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Study to Evaluate the PK, PD and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density

Primary Purpose

Postmenopausal Osteoporosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

abaloparatide-sMTS

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis focused on measuring postmenopausal osteoporosis, transdermal delivery, microneedle patch, abaloparatide

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Healthy ambulatory female from 50 to 85 years of age (inclusive)
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).

Every effort was made to enroll subjects with a T-score of -2.0 or lower but > -5.0

Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index up to 33 kg/m^2
Laboratory tests within the normal range including serum calcium (albumin-corrected), PTH(1-84), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone
Serum 25-hydroxyvitamin D values must be ≥ 20 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)
Diagnosis 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 hyper-parathyroidism or malabsorptive syndromes within the past year
Prior treatment with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84)
Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past year (12 months). Subjects 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

Sites / Locations

Pharmaceutical Research Associates, Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

abaloparatide-sMTS

Arm Description

Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide, which is an active synthetic peptide of parathyroid hormone, coated onto a sMTS array for transdermal administration of abaloparatide.

Outcomes

Primary Outcome Measures

PK Cmax

Abaloparatide Maximum Plasma Concentration (Cmax) on Day 1, 15, and 29

PK AUC

Abaloparatide Area Under the Plasma Concentration Curve (AUC) on Day 1, 15, and 29

Secondary Outcome Measures

PD Percent change of s-PINP

Percent change of s-PINP from baseline to Day 15 and Day 29.

PD Change in serum calcium

Change in serum calcium (albumin-corrected) from baseline to each post-dose timepoint.

PD Change in serum phosphorus

Change in serum phosphorus from baseline to each post-dose timepoint.

PD Change in cAMP

Change in cAMP from baseline to each post-dose timepoint.

PD percent change in serum calcium

Percent change in serum calcium (albumin-corrected) from baseline to each post-dose timepoint.

PD percent change in serum phosphorus

Percent change in serum phosphorus from baseline to each post-dose timepoint.

PD percent change in cAMP

Percent change in cAMP from baseline to each post-dose timepoint

Full Information

NCT ID

NCT04366726

First Posted

April 16, 2020

Last Updated

May 28, 2020

Sponsor

Radius Health, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04366726

Brief Title

Study to Evaluate the PK, PD and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 9, 2019 (Actual)

Primary Completion Date

May 14, 2019 (Actual)

Study Completion Date

June 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radius Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

A 29 days study to evaluate the usability of the abaloparatide-sMTS

Detailed Description

This study aims to evaluate the ability of subjects to self-administer 300 μg abaloparatide-sMTS over a period of 29 days based on pharmacokinetic (PK) and pharmacodynamic (PD) markers

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal Osteoporosis

Keywords

postmenopausal osteoporosis, transdermal delivery, microneedle patch, abaloparatide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

All subjects applied a transdermal patch containing 300 μg abaloparatide for 5 minutes daily for 29 days

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

abaloparatide-sMTS

Arm Type

Experimental

Arm Description

Intervention Type

Combination Product

Intervention Name(s)

abaloparatide-sMTS

Intervention Description

abaloparatide 300 μg applied to the thigh for 5 minutes once daily for 29 days

Primary Outcome Measure Information:

Title

PK Cmax

Description

Abaloparatide Maximum Plasma Concentration (Cmax) on Day 1, 15, and 29

Time Frame

29 days

Title

PK AUC

Description

Abaloparatide Area Under the Plasma Concentration Curve (AUC) on Day 1, 15, and 29

Time Frame

29 days

Secondary Outcome Measure Information:

Title

PD Percent change of s-PINP

Description

Percent change of s-PINP from baseline to Day 15 and Day 29.

Time Frame

29 Days

Title

PD Change in serum calcium

Description

Change in serum calcium (albumin-corrected) from baseline to each post-dose timepoint.

Time Frame

29 Days

Title

PD Change in serum phosphorus

Description

Change in serum phosphorus from baseline to each post-dose timepoint.

Time Frame

29 Days

Title

PD Change in cAMP

Description

Change in cAMP from baseline to each post-dose timepoint.

Time Frame

29 Days

Title

PD percent change in serum calcium

Description

Percent change in serum calcium (albumin-corrected) from baseline to each post-dose timepoint.

Time Frame

29 days

Title

PD percent change in serum phosphorus

Description

Percent change in serum phosphorus from baseline to each post-dose timepoint.

Time Frame

29 days

Title

PD percent change in cAMP

Description

Percent change in cAMP from baseline to each post-dose timepoint

Time Frame

29 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy ambulatory female from 50 to 85 years of age (inclusive) 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). Every effort was made to enroll subjects with a T-score of -2.0 or lower but > -5.0 Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index up to 33 kg/m^2 Laboratory tests within the normal range including serum calcium (albumin-corrected), PTH(1-84), serum phosphorus, alkaline phosphatase, and thyroid stimulating hormone Serum 25-hydroxyvitamin D values must be ≥ 20 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) Diagnosis 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 hyper-parathyroidism or malabsorptive syndromes within the past year Prior treatment with parathyroid hormone, parathyroid hormone-related peptide-derived drugs, or bone anabolic steroids, including abaloparatide, teriparatide, or parathyroid hormone (1-84) Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates within the past year (12 months). Subjects 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

Facility Information:

Facility Name

Pharmaceutical Research Associates, Inc

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

33638863

Citation

Miller PD, Troy S, Weiss RJ, Annett M, Schense J, Williams SA, Mitlak B. Phase 1b Evaluation of Abaloparatide Solid Microstructured Transdermal System (Abaloparatide-sMTS) in Postmenopausal Women with Low Bone Mineral Density. Clin Drug Investig. 2021 Mar;41(3):277-285. doi: 10.1007/s40261-021-01008-7. Epub 2021 Feb 27.

Results Reference

derived

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Study to Evaluate the PK, PD and Usability of Abaloparatide-sMTS in Postmenopausal Women With Low Bone Mineral Density

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