Prevention of Bone Loss After Acute SCI by Zoledronic Acid
Condition: Spinal Cord Injury; Acute Spinal Cord Injury; Bone Loss; Osteoporosis
MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries
Intervention: Zoledronic acid; Placebo
Intervention description: Intravenous infusion of zoledronic acid 5 mg.; Placebo (saline) infusion to match zoledronic acid
Intervention MeSH terms: Zoledronic Acid; Diphosphonates
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Osteoporosis; Spinal Cord Injury; Bone Diseases; Metabolic Bone Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Nervous System; Wounds and Injuries; Bone Density Conservation Agents; Physiological Effects of Drugs; Pharmacologic Actions; Department of Defense

Summary:

      The overall objective of this study is to define an effective therapeutic approach, using
      currently available medication, to prevent or mitigate the loss of bone mass and bone
      strength that occurs after acute spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In-patient at Rehabilitation Institute of Chicago (RIC) or an outpatient who was
             recently discharged from RIC

          -  Males and females

          -  Age >/=18 years

          -  Medically stable in the opinion of subject's physiatrist

          -  SCI at within 120 days inclusive at time of screening

          -  SCI with inability to ambulate independently

          -  ASIA Impairment Scale (AIS) A, B, or C, at time of study entry

          -  Capable of positioning to have DXA performed

          -  Able to tolerate acetaminophen

          -  No known endocrinopathies (diabetes type 1 or 2 can be included)

          -  Normal TSH levels

          -  Normal 25-OH vitamin D levels (>/= 20 ng/ml) at baseline (subjects may be repleted)

          -  Normal calcium levels

          -  Normal renal function (creatinine <2.0 mg/dl)

          -  Well hydrated with adequate intake of liquids

          -  Able to return for all follow-up visits

          -  Capable of reading and understanding informed consent document

          -  Males and females of childbearing potential must be willing and able to use double
             barrier method of contraception for 2 months after having received study drug

        Exclusion Criteria:

          -  Have Paget's disease of the bone

          -  Malignancy as a cause of acute SCI

          -  Have unexplained high levels of alkaline phosphatase in blood

          -  Any active gastrointestinal condition that results in malabsorption

          -  Poor dental hygiene or requirement for invasive dental procedure within two months
             prior to enrollment

          -  History of bone metastasis and skeletal malignancies

          -  History of alcoholism or drug abuse within the 2 years prior to study screening

          -  Other medical conditions that in the opinion of the investigator would preclude the
             subject from completing the study

          -  Elevated liver function tests >2x normal

          -  Currently being prescribed anti-convulsants at a dose or frequency that is determined
             to interfere with bone metabolism as determined by the investigator

          -  Currently being prescribed glucocorticoids, other than inhaled glucocorticoids

          -  Current or recent use any bone-active agents, including any bisphosphonate,
             raloxifene, hormone therapy (estrogen and estrogen/progestin), calcitonin or
             strontium-containing compounds within 60 days of screening.

          -  Pregnant, planning to become pregnant, or lactating