RECRUITING

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

Talk to us

Conditions

Spinal Fusionabalopartidepainsurgical outcome

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-08-14
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03841058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Postmenopausal women (defined as \>12 months since last menstrual cycle) OR men
  2. * Age of 50 years or older
  3. * 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.
  1. 1. Hypersensitivity to abaloparatide
  2. 2. Patients with increased risk of osteosarcoma: Paget's disease, prior radiation therapy
  3. 3. Patients with active hypercalcemia or current diagnosis of hyperparathyroidism
  4. 4. History of multiple renal calculi or renal calculus within 2 years
  5. 5. Unexplained elevations in alkaline phosphatase
  6. 6. Evidence of metastatic cancer or multiple myeloma.
  7. 7. Patients unwilling to take placebo or abaloparatide.
  8. 8. Patients whose surgery is for a revision to a prior lumbar spinal fusion surgery
  9. 9. Chronic oral steroids (\>= 7.5 mg prednisone/d currently and for more than 1 month) for an inflammatory comorbid diagnosis
  10. 10. Patients who cannot understand and sign the informed consent
  11. 11. Patients who are unable to meet the proposed follow-up schedule
  12. 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. 13. Patients who have received bisphosphonate treatment of \>1 year in past 5 years
  14. 14. Patients who are current smokers

Contacts and Locations

Study Contact

Giavanna D'Erasmo
CONTACT
(646) 797-8797
derasmogi@hss.edu

Principal Investigator

Emily Stein, MD
PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York

Study Locations (Sites)

Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

  • Emily Stein, MD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-14
Study Completion Date2026-09

Study Record Updates

Study Start Date2019-08-14
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • abalopartide
  • pain
  • surgical outcome

Additional Relevant MeSH Terms

  • Spinal Fusion