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Teriparatide and Vibration in Chronic Spinal Cord Injury
NCT01225055Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2010
- Primary completion
- Aug 2015
- Countries
- 1
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- teriparatide
- Conditions
- osteoporosis
01
Overview
Phase 2, randomised, double-blind trial of teriparatide in osteoporosis (3 arms). Primary endpoint: Bone Mineral Density of the Total Hip as Assessed by DXA at 12 months. Started Oct 2010; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Teriparatide
Teriparatide alone with sham vibration
Vibration
Vibration alone with placebo-teriparatide
Teriparatide and vibration
Teriparatide with vibration applied in conjunction
03
Who it enrols
Adults >21 years with chronic spinal cord injury, inability to ambulate independently, and low bone mass at the total hip, with normal renal, liver, and thyroid function, excluding those with prior PTH use, recent bone-active agents, or history of malignancy.
04
Endpoints
Primary
Bone Mineral Density of the Total Hip as Assessed by DXA
Secondary
Bone Mineral Density by DXA at the Lumbar Spine
Bone Mineral Density by DXA at Femoral Neck
C-terminal Telopeptide
Bone-specific Alkaline Phosphatase
Amino-terminal Propeptide of Type 1 Collagen
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