CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Alendronate +2 moredrug
Likely dose
Alendronate 70 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02195895
NCT02195895Phase 2Completed
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12 Month Open-Label Extension Study of the Effect of Alendronate on Bone in People With Chronic SCI Previously Treated With Teriparatide

Northwestern University·interventional·Posted Jul 21, 2014·Updated Mar 30, 2023

In Brief

A Phase 2 clinical trial evaluating Alendronate, Calcium, and 1 other intervention for Spinal Cord Injury and 2 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injury, Bone Loss, Osteoporosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 21, 2014
Enrollment StartApr 1, 2014
Primary CompletionAug 5, 2016
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.9 years ago

Interventions

Alendronatedrug

Weekly oral alendronate 70 mg for 12 months

Calciumdietary

Daily oral 1000 mg Calcium

Vitamin Ddietary

Daily oral 1000 IU