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)

Radius Health

Status and phase

Completed

Phase 1

Conditions

Postmenopausal Osteoporosis

Treatments

Combination Product: abaloparatide-sMTS

Study type

Interventional

Funder types

Industry

Identifiers

NCT04366726

BA058-05-022

Details and patient eligibility

About

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

Full description

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.

Enrollment

22 patients

Sex

Female

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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