The Optimal Sequential Therapy After Long Term Denosumab Treatment

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    44
  • sponsor
    National Taiwan University Hospital
Updated on 2 November 2021
denosumab
alendronate
zoledronate

Summary

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

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.

Details
Condition Osteoporosis, Osteopenia
Treatment Alendronate
Clinical Study IdentifierNCT05091099
SponsorNational Taiwan University Hospital
Last Modified on2 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Postmenopausal women or men over 50 years old
Denosumab treatment for at least two years and less than three years (up to five doses)

Exclusion Criteria

Estimated glomerular filtration rate <35 ml/min
Malignancy
Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism
Secondary osteoporosis
Metabolic bone diseases
Contraindications to ZOL
Patients older than 80 years old
Hypocalcemia
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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