Prevention of Bone Loss After Acute SCI by Zoledronic Acid

Osteoporosis Clinical Trial

Official title:

Prevention of Bone Loss After Acute SCI by Zoledronic Acid: Durability, Effect on Bone Strength, and Use of Biomarkers to Guide Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325414
• Other study ID #: STU00098239
• Secondary ID: A-18350
• Status: Completed
• Phase: Phase 2
• Start date: February 2015
• Est. completion date: August 25, 2020

Study information

• Verified date: June 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized, double-blind placebo-controlled study of zoledronic acid to evaluate its efficacy and safety over a 2 year period for the prevention of bone loss and maintenance of bone strength in individuals with recent onset SCI (see diagram below). Subjects will be randomized at the baseline visit to receive either zoledronic acid or placebo. At the end of the first year of the study, each treatment group will be re-randomized to either zoledronic acid or placebo to evaluate the durability of response to zoledronic acid and the utility of serum bone markers to guide therapeutic decision making. DXA imaging, CT imaging and bone markers will be obtained at baseline, 3 months, 6 months, 12 months, 18 months and 24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 25, 2020
• Est. primary completion date: August 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Bone Loss
• Osteoporosis
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Drug:
• Zoledronic acid
Intravenous infusion of zoledronic acid 5 mg.
• Placebo
Placebo (saline) infusion to match zoledronic acid

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percent Change in the Epiphyseal Integral Bone Mass Content (iBMC) of the Femur	Percent change in the epiphyseal integral bone mass content (iBMC) of the femur, as collected by CT.	0-12 months
Secondary	Percent Change in the Metaphyseal Integral Bone Mass Content (iBMC) of the Femur	Percent change in the metaphyseal integral bone mass content (iBMC) of the femur, as collected by CT	0-12 months