The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy

Osteoporosis Clinical Trial

Official title:

The Optimal Long Term Treatment Strategy of Anti-resorptive Medications---The Extension of Denosumab Sequential Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05091086
• Other study ID #: 202107164MINC
• Status: Recruiting
• Phase: Phase 4
• Start date: November 20, 2021
• Est. completion date: December 31, 2030

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 is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.

Description:

This study intends to use a randomized trial to test whether the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 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

• Bone Mineral Density
• Osteoporosis

Intervention

Drug:
• Denosumab
Active comparator: persistent treatment of denosumab. Experimental: alternating treatment with zoledronate and denosumab

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 femoral neck Bone mineral density of femoral neck	Bone mineral density of femoral neck	7 years
Secondary	Bone mineral density of lumbar spine	Bone mineral density of lumbar spine	7 years
Secondary	Bone mineral density of total hip	Bone mineral density of total hip	7 years