The Optimal Sequential Therapy After Long Term Denosumab Treatment

NCT05091099 | Completed Phase 4

• 1 other identifier: 202108044MINA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoporosis

Keywords

Osteoporosis; denosumab; alendronate; zoledronic acid

Outcome Measures

Primary Outcomes (1)

• Bone mineral density of lumbar spine

  Bone mineral density of lumbar spine

  one year

Secondary Outcomes (4)

• Bone mineral density of femoral neck

  one year

• Bone mineral density of total hip

  one year

• bone turnover markers

  13 months

• clinical osteoporotic fracture

  1 year

Study Arms (2)

On time Zoledronate

ACTIVE COMPARATOR

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

Drug: zoledronate

Alendronate and Zoledronate

EXPERIMENTAL

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 and Zoledronate

Interventions

zoledronate DRUG

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

Also known as: Zoledronic acid

On time Zoledronate

Alendronate and Zoledronate 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).

Alendronate and Zoledronate

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital, Yunlin branch

Douliu, Yunlin County, 640, Taiwan

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Zoledronic Acid; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 25, 2021
• Study Start: January 10, 2022
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

TW (1)