Status:
COMPLETED
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)
Lead Sponsor:
Radius Health, Inc.
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
50-85 years
Phase:
PHASE1
Brief Summary
This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04366726
Start Date
April 9 2019
End Date
May 14 2019
Last Update
November 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pharmaceutical Research Associates, Inc
Lenexa, Kansas, United States, 66219