Denosumab Sequential Therapy

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Zoledronic Acid; Drug: Denosumab

• Registration Number: NCT03868033
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Denosumab is a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis. Although denosumab has excellent effect to increase bone mass and prevent fracture in FREEDOM study with very low complications, even up to ten years, it's effect is reversible. After holding the drug, circulating denosumab levels fall rapidly, and bone resor...

Detailed Description

Denosumab is a monoclonal antibody directed against the protein RANK-L, the principal regulator of osteoclast development. Thus, it acts as a potent anti-resorptive agent and is now widely used in the treatment of osteoporosis. Because it's easily to be used with very low risk of complications, patient has better compliance and persistence of denosumab than ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-06
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-08
• Study Start: 2019-04-12
• Primary Completion: 2023-07-01
• Status Verified: 2023-09
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-04-21
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. Postmenopausal women
2. Men >50-year-old
3. After Denosumab treatment ≥ 2 years due to osteoporosis

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Exclusion Criteria

1. Patientshadeverusedantiosteoporosismedications other than Dmab
2. Estimated glomerular filtration rate <35 ml/min.
3. Malignancy
4. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism
5. Secondary osteoporosis
6. Metabolic bone diseases
7. Contraindications to ZOL
8. Patients older than 80 years old
9. Hypocalcemia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zoledronic acid to Denosumab	Zoledronic Acid	treat with Zoledronic acid for one year and then shift to Denosumab for another one year
Continuous Zoledronic acid	Zoledronic Acid	Continuous anti-resorptive therapy by Zoledronic acid for 2 years
Continuous Denosumab	Denosumab	Continuous anti-resorptive therapy by Denosumab for 2 years
Zoledronic acid to Denosumab	Denosumab	treat with Zoledronic acid for one year and then shift to Denosumab for another one year
Zoledronic acid to observation	Zoledronic Acid	treat with Zoledronic acid for one year and then close follow up by bone turn over marker. resume another dose of Zoledronic acid if elevated CTX level above normal range

Primary Outcome Measures

Name	Time	Method
Changes of lumbar spine, total hip and femoral neck bone mineral density	baseline, 1 year, 2 year	Changes of lumbar spine, total hip and femoral neck bone mineral density from baseline

Secondary Outcome Measures

Name	Time	Method
Clinical osteoporotic fracture	baseline, 1 year, 2 year	Incidence of clinical osteoporotic fracture
Change of bone turnover marker	baseline, 6 months, 12 months, 15 months, 18 months, 24 months	Changes of bone turnover marker, including C-terminal telopeptide of type I collagen (CTX) and propeptide of procollagen type I (P1NP)

Trial Locations

Locations (1)

Department of Orthopedics, National Taiwan University Hospital; 🇨🇳 Taipei, N/A = Not Applicable, Taiwan