An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis

An open label, single institute, single arm trial of efficacy and safety of the anti-RANKL monoclonal antibody (Denosumab) for patients with steroid-induced osteoporosis - OSRANKLE-SIO study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011461

Enrollment

130

Registered

2013-08-12

Start date

2013-08-01

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

steroid induced osteoporosis

Interventions

Patients will be subcutaneous injected subcutaneously with 60 mg of denosumab every 6 months for 12 months. All subjects will be treated with daily pills containing calcium, naive Vitamin D, with ma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Plan to use or administration of oral steroid for more than 3 months With written informed consent

Exclusion criteria

Exclusion criteria: 1)Cancer patients with bone metastasis or expected bone metastasis 2)Hypocalcemia 3)Women who wish to be pregnant or are pregnant, or in lactation 4)Hypersensitivity to the denosumab 5)Cancer patients on cancer treatment or anti-hormonal therapy 6)Dental therapy during this trial 7)Long term use of bisphosphonate and have atypical fracture 8)Severe skin infection

Design outcomes

Primary

Measure	Time frame
Change in bone mineral density of lumber spine In case of spinal bone osteo-sclerosis or spinal bone fracture, femoral neck or distal 2th finger will be substituted Incidence rate of pathological bone fracture Fracture was validated by x-ray and/or MRI scan	—

Secondary

Measure	Time frame
Change in bone metabolism markers NTX(serum , urine), bone-type alkaline phosphatase, Magnesium, Calcium, phosphorus, intact PTH, calcitonin Correlation between bone mineral density and activated vitamin D blood concentration levels Numerical rating score will be measured for pain	—

Countries

Japan

Contacts

Public ContactKazumasa Yokoyama

Juntendo University School of Medicine Neurology

kazumasa@juntendo.ac.jp03-3813-3111

Outcome results

None listed

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