Comparison of Denosumab and Zoledronate following Romosozumab

JRCT ID: jRCT1051220150

Registered date:20/01/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Osteoporosis
• Date of first enrollment: 20/01/2023
• Target sample size: 65
• Study type: Interventional
• Intervention(s): Denosumab or zoledronate after romosozumab

Outcome(s)

• Primary Outcome: Bone mineral density (Lumbar spine, Total hip)
• Secondary Outcome: Bone metabolism (P1NP, TRACP-5b)

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include 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

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Exclude 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

Related Information

• Primary Sponsor: Takahashi Shinji