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

Tuen Mun Hospital

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: risedronate

Study type: Interventional

Funder types: Other

Identifiers

NCT00372372

HARECCTR0500019

Details and patient eligibility

About

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

Full description

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind