Phase 1
N=22
Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)
Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT04366726 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29 — 399.6 picograms/milliliter (pg/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- abaloparatide-sMTS (Combination_product)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Female
- Sponsor
- Radius Health, Inc.
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29 |
399.6 | — |
| PRIMARY Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29 |
604.7 | — |
| SECONDARY Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29 |
103.16 | — |
| SECONDARY Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29 |
-0.031; -0.002 | — |
| SECONDARY Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29 |
0.051; 0.006 | — |
| SECONDARY Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29 |
-0.0030; -0.0006 | — |
Summary
This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal for at least 2 years
- BMD T-score based on the female reference range -5.0 at the lumbar spine (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA)
- Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index up to 33 kilograms/square meter (kg/m^2)
- Laboratory tests within the normal range including serum calcium (albumin-corrected), intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone
- Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL)
Exclusion Criteria
- History of prior external beam or implant radiation therapy involving the skeleton, other than radioiodine
- History of bone disorders other than postmenopausal osteoporosis (such as Paget's disease)
- History of cancer within the last 5 years (with the exception of basal cell or squamous cancer of the skin)
- History of Cushing's disease, hypo or hyperparathyroidism, or malabsorptive syndromes within the past year
- Prior treatment with PTH, PTH-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or PTH (1-84)
- Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past year (12 months). Participants who have received a short course of oral bisphosphonate therapy (3 months or less) may be enrolled as long as the treatment occurred 6 or more months prior to enrollment
- Prior treatment with an investigational drug or device within the past 3 months or 5 half-lives of the investigational drug, whichever is longer
Data sourced from ClinicalTrials.gov (NCT04366726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.