The Optimal Sequential Therapy After Long Term Denosumab Treatment

Phase 4

Recruiting

• Conditions: Osteoporosis
• Interventions: Drug: Alendronate

• Registration Number: NCT05091099
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

This study intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.

Detailed Description

This study intends to use a randomized trial to test whether Alendronate and Zoledronate can avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2021-10-22
• Last Update Submitted: 2021-10-22
• Study First Posted: 2021-10-25
• Last Update Posted: 2021-10-25
• Study Start: 2021-11-20
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. Postmenopausal women or men over 50 years old
2. Denosumab treatment for at least two years and less than three years (up to five doses).

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
On time Zoledronate	Alendronate	Zoledronate would be given (one dose for one year) after the completiong of denosumab on time
Alendronate and Zoledronate	Alendronate	Alendronate would be given one month before the the completiong of denosumab and the following 3 months (Total four months). After the completion of Alendronate, Zoledronate would be given (one dose).

Primary Outcome Measures

Name	Time	Method
Bone mineral density of lumbar spine	one year	Bone mineral density of lumbar spine

Secondary Outcome Measures

Name	Time	Method
Bone mineral density of femoral neck	one year	Bone mineral density of femoral neck
Bone mineral density of total hip	one year	Bone mineral density of total hip

Trial Locations

Locations (1)

National Taiwan University Hospital, Yunlin branch; 🇨🇳 Douliu, Yunlin County, Taiwan