A randomized open-label blinded prospective study designed to compare the efficacy and safety between once-weekly and daily administration of alendronate in patients with corticosteroid-induced osteoporosis

UMIN ID: UMIN000001082

Registered date:01/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Corticosteroid-induced osteoporosis
• Date of first enrollment: 2008/03/01
• Target sample size: 130
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Once-weekly group: receive 35mg of alendronate once a week for 52 weeks
Daily group: receive 5mg of alendronate daily for 52 weeks

Outcome(s)

• Primary Outcome: Mean percent change in bone mineral density (BMD) of lumbar spine at 48 weeks
• Secondary Outcome: Mean percent change in BMD of lumbar spine at 24 weeks Mean percent change in BMD of femur trochanter and distal radius at 24 and 48 weeks

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients who take other medicine affected with bone metabolism (other bisphosphonates, calcitonin, vitamin D derivatives, ipriflavone, estrogen derivatives, menaquinones, Raloxifene hydrochloride) within twelve weeks.Patients who have allergic reaction to bisphosphonates.Patients who have esophageal stenosis or akalasia. Patients who cannot keep a sitting position more than 30 minutes.Patients who have sever renal, liver, cardiac dysfunction or hematological disorders. Patients who have metabolic disorders.Patients who have neoplasm.Patients who have hypocarcemia or hypercarcemia.Patients who are pregnant.Patients who are considered to inappropriate to join to this study.

Related Information

• Primary Sponsor: Keio University
• Source(s) of Monetary Support: Teijin Pharmaceuticals