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Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery

Study acronym: FAST-Healing
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 3 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Sep 2026 to Feb 2027
    • Site details revised
    v16
  3. Site contact updatedv15
  4. Study description expanded, about 7 wordsv14
  5. Primary and study completion dates: Oct 2024 to Sep 2026v13 Show 6 more changesShow less
    • Enrollment target: 72 to 96
    • Study description expanded, about 51 words
    • Site contact updated
    • Study title revised
    • Study arms: 2 to 3
    • Eligibility criteria expanded, about 2 words
Show 11 earlier versionsHide 11 earlier versions
  1. Primary and study completion dates: Jan 2024 to Oct 2024v12
  2. 2 versions Re-verified since Mar 29, 2023, no change to tracked fieldsv10-v11
  3. Primary and study completion dates: Sep 2021 to Jan 2024
    • Site contact updated
    v9
  4. Start date: Dec 19, 2018 to Aug 14, 2019v8
  5. Trial status: Suspended to Recruiting
    • Site details revised
    • Eligibility criteria shortened, about 2 words
    v7
  6. Trial status: Recruiting to Suspended Sponsor's reason: Due to COVID-19.
    • Site details revised
    • Study title expanded, about 4 words
    v6
  7. Eligibility criteria shortened, about 47 wordsv5
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 2019 to Dec 19, 2018
    v4
  9. Study description expanded, about 47 words
    • Eligibility criteria expanded, about 2 words
    v3
  10. Start date: May 2019 to Sep 2019
    • Primary and study completion dates: May 2021 to Sep 2021
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective randomized, double-blinded, placebo-controlled, phase 2, 12-month pilot to study the efficacy of abaloparatide in postmenopausal women needing lumbar spinal fusion surgery. A total of 72 women with low bone mass who are scheduled to undergo spinal fusion surgery will be randomized 2:1 in a blinded fashion to receive either 80 mcg of abaloparatide subcutaneously (SC) every day or an identical-appearing placebo SC for 6 months. As well as a total of 24 men in an open-label design will be enrolled as an extension to this study. The total anticipated enrollment updated to 97. Outcomes include surgical outcomes at one year, pain, and fusion bone mass volume (FBMV) as a marker of bone union at 6 months and 1 year.
Trial Details
NCT Number NCT03841058
Lead Sponsor Hospital for Special Surgery, New York
Conditions
(from sponsor)		 Spinal Fusion
Related terms Pain
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov