Bone Health Table 14: Studies of Bone Health Interventions with Biomarker Outcomes

Author Year; Country
Score
Research Design
Total Sample Size

Methods

Outcome

Chen et al. 2001;

USA

Case series

N = 21

Population: 21 adults (17 men) with acute SCI (6 to 122 days post-injury, median 26 days post-injury), mean age 34 years; AIS A (n = 17), AIS B (n = 2), AIS C or D (n = 2)

Treatment: 0.5 µg calcitriol daily x 6 days; 1250 mg calcium carbonate BID x 6 days; 30 mg pamidronate IV daily x 3 days (administered on days 4, 5, and 6 of study)

Outcome measures: Within 2 weeks prior to baseline, and again within 2 weeks following study completion:24-hour urine calcium and creatinine; spot urine NTx; serum calcium, phosphorus, intact PTH, 25-D, 1,25-D.

  1. Calcitriol-pamidronate therapy decreased urinary NTx excretion by 71% (p < 0.001), and urinary calcium excretion by 73% (p < 0.001).
  2. Calcitriol-pamidronate therpay increased serum PTH (p < 0.05) and 1,25-D (p < 0.005).
  3. Post-therapy hypocalcemia or hypophosphatemia occurred in 44% (p < 0.01) and 53% (p < 0.01) of participants, respectively.

Mechanick et al. 2006;

USA

Case series

N = 32

Population: 32 adults (25 men) with acute traumatic SCI; mean age 42 yrs; paraplegia (n=8), tetraplegia (n=13), AIS A (n=22), AIS B (n=5), AIS C (n=5).

Treatment: calcium 1000 mg daily and calcitriol 0.25 µg daily x 17 days, pamidronate 90 mg IV on day 4

Outcome measures: Serum calcium, phosphorus, and albumin; urinary calcium and NTx, serum intact PTH, 25-D, 1,25-D

  1. Single-dose calcitriol-pamidronate therapy decreased urinary NTx excretion by 64% (p<0.001) and urinary calcium excretion by 50% (p<0.002) in acute SCI.
  2. Post-therapy hypocalcemia or hypophosphalemia occurred in 75% (p<0.02) and 22% (p<0.02) of participants, respectively.
  3. Single-dose pamidronate is associated with increased incidence of fever (78%) compared to 30 mg daily x 3 days dosing regimen (20%).

Bauman et al. 2009;

USA

Case series

N = 8

 

Population: 8 men with chronic SCI (12 ± 8 yrs post-injury) and low vitamin D (25[OH]D ≤ 20 ng/mL) and/or elevated serum PTH (>55 pg/mL) , age 34 ± 7 yrs; paraplegia (n=6), tetraplegia (n=2)

Treatment: Calcium gluconate bolus (0.025 mmol elemental calcium/kg) over 20 min followed by calcium gluconate infusion (0.025 mmol/kg/hr) for 6 hrs.

Outcome measures: Serum total calcium, creatinine, NTx, and PTH at baseline, 2, 4, and 6 hrs post-infusion.

  1. At 2 hr time point, PTH dropped from 70 ± 25 pg/mL to 18 ± 12 pg/mL, and NTx dropped from 21 ± 8 nM bone collagen equivalent (BCE) to 17 ± 5 nM BCE.
  2. Calcium gluconate infusion reduced bone collagen catabolism during calcium infusion.
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