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Effect of Alendronate on Bone in People With Chronic Spinal Cord Injury (SCI) Previously Treated With Teriparatide

NCT02195895 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-03-30

Study results available
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Summary

The purpose of this study is to determine if a year of alendronate treatment will maintain or increase bone mass density (BMD) compared to baseline BMD values in people with chronic spinal cord injury (SCI).

This study will also investigate 1) if alendronate therapy will increase bone strength in people with chronic SCI, 2) the number of participants with adverse events from alendronate, and 3) the effects of alendronate on serum markers of bone metabolism.

Conditions

Interventions

DRUG

Alendronate

Weekly oral alendronate 70 mg for 12 months

DIETARY_SUPPLEMENT

Calcium

Daily oral 1000 mg Calcium

DIETARY_SUPPLEMENT

Vitamin D

Daily oral 1000 IU

Sponsors & Collaborators

Principal Investigators

  • Thomas J Schnitzer, MD, PhD · Northwestern University Feinberg School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-08-05
Completion
2016-08-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02195895 on ClinicalTrials.gov