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Combination Interventions

As this chapter goes to press, the first generation of studies of combination interventions for the treatment of BMD decline in chronic SCI are being completed. These studies evaluate the concurrent administration of pharmacological therapy with non-pharmacological rehabilitation interventions. Some examples of registered trials include studies of zoledronate in combination with FES-rowing and recombinant PTH (Forteo) in combination with weight-bearing. Table 17 describes the early results from one such trial.

Table 17: Combined Interventions for Treatment of Bone

Author Year; Country
Score
Research Design
Total Sample Size
MethodsOutcome
Gordon et al. 2013

USA

Pre-post

Level 4

N=12

Population: 12 nonambulatory participants (10 men, 2 women) with chronic SCI; age: 34 ± 8 years; TPI: 7.7 years; 5 AIS A, 3 AIS B, 4 AIS C; low total hip bone mass (DXA T-score < 2.5 or Z-score < 1.5); C1-T10.

Treatment: teriparatide (PTH 1-34) 20 µg daily x 6 months, calcium 1000 mg daily x 6 months, vitamin D 1000 IU daily x 6 months, and treadmill stepping 3 times/week (20 to 40 min. stepping time at 1.8 to 2.5 km/h) for 6 months using Lokomat driven gait orthosis and partial body-weight support

Outcome measures: BMD of spine, total hip, and femoral neck by DXA at baseline, 3, 6, and 12 months; micro-MRI of distal tibia at baseline, 3, 6, and 12 months; serum bone markers BAP, CTX-1, P1NP, and OC at baseline, 3, 6, and 12 months

1.        Positive but non-significant changes in lumbar spine & total hip BMD were observed at 6 months

2.      Teriparatide was well tolerated.

* All data expressed as mean±SD, unless expressed otherwise.

Discussion

One study of concurrent teriparatide and body-weight supported treadmill stepping did not provide evidence in support of this combination intervention for the treatment of BMD decline in SCI. However, this study used a convenience sample with small sample size and was not powered to detect significant intervention effects. Three months of electroacupuncture and combination therapy seem to be sufficient to produce positive adaptations in BMD compared to individuals who received combination therapy only.

Conclusion

There is no evidence to support concurrent treatment of low bone mass with teriparatide and body-weight supported treadmill training (Gordon et al. 2013).