
PEDro=7
RCT
N=65

Population: 65 men, ages 18-60, participants had complete injuries between T1-L3, with a diagnosis of AIS A or B.
Treatment: Alendronate for 24 months. 1.10mg per day plus 500mg calcium per day (N=33) or
2. calcium alone (500mg per day) (N=32).
Outcome measures: BMD byDXA and bone turnover markers.

  1. Decrease in BMD of the tibia in calcium group but remained stable in the Treatment group (group difference, p = 0.017). There was no change in wrist BMD and a significant increase in lumbar spine BMD in both groups.  BMD of the mid-shaft tibia and hip were maintained in the Treatment group and decreased in the calcium group.
  2. Biochemical markers of bone absorption significantly decreased from baseline in the Treatment group.

Moran de Brioto et al. 2005; Brazil
PEDro=6
RCT
N=19

Population: 19 men (< 50 yrs) and women (< 35 yrs), with paraplegia or tetraplegia, AIS: A, B, or C.
Treatment: Alendronate for 6 months.
1. 10mg and calcium 1000 mg bid (N=10) and
2. calcium (1000 mg bid) (N=9).
Outcome measures: BMD by DXA

  1. There was a mean increase in upper extremity BMD that was greater in Treatment vs. calcium group although not statistically significant. There were significant differences for total T-index and BMD.