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RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 54 to 66
    • Eligibility criteria shortened, about 82 words
    • Secondary endpoints: 2 to 1
    v14
  2. 2 versions Re-verified since Jan 29, 2025, no change to tracked fieldsv12-v13
  3. Site details revised at 2 of 54 sitesv11
  4. Study sites: 51 to 54v10
  5. Study sites: 50 to 51
    • Collaborators: 5 to 4
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Collaborators: 4 to 5
    • Study description expanded, about 3 words
    v8
  2. Study sites: 25 to 50
    • Eligibility criteria expanded, about 18 words
    v7
  3. Study title expanded, about 2 wordsv6
  4. Study sites: 5 to 25
    • Eligibility criteria revised
    v5
  5. Study Status, Referencesv4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Apr 30, 2021 to Apr 24, 2021
    v3
  7. Start date: Apr 1, 2021 to Apr 30, 2021v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.
Trial Details
NCT Number NCT04796350
Lead Sponsor AgNovos Healthcare, LLC
Collaborators: Avania, CMIC Co, Ltd. Japan, BioClinica, Inc., Emergent Clinical Consulting, LLC
Conditions
(from sponsor)		 Fragility Fracture, Hip Fractures, Osteoporosis
Related terms Hip Fractures, Osteoporosis
Enrollment 2,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov