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

Not Applicable

• Conditions: Primary osteoporosis; osteoporosis; D010024

• Registration Number: JPRN-jRCT1041190094
• Lead Sponsor: Kobayakawa Tomonori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone density change (lumbar spine,total hip)

Secondary Outcome Measures

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