The Optimal Sequential Therapy After Long Term Denosumab Treatment

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05091099

Collaborator

(none)

Enrollment

Location

Arms

49.3

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Alendronate	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

One arm accept on time zoledronic acid after long-tearm denosumab. Another arm accept alendronate for 4 months and then zoledronic acid after long-tearm denosumab.One arm accept on time zoledronic acid after long-tearm denosumab. Another arm accept alendronate for 4 months and then zoledronic acid after long-tearm denosumab.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Optimal Sequential Therapy After Long Term Denosumab Treatment

Anticipated Study Start Date :

Nov 20, 2021

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: On time Zoledronate Zoledronate would be given (one dose for one year) after the completiong of denosumab on time	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). Other Names: Zoledronic acid
Experimental: 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).	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). Other Names: Zoledronic acid

Arm

Intervention/Treatment

Active Comparator: On time Zoledronate

Zoledronate would be given (one dose for one year) after the completiong of denosumab on time

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).

Other Names:

Zoledronic acid

Experimental: 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).

Drug: Alendronate

Other Names:

Zoledronic acid

Outcome Measures

Primary Outcome Measures

Bone mineral density of lumbar spine [one year]
Bone mineral density of lumbar spine

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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