Comparison of Denosumab and Zoledronate following Romosozumab

Not Applicable

• Conditions: Osteoporosis; D010024; osteoporosis, denosumab, zoledronate, romosozumab

• Registration Number: JPRN-jRCT1051220150
• Lead Sponsor: Takahashi Shinji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Patients on romosozumab for osteoporosis who are 50 years of age or older and have one of the following criteria at the time of starting romosozumab
1. bone mineral density less than 2.5 SD and more than 1 fragility fracture
2. lumbar spine bone density less than -3.3 SD
3. more than 2 existing vertebral fractures
4. semi-quantitative evaluation method result of existing vertebral fracture is Genant grade 3.
5. judged to be necessary to improve surgical outcomes for osteoporosis
6. more than 7.5 mg of steroids (more than 3 months) and T-score <-2.5
Bone fracture despite treatment with bone resorption inhibitors
8. persistent loss of bone mineral density despite treatment with bone resorption inhibitors

Translated with www.DeepL.com/Translator (free version)

Exclusion Criteria

1. patients with severe renal dysfunction (creatinine clearance <35 mL/min)
2. patients with a history of hypersensitivity to denosumab or bisphosphonates
3. patients with dehydration (high fever, severe diarrhea, vomiting, etc.)
4. patients with hypocalcemia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mineral density (Lumbar spine, Total hip)

Secondary Outcome Measures

Name	Time	Method
Bone metabolism (P1NP, TRACP-5b)