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OpenTrials
Completed

NCT Number: NCT05091099

The Optimal Sequential Therapy After Long Term Denosumab Treatment

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital, Yunlin branch

Douliu, Yunlin County, 640, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Zoledronate

Drug

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

Other names: Zoledronic acid

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).

Primary outcomes

  1. Bone mineral density of lumbar spine

    Time frame: one year

    Bone mineral density of lumbar spine

Secondary outcomes

  1. Bone mineral density of femoral neck

    Time frame: one year

    Bone mineral density of femoral neck

  2. Bone mineral density of total hip

    Time frame: one year

    Bone mineral density of total hip

  3. bone turnover markers

    Time frame: 13 months

    Changes of C-terminal telopeptide of type I collagen (CTX) and propeptide of procollagen type I (P1NP)

  4. clinical osteoporotic fracture

    Time frame: 1 year

    any incidence of clinical osteoporotic fracture

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2021
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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