Verification of efficacy and safety of bisphosphonates or denosumab for patients with osteoporosis after treatment with romosozumab

JRCT ID: jRCT1041190094

Registered date:12/12/2019

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Primary osteoporosis
• Date of first enrollment: 12/12/2019
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Ibandronate sodium hydrate or denosumab is administered to osteoporosis patients after romosozumab administration.
arm Ibandorontae: ibandoronate 100mg once every 1 month for 12 months
arm Denosumab: denosumab 60mg s.c. once every 6months for 12months

Outcome(s)

• Primary Outcome: Bone density change (lumbar spine,total hip)

Secondary Outcome

1.Bone density (total hip, femoral neck) at 6 months,
2.Bone turneover markers at 6 months and 12 months
3.Adverse events at 12 months
4.New vertebral fracture,hip fracture at 12 months

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 100age old
• Gender: Both

Include criteria

1. Primary osteoporosis
2. Patients who used romosozumab for 12 months
3. Written informed consent

Exclude criteria

1.Patients who are allergic to lomosozumab and ibandronate
2.hypocalcemia
3.Pregnant or breastfeeding women
4.Patients with reflux esophagitis, esophageal achalasia
5.Patients who cannot keep standing or sitting for more than 60 minutes
6.GFR30mL/min/1.73m2 or less, Dialysis patients
7.Patients with upper gastrointestinal disorders such as dysphagia, esophagitis, gastritis, duodenal
inflammation, ulcers
8.Patients judg ed to be inappropriate for study

Related Information

• Primary Sponsor: Kobayakawa Tomonori