Prevention of Bone Loss After Acute SCI by Zoledronic Acid

NCT02325414 | Completed Phase 2 Results DMC

• 2 other identifiers: STU00098239CDMRP-130125
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spinal Cord Injury; Acute Spinal Cord Injury; Bone Loss; Osteoporosis

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

Outcome Measures

Primary Outcomes (2)

• Percent Change in Bone Mass Density (BMD) in the Hip

  Percent change of bone mass density (BMD) in the total hip (as measured by DXA)

  0-12 months

• Percent Change of Bone Mass Density (BMD) in the Femoral Neck

  Percent change of bone mass density (BMD) in the femoral neck (as measured by DXA)

  0-12 months

Secondary Outcomes (2)

• Percent Change in the Epiphyseal Integral Bone Mass Content (iBMC) of the Femur

  0-12 months

• Percent Change in the Metaphyseal Integral Bone Mass Content (iBMC) of the Femur

  0-12 months

Study Arms (2)

Zol

EXPERIMENTAL

Intravenous infusion of zoledronic acid (zol) 5 mg at baseline.

Drug: Zoledronic acid

Placebo

EXPERIMENTAL

Intravenous infusion of placebo at baseline.

Drug: Placebo

Interventions

Zoledronic acid DRUG

Intravenous infusion of zoledronic acid 5 mg.

Also known as: Reclast, Zometa, Bisphosphonate

Zol

Placebo DRUG

Placebo (saline) infusion to match zoledronic acid

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (2)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Edwards WB, Haider IT, Simonian N, Barroso J, Schnitzer TJ. Durability and delayed treatment effects of zoledronic acid on bone loss after spinal cord injury: a randomized, controlled trial. J Bone Miner Res. 2021 Nov;36(11):2127-2138. doi: 10.1002/jbmr.4416. Epub 2021 Jul 29.

  PMID: 34278611 DERIVED

• Haider IT, Lobos SM, Simonian N, Schnitzer TJ, Edwards WB. Bone fragility after spinal cord injury: reductions in stiffness and bone mineral at the distal femur and proximal tibia as a function of time. Osteoporos Int. 2018 Dec;29(12):2703-2715. doi: 10.1007/s00198-018-4733-0. Epub 2018 Oct 17.

  PMID: 30334093 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Bone Diseases, Metabolic; Osteoporosis; Bone Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries

Interventions

Zoledronic Acid; Diphosphonates; Sodium Chloride

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The number of participants in the trial was limited, particularly during the second year in each subgroup. Additionally, the number of women studied was limited but was representative of the general sex distribution observed in people with spinal cord injury.

Results Point of Contact

• Title: Dr. Thomas Schnitzer
• Organization: Northwestern University

tjs@northwestern.edu

312-503-4043

Study Officials

• Thomas J Schnitzer, MD, PhD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2014
• First Posted: December 25, 2014
• Study Start: February 1, 2015
• Primary Completion: August 25, 2020
• Study Completion: August 25, 2020
• Last Updated: December 2, 2025
• Results First Posted: June 2, 2021

Record last verified: 2025-11

Locations

US (2)