Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05655013 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2)

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Feb 1, 2025 to Feb 1, 2027 Trial status: Recruiting to Active, Not Recruiting · Site details revisedv6 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
  2. Eligibility criteria revised Study title expanded, about 1 wordv5 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria revised Secondary endpoints: details revised at 1 of 10 entriesv4 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 10 entries

    See this version in full on ClinicalTrials.gov ↗

  4. Eligibility criteria expanded, about 65 words Secondary endpoints: details revised at 1 of 10 entriesv3 Show 1 more changeShow less
    • Secondary endpoints: details revised at 1 of 10 entries

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 1, 2023 to May 10, 2023 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 1, 2023 to May 10, 2023
    • Study sites: 0 to 1
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aims of ZOLARMAB2 are fourfold. First, the investigators want to investigate if multiple infusions of zoledronate can prevent the rebound activation of bone turnover and the subsequent bone loss in patients previously treated with denosumab and if there is difference between infusing zoledronate at fixed time-points after the last injection of denosumab or when bone turnover is increased. Second, the investigators want to investigate if bone loss will resume after controlling the rebound activation of bone turnover during the first year after denosumab discontinuation and if this can be prevented by yearly infusions of zoledronate. Third, the investigators want to investigate the underlying pathophysiological mechanisms by investigating biochemical markers, osteoclast and osteoblast activation signals in the bone and bone marrow, and the pool of preosteoclasts/mature osteoclasts before and after treatment with zoledronate. Fourth, the investigators want to investigate the effect of denosumab discontinuation on muscle mass and muscle strength and on insulin sensitivity.
Trial Details
NCT Number NCT05655013
Lead Sponsor Aarhus University Hospital
Conditions Osteoporosis, Postmenopausal
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov