The Optimal Sequential Therapy After Long Term Denosumab Treatment

Osteoporosis Clinical Trial

Official title:

The Optimal Sequential Therapy After Long Term Denosumab Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05091099
• Other study ID #: 202108044MINA
• Status: Recruiting
• Phase: Phase 4
• Start date: November 20, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2021
• Source: National Taiwan University Hospital
• Contact: Shau-Huai Fu, Doctor
• Phone: +886972655734
• Email: b90401045[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Alendronate
On time Zoledronate: Zoledronate would be given (one dose for one year) after the completiong of denosumab on time Alendronate and Zoledronate: 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).

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Yunlin branch	Douliu	Yunlin County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density of lumbar spine	Bone mineral density of lumbar spine	one year
Secondary	Bone mineral density of femoral neck	Bone mineral density of femoral neck	one year
Secondary	Bone mineral density of total hip	Bone mineral density of total hip	one year