NCT00372372

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

September 28, 2007

Status Verified

September 1, 2007

First QC Date

September 5, 2006

Last Update Submit

September 27, 2007

Conditions

Osteoporosis

Keywords

corticosteroids, bone mineral, risedronate, bisphosphonate

Outcome Measures

Primary Outcomes (1)

  • bone mineral density

Secondary Outcomes (1)

  • Adverse events, new vertebral fractures

Interventions

risedronateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Age\>=18 years and \<75 years.

You may not qualify if:

  • Pregnant or lactating women.
  • Uncorrected hypocalcemia.
  • History of esophageal stricture.
  • Previous intolerance or hypersenstivity to biphosphonates.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuen Mun Hospital

Hong Kong, China

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • CC Mok, MD FRCP

    Tuen Mun Hospital Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 6, 2006

Study Start

January 1, 2004

Study Completion

April 1, 2007

Last Updated

September 28, 2007

Record last verified: 2007-09

Locations

CN(1)