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NCT Number: NCT05091086

The Optimal Long Term Treatment Strategy of Anti-resorptive Medications

This study is to investigate whether the alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid) can continue to increase bone density.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

50 year–80 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 the long-term treatment of Denosumab and Zoledronic acid can achieve sustained bone density progress and 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 with osteoporosis or osteopenia leading to fractures.
  • Denosumab treatment for at least two years and less than three years (up to maximum of five doses).

Exclusion criteria

  • Secondary osteoporosis.
  • Metabolic bone diseases.
  • Malignancy.
  • Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism.
  • Patients had ever used antiosteoporosis medications other than Dmab
  • Estimated glomerular filtration rate < 35 mL/min.
  • Allergy to Zoledronate.
  • Any other contraindications to Zoledronate use.
  • History of diagnosed hypocalcemia.
  • Age greater than 80 years.

Treatment and study plan

Continuous Denosumab

Drug

Active comparator: persistent treatment of denosumab.

Administer zoledronate and denosumab on an alternating schedule

Drug

In the experimental group, zoledronic acid was administered for one year, followed by two years of denosumab. This cycle was repeated, with the regimen concluding with one year of zoledronic acid.

Primary outcomes

  1. Change in lumbar spine bone mineral density

    Time frame: From enrollment to the end of treatment at 3 years

Secondary outcomes

  1. Change in total hip bone mineral density

    Time frame: From enrollment to the end of treatment at 3 years and 7 years

  2. Change in femoral neck bone mineral density

    Time frame: From enrollment to the end of treatment at 3 years and 7 years

  3. Change in lumbar spine bone mineral density

    Time frame: From enrollment to the end of treatment at 7 years

  4. Change in C-terminal telopeptide of type 1 collagen

    Time frame: From enrollment to the end of treatment at 3 years and 7 years

  5. Change in Procollagen type 1 N-terminal propeptide

    Time frame: From enrollment to the end of treatment at 3 years and 7 years

  6. Fractures

    Time frame: 3 & 7 years

    Number of Participants with clinical fractures and radiographic vertebral fractures

  7. Change in quality of life

    Time frame: From enrollment to the end of treatment at 3 years and 7 years

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Oct 25, 2021
Registry last updated
May 22, 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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