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

NCT03841058 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2018-0287
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Fusion

Keywords

abalopartide; pain; surgical outcome

Outcome Measures

Primary Outcomes (2)

• Difference in measure of fusion mass bridging from transverse process to transverse process

  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)

  one year

• Difference in incidence of adverse surgical outcomes

  Adverse outcomes include pedicle screw loosening, adjacent segment fracture and proximal junctional kyphosis will be evaluated on CT images

  one year

Secondary Outcomes (2)

• Pain assessed by the Numeric Rating Scale

  6 months

• Pain assessed by the Oswestry Disability Index

  6 months

Other Outcomes (1)

• CT evaluation of Fusion bone mass volume

  6 months and 1 year

Study Arms (3)

Abaloparatide (PM Women)

ACTIVE COMPARATOR

Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months

Drug: Abaloparatide

Placebo (PM Women)

PLACEBO COMPARATOR

Placebo administered subcutaneously with a pen once daily for 6 months

Drug: Placebo

Abaloparatide (Men)

EXPERIMENTAL

Open-label treatment with Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months

Drug: Abaloparatide

Interventions

Abaloparatide DRUG

80 mcg delivered SC by a pen

Also known as: Tymlos

Abaloparatide (Men); Abaloparatide (PM Women)

Placebo DRUG

A pen to deliver a SC dose of placebo

Also known as: placebo pen

Placebo (PM Women)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Hypersensitivity to abaloparatide
• Patients with increased risk of osteosarcoma: Paget's disease, prior radiation therapy
• Patients with active hypercalcemia or current diagnosis of hyperparathyroidism
• History of multiple renal calculi or renal calculus within 2 years
• Unexplained elevations in alkaline phosphatase
• Evidence of metastatic cancer or multiple myeloma.
• Patients unwilling to take placebo or abaloparatide.
• Patients whose surgery is for a revision to a prior lumbar spinal fusion surgery
• Chronic oral steroids (\>= 7.5 mg prednisone/d currently and for more than 1 month) for an inflammatory comorbid diagnosis
• Patients who cannot understand and sign the informed consent
• Patients who are unable to meet the proposed follow-up schedule
• 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.
• Patients who have received bisphosphonate treatment of \>1 year in past 5 years
• Patients who are current smokers

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Pain

Interventions

abaloparatide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emily Stein, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo will be used that will be identical to active drug in appearance (PM women)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial (PM women) Open-label treatment study (Men)

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 15, 2019
• Study Start: August 14, 2019
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)