Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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. Seventy-two 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. In addition, as Tymlos is now approved for treatment in men, the investigators will enroll 24 men aged 55 and over who will treat in an open-label design. Their responses to teriparatide will be compared to those of untreated men in an ongoing observational study, as well as to the postmenopausal women. This study has 3 objectives:
All analyses will be two-sided and the alpha level will be set at 0.05. FBMV, pain and function will be compared by drug (Abaloparatide vs. placebo) at 6 months. Compliance will be considered as taking 80% of the study drug. For the primary analysis the investigators will evaluate bone union and reduced pedicle screw loosening, adjacent segment fracture, and proximal junctional kyphosis as dichotomous variables at 12 months using logistic regression and comparing the placebo group to the abaloparatide group. The investigators will also evaluate FBMV as a continuous variable and evaluate differences in this outcome between abaloparatide and placebo groups at 6 months as an exploratory outcome variable. The investigators will determine if FBMV differs in those with or without markers of surgical success for validity of FBMV, regardless of prior treatment group. In addition, these data will be used to determine effect sizes and variance to power the next larger clinical trial.
The investigators will evaluate NRS and ODI score by using repeated measures of these variables over time by treatment group and evaluate NRS at 6 months in the placebo versus abaloparatide group. Comorbidity, age, prior fracture, prior use of bisphosphonates and other covariates will be evaluated, via multivariable regression, as to whether they lead to a change in the estimate of effect in order to be considered for inclusion in the models.
If abaloparatide can improve outcomes following lumbar spine fusion surgery, this pilot study could lead to the requisite two year trial that may have an impact on the treatment of fusion surgery patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abaloparatide (PM Women) | Active Comparator | Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months |
|
| Placebo (PM Women) | Placebo Comparator | Placebo administered subcutaneously with a pen once daily for 6 months |
|
| Abaloparatide (Men) | Experimental | Open-label treatment with Abaloparatide 80 mcg dose administered subcutaneously with a pen once daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abaloparatide | Drug | 80 mcg delivered SC by a pen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessed by the Numeric Rating Scale | Numeric Rating Scale (NRS) from 0 to 10 with higher scores indicating more pain. | 6 months |
| Pain assessed by the Oswestry Disability Index | Oswestry Disability Index for low back pain with a score of 0 to 50 points or 0 to 100%. Higher scores indicate more pain. |
| Measure | Description | Time Frame |
|---|---|---|
| CT evaluation of Fusion bone mass volume | fusion bone mass volume (FBMV) as a marker of bone union will be assessed on CT images | 6 months and 1 year |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emily Stein, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596789 | abaloparatide |
Not provided
Not provided
Not provided
Randomized controlled trial (PM women) Open-label treatment study (Men)
Not provided
Not provided
Placebo will be used that will be identical to active drug in appearance (PM women)
| Placebo | Drug | A pen to deliver a SC dose of placebo |
|
|
| 6 months |