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

Primary Purpose

Spinal Cord Injury, Bone Loss, Osteoporosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Alendronate

Calcium

Vitamin D

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Teriparatide, Alendronate, Alendronic Acid, Osteoporosis, Bone Fracture, Bone Loss, 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

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alendronate, Calcium, Vitamin D

Arm Description

Drug: Weekly oral alendronate 70 mg for 12 months Supplements: 1000 mg Calcium and 1000 IU Vitamin D daily for 12 months

Outcomes

Primary Outcome Measures

BMD of Total Hip by DXA

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.

Secondary Outcome Measures

C-terminal Telopeptide (CTX)

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.

BMD by DXA at the Lumbar Spine

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.

Amino-terminal Propeptide of Type 1 Collagen (P1NP)

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.

Bone-specific Alkaline Phosphatase (BSAP)

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.

Full Information

NCT ID

NCT02195895

First Posted

July 14, 2014

Last Updated

March 28, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT02195895

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

April 2014 (Actual)

Primary Completion Date

August 5, 2016 (Actual)

Study Completion Date

August 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injury, Bone Loss, Osteoporosis

Keywords

Teriparatide, Alendronate, Alendronic Acid, Osteoporosis, Bone Fracture, Bone Loss, 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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alendronate, Calcium, Vitamin D

Arm Type

Experimental

Arm Description

Drug: Weekly oral alendronate 70 mg for 12 months Supplements: 1000 mg Calcium and 1000 IU Vitamin D daily for 12 months

Intervention Type

Drug

Intervention Name(s)

Alendronate

Other Intervention Name(s)

Alendronic acid, Fosamax

Intervention Description

Weekly oral alendronate 70 mg for 12 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium

Other Intervention Name(s)

Calcium carbonate, Antacid

Intervention Description

Daily oral 1000 mg Calcium

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D

Other Intervention Name(s)

Vitamin D3, Cholecalciferol

Intervention Description

Daily oral 1000 IU

Primary Outcome Measure Information:

Title

BMD of Total Hip by DXA

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

C-terminal Telopeptide (CTX)

Description

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.

Time Frame

12 months

Title

BMD by DXA at the Lumbar Spine

Description

Time Frame

12 months

Title

Amino-terminal Propeptide of Type 1 Collagen (P1NP)

Description

Time Frame

12 months

Title

Bone-specific Alkaline Phosphatase (BSAP)

Description

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas J Schnitzer, MD, PhD

Organizational Affiliation

Northwestern University Feinberg School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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