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The Efficacy of Risedronate in Prevention of Bone Loss in Patients Receiving High Dose Corticosteroid Treatment

NCT ID: NCT00372372

Last Updated: 2007-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-04-30

Brief Summary

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The efficacy of risedronate in prevention of bone loss in patients receiving high dose corticosteroid treatment

Detailed Description

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We compare the effect of risedronate with placebo in bone mineral density changes in patients receiving high dose corticosteroids for their underlying diseases

Conditions

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Osteoporosis

Keywords

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corticosteroids, bone mineral, risedronate, bisphosphonate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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risedronate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients with various medical conditions who require high dose glucocorticoid treatment: (1) pulse methylprednisolone; (2) oral prednisolone (\>=0.8mg/kg/day) or equivalent for at least 6 weeks.
2. Age\>=18 years and \<75 years.

Exclusion Criteria

1. Pregnant or lactating women.
2. Uncorrected hypocalcemia.
3. History of esophageal stricture.
4. Previous intolerance or hypersenstivity to biphosphonates.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tuen Mun Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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CC Mok, MD FRCP

Role: PRINCIPAL_INVESTIGATOR

Tuen Mun Hospital Hong Kong

Locations

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Tuen Mun Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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HARECCTR0500019

Identifier Type: -

Identifier Source: org_study_id