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This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS by participants with low BMD.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abaloparatide-sMTS | Experimental | Abaloparatide-sMTS 300 micrograms (μg) was applied to the thigh for 5 minutes once daily for 29 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29 | 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 | 0 (predose) and 4 hours postdose on Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at 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. | Baseline, Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Radius Health, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc | Lenexa | Kansas | 66219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33638863 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Abaloparatide-sMTS | Abaloparatide-solid microstructured transdermal system (sMTS) 300 micrograms (μg) was applied to the thigh for 5 minutes once daily for 29 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2019 | Dec 27, 2022 |
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| Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29 |
| Baseline, 0 (predose) and 4 hours postdose on Day 29 |
| Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29 | Baseline, 0 (predose) and 4 hours postdose on Day 29 |
| Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29 | Baseline, 0 (predose) and 30-minutes postdose on Day 29 |
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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The Safety Population included all participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abaloparatide-sMTS | Abaloparatide-sMTS 300 μg was applied to the thigh for 5 minutes once daily for 29 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Abaloparatide Maximum Plasma Concentration (Cmax) on Day 29 | The Pharmacokinetic Analysis Population included all participants who received at least 1 dose of study drug and who had sufficient evaluable plasma concentrations to reliably estimate 1 or more PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms/milliliter (pg/mL) | 0 (predose), 10 minutes, 20 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, and 4 hours postdose on Day 29 |
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| Primary | Abaloparatide Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) on Day 29 | The Pharmacokinetic Analysis Population included all participants who received at least 1 dose of study drug and had sufficient evaluable plasma concentrations to reliably estimate 1 or more PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*pg/mL | 0 (predose) and 4 hours postdose on Day 29 |
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| Secondary | Percent Change From Baseline of Serum Procollagen Type I N-Terminal Propeptides (s-PINP) at 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. | The Bone Metabolism Population includes all participants in the Safety Population who have baseline and at least one post-baseline s-PINP. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 29 |
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| Secondary | Change From Baseline of Serum Calcium (Albumin-Corrected) to Predose and Postdose on Day 29 | The Safety Population included all participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | millimoles/liter (mmol/L) | Baseline, 0 (predose) and 4 hours postdose on Day 29 |
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| Secondary | Change From Baseline of Serum Phosphorus to Predose and Postdose on Day 29 | The Safety Population includes all participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | mmol/L | Baseline, 0 (predose) and 4 hours postdose on Day 29 |
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| Secondary | Change From Baseline of Cyclic Adenosine Monophosphate (cAMP) to Day 29 | The Safety Population included all participants who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | micromoles/liter (μmol/L) | Baseline, 0 (predose) and 30-minutes postdose on Day 29 |
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Day 1 up to Day 36
The Safety Population included all participants who received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abaloparatide-sMTS | Abaloparatide-sMTS was applied to the thigh for 5 minutes once daily for 29 days. | 0 | 22 | 0 | 22 | 22 | 22 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site erythema | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Application site haemorrhage | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Application site oedema | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Application site pain | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Application site swelling | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Burning sensation | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
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Results may not be published prior to the Study Report completion. Investigators may publish results, providing a manuscript to the Sponsor =/> 30 days prior to its submission to a publisher. Sponsor will provide manuscript to Investigators =/> 30 days prior to its submission. Investigator shall comply with Sponsor's policy, withholding publication for an additional 60 days to permit the Sponsor to obtain patent or other proprietary rights protection, if deemed necessary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Operations | Radius Health, Inc. | (617) 551-4000 | info@radiuspharm.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 19, 2019 | Dec 27, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories |
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| Day 29, predose |
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| Day 29, postdose |
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| Title |
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| Denominators |
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| Categories |
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| Day 29, predose |
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| Day 29, postdose |
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| Title | Denominators | Categories |
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| Day 29, predose |
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| Day 29, postdose |
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