Single arm phase 2 clinical trial of discontinuation of bisphosphonate in patients with aitoimmune diseases

Single arm phase 2 clinical trial of discontinuation of bisphosphonate in patients with aitoimmune diseases - clinical trial of discontinuation of bisphosphonate in patients with aitoimmune diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000023985

Enrollment

120

Registered

2017-04-01

Start date

2017-03-06

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

autoimmune diseases

Interventions

discontinuation of BP and changing to vitamin D supplementation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.age 20 - 60 years old 2.patients of Division of Clinical Nephrology and Rheumatology or Orthopedic Surgery in Niigata University 3.taking mainteinance dose of prednisolone(under 20 mg) 4.taking BP for over five years 5.T score measured by DEXA over -2.5 6.no evidence of past osteoporotic fracture 7.obtained written informed consent

Exclusion criteria

Exclusion criteria: 1.unnecessary of BP according to guideline for the management and treatment of glucocorticoid-induced osteoporosis in Japan 2.inappropriate patients for the clinical trial

Design outcomes

Primary

Measure	Time frame
decreased bone mineral density of femoral neck five years after discontinuation of BP	—

Secondary

Measure	Time frame
1.incidence of beaking 2.incidence of typical femoral fracture 3.change of bone metabolic markers 4.incidence of atypical femoral fracture 5.adverse events 6.risk factors for beaking	—

Countries

Japan

Contacts

Public ContactHiroe Sato

Niigata University Hospital Division of Nephrology and Rheumatology

hiroes@med.niigata-u.ac.jp025-227-2200

Outcome results

None listed

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