Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
Richard S. Bockman, MD, PhD
Douglas N. Mintz, MD
Frank J. Schwab, MD
Han Jo Kim, MD
Linda A, Russell,MD
Joseph M .Lane, MD
Matthew E.Cunningham, MD, PhD
Jeri Nieves, Ph.D
Ryan E. Breighner
Carey Ford
Daniela Tinca
Jonathan Harrison
Donald J. McMahon
Tariq Chukir
Alexander Dash
John A. Carrino
Caroline Zaworski
Alexander Gilman
Alexandra Krez
We will be enrolling 72 patients, of which 48 will receive Abaloparatide for 12 months and 24 will receive placebo for the first 6 months and Abaloparatide for the remaining 6 months.
The study includes 4 study visits to HSS (Screening/Baseline/Week 0, 6 weeks, 6 months, and 12 months) and follow-up phone calls. Blood draws for the study must be done fasting (no food or drink other than water) before 10 AM.
Inclusion Criteria:
All postmenopausal women (defined as >12 months since last menstrual cycle) requiring surgery.
Eligible subjects will be patients, over the age of 50, undergoing lumbar spine fusion surgery (L1-2; L2-3; L3-4; L4-5) requiring 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:
a) Hypersensitivity to abaloparatide
b) Patients with history of Paget’s disease or prior radiation therapy
c) Patients with active hypercalcemia (increased calcium in the blood) or current diagnosis of hyperparathyroidism
d) History of multiple kidney stones or kidney stone within 2 years
e) Unexplained elevations in alkaline phosphatase (if alkaline phosphatase is above the upper limit of normal, bone specific alkaline phosphatase will be checked, if normal patients can be enrolled. If not, they will be excluded)
f) Evidence of metastatic cancer or multiple myeloma.
g) Patients unwilling to take placebo or abaloparatide.
h) Patients who have had lumbar spinal fusion surgery previously
i) Chronic oral steroids currently and for more than 1 month (>= 7.5 mg prednisone/d or equivalent) for an autoimmune disease
j) Patients who cannot understand and sign the informed consent
k) Patients who are unable to meet the proposed follow-up schedule
l) Patients with >1 year of prior treatment with Forteo and/or Tymlos or any use of Forteo or Tymlos within the 6 months prior to enrollment.
m) Patients who have received bisphosphonate treatment of >1 year in past 5 years and no bisphosphonates in the past 2 years
n) Current smokers
Caroline Zaworski, Study Coordinator
zaworskic@hss.edu
646.797.8797