Christina V Oleson1,2, Ralph J Marino3, Christopher S Formal3,4, Christopher M Modlesky5, Benjamin E Leiby6. 1. Department of Physical Medicine and Rehabilitation, Case Western Reserve University, Cleveland, OH, USA. christinavoleson@msn.com. 2. MetroHealth Medical Center, SCI Program, 4229 Pearl Road, Cleveland, OH, USA. christinavoleson@msn.com. 3. Department of Rehabilitation Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA. 4. Magee Rehabilitation Hospital, Philadelphia, PA, USA. 5. Department of Kinesiology, University of Georgia, Athens, GA, USA. 6. Department of Pharmacology and Experimental Therapeutics, Division of Biostatistics, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.
Abstract
STUDY DESIGN: Randomized double blind, placebo-controlled trial. OBJECTIVES: To examine the effect of early intravenous zoledronic acid (ZA) on bone markers and areal bone mineral density (aBMD) in persons with acute ASIA Impairment Scale (AIS) A traumatic spinal cord injury (SCI). SETTING: Two inpatient rehabilitation units. METHODS:Thirteen men, 2 women, aged 19-65, C4-T10 AIS A SCI, received5 mg intravenous ZA vs. placebo 12-21 days post injury. Markers of bone formation (procollagen N-1 terminal propeptide [P1NP]), bone resorption (serum C-telopeptide [CTX]), and aBMD by dual-energy X-ray absorptiometry (DXA) for hip (femur-proximal, intertrochanteric, neck), and knee (distal femur, proximal tibia) were obtained at baseline, 2 weeks post infusion (P1NP, CTX only), 4 and 12 months post injury. RESULTS:P1NP remained unchanged, while CTX decreased in ZA but increased in controls at 2 weeks (mean difference = -97%, p < 0.01), 4 months (mean difference = -54%, p < 0.05), but not 12 months (mean difference = 3%, p = 0.23). Changes in aBMD at the hip favored ZA at 4 months (mean difference 10.3-14.1%, p < 0.01) and 12 months (mean difference 10.8-13.1%, p < 0.02). At 4 months, changes in aBMD favored ZA at the distal femur (mean difference 6.0%, 95% CI: 0.7-11.2, p < 0.03) but not proximal tibia (mean difference 8.3%, 95% CI: -6.9 to 23.6, p < 0.23). Both groups declined in aBMD at 12 months, with no between group differences. CONCLUSION:ZA administered ≤21 days of complete traumatic SCI maintains aBMD at the hip and distal femur at 4 months post injury. This effect is partially maintained at 12 months.
RCT Entities:
STUDY DESIGN: Randomized double blind, placebo-controlled trial. OBJECTIVES: To examine the effect of early intravenous zoledronic acid (ZA) on bone markers and areal bone mineral density (aBMD) in persons with acute ASIA Impairment Scale (AIS) A traumatic spinal cord injury (SCI). SETTING: Two inpatient rehabilitation units. METHODS: Thirteen men, 2 women, aged 19-65, C4-T10 AIS A SCI, received 5 mg intravenous ZA vs. placebo 12-21 days post injury. Markers of bone formation (procollagen N-1 terminal propeptide [P1NP]), bone resorption (serum C-telopeptide [CTX]), and aBMD by dual-energy X-ray absorptiometry (DXA) for hip (femur-proximal, intertrochanteric, neck), and knee (distal femur, proximal tibia) were obtained at baseline, 2 weeks post infusion (P1NP, CTX only), 4 and 12 months post injury. RESULTS: P1NP remained unchanged, while CTX decreased in ZA but increased in controls at 2 weeks (mean difference = -97%, p < 0.01), 4 months (mean difference = -54%, p < 0.05), but not 12 months (mean difference = 3%, p = 0.23). Changes in aBMD at the hip favored ZA at 4 months (mean difference 10.3-14.1%, p < 0.01) and 12 months (mean difference 10.8-13.1%, p < 0.02). At 4 months, changes in aBMD favored ZA at the distal femur (mean difference 6.0%, 95% CI: 0.7-11.2, p < 0.03) but not proximal tibia (mean difference 8.3%, 95% CI: -6.9 to 23.6, p < 0.23). Both groups declined in aBMD at 12 months, with no between group differences. CONCLUSION:ZA administered ≤21 days of complete traumatic SCI maintains aBMD at the hip and distal femur at 4 months post injury. This effect is partially maintained at 12 months.
Authors: D Roberts; W Lee; R C Cuneo; J Wittmann; G Ward; R Flatman; B McWhinney; P E Hickman Journal: J Clin Endocrinol Metab Date: 1998-02 Impact factor: 5.958