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NCT04366726·Phase 1·INTERVENTIONAL

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)

Status

Completed

Phase

Phase 1

Enrollment

22

Locations

1

Results

Posted

Publications

1

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

COMBINATION_PRODUCT

abaloparatide-sMTS

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

Timeline

From registration to results.

  1. First posted

    Apr 29, 2020

  2. Study start

    Apr 9, 2019

  3. Primary completion

    May 14, 2019

  4. Study completion

    May 14, 2019

  5. Results posted

    Nov 22, 2023

  6. Registry updated

    Nov 22, 2023

Outcomes

What the study measures.

Primary outcomes

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

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

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.

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

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

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

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

Eligibility

Who can take part.

Minimum age
50 Years
Maximum age
85 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Pharmaceutical Research Associates, Inc

Lenexa, Kansas, United States

Related trials

More studies on Abaloparatide.

Related PeptideStat pages

Put the record in context.

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