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

Short name FAST-Healing

NCTNCT03841058Other id2018-0287

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Active, not recruiting
Phase: Phase 2
Enrollment: 96 participants (estimated)
Sponsor: Hospital for Special Surgery, New York · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 14 Aug 2019
Primary completion: Feb 2027 (estimated)
Completion: Feb 2027 (estimated)
First posted: 15 Feb 2019
Last update posted: 28 Sept 2026
Conditions: Spinal Fusion

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20202022202420262028

Ph 2
FAST-Healing
NCT03841058
14 Aug 2019 to est. Feb 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

AbaloparatideDrug
PlaceboDrug

Arms3

Active comparator
Abaloparatide (PM Women)
Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months
Placebo comparator
Placebo (PM Women)
Placebo administered subcutaneously with a pen once daily for 6 months
Experimental
Abaloparatide (Men)
Open-label treatment with Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months

Primary outcomes2

Outcomes the sponsor listed as primary.

Difference in measure of fusion mass bridging from transverse process to transverse process
Time frame · one year
Registry description
CT assessment of fusion mass using a qualitative five-point scale to assess fusion quality (1 = unfused, 2 = partial unilateral fusion, 3 = partial bilateral fusion, 4 = complete unilateral fusion, 5 = complete bilateral fusion)
Difference in incidence of adverse surgical outcomes
Time frame · one year
Registry description
Adverse outcomes include pedicle screw loosening, adjacent segment fracture and proximal junctional kyphosis will be evaluated on CT images

Secondary outcomes(2)

Pain assessed by the Numeric Rating Scale
Time frame · 6 months
Registry description
Numeric Rating Scale (NRS) from 0 to 10 with higher scores indicating more pain.
Pain assessed by the Oswestry Disability Index
Time frame · 6 months
Registry description
Oswestry Disability Index for low back pain with a score of 0 to 50 points or 0 to 100%. Higher scores indicate more pain.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Postmenopausal women (defined as \>12 months since last menstrual cycle) OR men * Age of 50 years or older * Requiring posterolateral lumbar spine fusion surgery (L1-2; L2-3; L3-4; L4-5, L5-S1) with single or multi-level fusion for degenerative conditions of the lumbar spine (including lumbar degenerative disk disease, severe instability, high grade spondylolisthesis, deformity, degenerative scoliosis, pseudoarthrosis, and spinal stenosis) under the care of spine surgeons at the Hospital for Special Surgery. Exclusion Criteria: 1. Hypersensitivity to abaloparatide 2. Patients with increased risk of osteosarcoma: Paget's disease, prior radiation therapy 3. Patients with active hypercalcemia or current diagnosis of hyperparathyroidism 4. History of multiple renal calculi or renal calculus within 2 years 5. Unexplained elevations in alkaline phosphatase 6. Evidence of metastatic cancer or multiple myeloma. 7. Patients unwilling to take placebo or abaloparatide. 8. Patients whose surgery is for a revision to a prior lumbar spinal fusion surgery 9. Chronic oral steroids (\>= 7.5 mg prednisone/d currently and for more than 1 month) for an inflammatory comorbid diagnosis 10. Patients who cannot understand and sign the informed consent 11. Patients who are unable to meet the proposed follow-up schedule 12. Patients with \>1 year of prior cumulative treatment with Forteo and/or Tymlos, or any use of Forteo or Tymlos within the 6 months prior to enrollment. 13. Patients who have received bisphosphonate treatment of \>1 year in past 5 years 14. Patients who are current smokers

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