The Optimal Sequential Therapy After Long Term Denosumab Treatment

NCT ID: NCT05091099

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2025-11-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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On time Zoledronate

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

Group Type ACTIVE_COMPARATOR

zoledronate

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Alendronate and Zoledronate

Intervention Type DRUG

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).

Interventions

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zoledronate

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

Intervention Type DRUG

Alendronate and Zoledronate

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).

Intervention Type DRUG

Other Intervention Names

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Zoledronic acid

Eligibility Criteria

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Inclusion Criteria

1. Postmenopausal women or men over 50 years old
2. Continuous Denosumab treatment for at least three years (up to six doses).

Exclusion Criteria

1. Secondary osteoporosis
2. Metabolic bone diseases
3. Active or prior malignancy
4. Ongoing systemic glucocorticoid therapy
5. Current use of hormone replacement therapy
6. Current use of any medication known to affect bone metabolism
7. Prior use of any osteoporosis medication other than denosumab
8. Estimated glomerular filtration rate (eGFR) \< 40 mL/min
9. Known hypersensitivity to zoledronic acid
10. Hypocalcemia
11. Any other contraindication to zoledronic acid
12. Age \> 85 years
13. Esophageal abnormalities that delay esophageal emptying (e.g., esophageal stricture, achalasia)
14. Inability to stand or sit upright for at least 30 minutes
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Taiwan University Hospital, Yunlin branch

Douliu, Yunlin County, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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202108044MINA

Identifier Type: -

Identifier Source: org_study_id

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