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Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 23, 2024 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment target: 66 to 48
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints revised (27)
    • Site contacts updated at 1 of 4 sites
    v5
  2. Primary completion date: Feb 1, 2024 to Sep 1, 2026v4 Show 6 more changesShow less
    • Study sites: 3 to 4
    • Study completion date: Feb 1, 2025 to Sep 1, 2027
    • Interventions: Blood samples and physical examination (Other), Bone biopsy (Procedure), Cardiac tests (Diagnostic Test), Circadian variation (Other), Dual… to Blood and urine samples and physical examination (Other), Bone biopsy (Procedure), Cardiac tests (Diagnostic Test), DXA,VFA, X-ray…
    • Eligibility criteria expanded, about 49 words
    • Secondary endpoints: 29 to 27
    • Collaborators revised (4)
  3. Start date changed from estimate of May 2021 to Dec 15, 2021
    • Eligibility criteria shortened, about 20 words
    v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Sep 2020 to May 2021
    • Primary completion date: Mar 2024 to Feb 1, 2024
    • Study completion date: Mar 2025 to Feb 1, 2025
    • Site details revised at 3 of 3 sites
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study is a 1:1 randomized controlled trial with an intervention for 18 months and a follow up period of 12 months. The purpose of the study is to assess the safety and efficacy of recombinant human parathyroid hormone for treatment of adynamic bone disorder in patients with chronic kidney disease.
Trial Details
NCT Number NCT04522622
Lead Sponsor Ditte Hansen
Collaborators: Odense University Hospital, Steno Diabetes Center Copenhagen, Rigshospitalet, Denmark, Aalborg University Hospital
Conditions
(from sponsor)		 Adynamic Bone Disease, Chronic Kidney Diseases, Cardiac Disease, Chronic Kidney Disease-Mineral and Bone Disorder
Related terms Chronic Kidney Disease-Mineral and Bone Disorder, Heart Diseases, Renal Insufficiency, Chronic
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov