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

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 - A randomized prospective study to compare the efficacy and safety between once-weekly and daily alendronate therapy in patients with corticosteroid-induced osteoporosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001082

Enrollment

130

Registered

2008-04-01

Start date

2008-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Corticosteroid-induced osteoporosis

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are seeing in out patient clinic or hospitalized in Keio University Hospital. Patients who take more than 5 mg daily dose of prednisolone.Patients who can understand the aim of this study and consent to participate in this study.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Mean percent change in bone mineral density (BMD) of lumbar spine at 48 weeks	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactShinji Sato

Keio University School of Medicine Internal Medicine

03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026