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

March 28, 2023 updated by: Thomas J. Schnitzer, Northwestern University

12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This extension study will enroll individuals who have completed treatment in the parent protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury" or in the teriparatide extension protocol. This study will allow those individuals who previously received teriparatide to be treated for a year with alendronate to maintain any bone they may have gained and to possibly increase bone mass further. Termination of teriparatide is followed by bone loss if anti-resorptive therapy is not initiated, so this approach is optimal for continued treatment of the current group of participants.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prior enrollment in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury", (NCT01225055).
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
  • Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  • Individual with renal insufficiency (calculated creatinine clearance < 30 ml/min).
  • Individuals who are not able to sit or stand upright for at least 30 minutes after taking their medication.
  • Individuals with poor dental hygiene.
  • Individuals with esophageal abnormalities.
  • Individuals who are not able to tolerate alendronate treatment.
  • Individuals who will not be able to return for all study visits.
  • Patients may not be receiving any other investigational agents.
  • Other medical conditions that in the opinion of the investigator would preclude the subject from completing the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alendronate, Calcium, Vitamin D

Drug: Weekly oral alendronate 70 mg for 12 months

Supplements: 1000 mg Calcium and 1000 IU Vitamin D daily for 12 months
Drug: Alendronate
Weekly oral alendronate 70 mg for 12 months
Other Names:
  • Fosamax
  • Alendronic acid
Dietary supplement: Calcium
Daily oral 1000 mg Calcium
Other Names:
  • Calcium carbonate
  • Antacid
Dietary supplement: Vitamin D
Daily oral 1000 IU
Other Names:
  • Cholecalciferol
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMD of Total Hip by DXA
Time Frame: 12 months
The mean percent change in bone mineral density (BMD) of the hip after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-terminal Telopeptide (CTX)
Time Frame: 12 months
The mean percent change in C-terminal telopeptide (CTX) from baseline after 12 months of treatment. CTX is a bone marker found in blood serum and measures the rate of bone breakdown.
12 months
BMD by DXA at the Lumbar Spine
Time Frame: 12 months
The mean percent change in bone mineral density (BMD) in the lumbar spine after 12 months of treatment. BMD was evaluated by dual-energy X-ray absorptiometry (DXA). DXA scans measure bone density in different areas of the body using low-dose X-ray beams.
12 months
Amino-terminal Propeptide of Type 1 Collagen (P1NP)
Time Frame: 12 months
The mean percent change in amino-terminal of type 1 collagen (P1NP) from baseline after 12 months of treatment. P1NP is a bone marker found in blood serum and provides information about how fast the body is making new bone.
12 months
Bone-specific Alkaline Phosphatase (BSAP)
Time Frame: 12 months
The mean percent change in bone-specific alkaline phosphatase (BSAP) after 12 months of treatment. BSAP is a bone marker found in blood serum and measures the rate of bone breakdown.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University Feinberg School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

August 5, 2016

Study Completion (Actual)

August 5, 2016

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00083759

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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