Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.

Risedronate for Prevention of Osteoporosis After Spinal Cord Injury

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00150696

Enrollment

Registered

2005-09-08

Start date

2000-02-29

Completion date

2005-11-30

Last updated

2007-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Spinal Cord Injury.

Keywords

Osteoporosis, Spinal Cord Injury

Brief summary

The purpose of this study is to find out if Risedronate works to prevent osteoporosis after spinal cord injury.

Interventions

DRUGRisedronate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Traumatic spinal cord injury less than 100 days. * Must be able to swallow tablets and sit upright.

Exclusion criteria

* Bilateral knee flexion contractures. * Pregnant, lactating or post-menopausal females. * Paget's disease, osteomalacia, steroid induced bone loss, untreated thyroid disease, iritis, uveitis, pancreatitis, gastritis, peptic ulcer or cholecystitis. * Treatment in the last year with calcitonin, fluoride or anabolic steroid. * Concurrent treatment with prednisone.

Design outcomes

Primary

Measure	Time frame
Change in bone mineral density of the distal femur and proximal tibia between baseline, 12-months and 24-months.	—

Secondary

Measure	Time frame
Change in bone mineral density of the total body, spine and femoral neck between baseline, 12-months and 24-months.	—
Change in biochemical markers of bone turnover between baseline, 12-months and 24-months.	—
Frequency and severity of adverse events.	—
Quality of life.	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026