The Optimal Sequential Therapy After Long Term Denosumab Treatment

National Taiwan University

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Alendronate and Zoledronate; Drug: zoledronate

Study type: Interventional

Funder types: Other

Identifiers

NCT05091099

202108044MINA

Details and patient eligibility

About

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

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

On time Zoledronate

Active Comparator group

Description:

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

Treatment:

Drug: zoledronate

Alendronate and Zoledronate

Experimental group

Description:

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).

Treatment:

Drug: Alendronate and Zoledronate