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Completed

NCT Number: NCT04366726

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)

This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

50 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaceutical Research Associates, Inc

Lenexa, Kansas, 66219, United States

About this study

This study aimed to evaluate the ability of participants to self-administer 300 μg abaloparatide-sMTS over a period of 29 days based on PK and PD markers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal for at least 2 years
  • BMD T-score based on the female reference range <-1.0 and >-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

Treatment and study plan

abaloparatide-sMTS

Combination Product

Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.

Primary outcomes

  1. Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29

    Time frame: 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29

  2. Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29

    Time frame: 0 (predose) and 4 hours postdose on Day 29

Secondary outcomes

  1. Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at Day 29

    Time frame: Baseline, Day 29

    Blood samples were taken to measure s-PINP, a bone formation marker. s-PINP concentrations reflect the rate of skeletal new bone formation. Increases in s-PINP indicate anabolic biologic response in the bone.

  2. Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29

    Time frame: Baseline, 0 (predose) and 4 hours postdose on Day 29

  3. Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29

    Time frame: Baseline, 0 (predose) and 4 hours postdose on Day 29

  4. Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29

    Time frame: Baseline, 0 (predose) and 30-minutes postdose on Day 29

Sponsors and collaborators

Lead sponsor

Radius Health, Inc.

Industry

Registry information

Official study title

A Prospective, Single Arm Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2020
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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