Department of Orthopedics, National Taiwan University Hospital

Who is this study for? Older adult patients with Osteoporosis
What treatments are being studied? Denosumab
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 resorption reaching twice baseline levels for about 6 months. How to prevent bone loss after denosumab therapy is an important issue, especially when considering the compliance, persistence, or other comorbidities of the patient. We want to verify if zoledronic acid could be used as a sequential therapy after denosumab to prevent rapid bone loss by randomized clinical trial.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 80
Healthy Volunteers: No
View:

• Postmenopausal women

• Men >50-year-old

• After Denosumab treatment ≥ 2 years due to osteoporosis

Locations
Other Locations
Taiwan
Department of Orthopedics, National Taiwan University Hospital
Recruiting
Taipei
Contact Information
Primary
Shau-Huai Fu
b90401045@gmail.com
+886972655734
Time Frame
Start Date: April 12, 2019
Estimated Completion Date: December 31, 2022
Participants
Target number of participants: 100
Treatments
Experimental: Continuous Denosumab
Continuous anti-resorptive therapy by Denosumab for 2 years
Experimental: Zoledronic acid to Denosumab
treat with Zoledronic acid for one year and then shift to Denosumab for another one year
Experimental: Continuous Zoledronic acid
Continuous anti-resorptive therapy by Zoledronic acid for 2 years
Experimental: Zoledronic acid to observation
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
Related Therapeutic Areas
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov

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