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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-08-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Cord Injury Bone Loss Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Alendronate

Intervention Type DRUG

Weekly oral alendronate 70 mg for 12 months

Calcium

Intervention Type DIETARY_SUPPLEMENT

Daily oral 1000 mg Calcium

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Daily oral 1000 IU

Interventions

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Alendronate

Weekly oral alendronate 70 mg for 12 months

Intervention Type DRUG

Calcium

Daily oral 1000 mg Calcium

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

Daily oral 1000 IU

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Alendronic acid Fosamax Calcium carbonate Antacid Vitamin D3 Cholecalciferol

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No