OsteoporosisPhase 1NCT04936984
Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.
A Phase 1 study testing abaloparatide-sMTS (Patheon) and abaloparatide-sMTS (Kindeva) in people with Osteoporosis, run by Radius Health, Inc. at 1 site in United States.
Trial summary
A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- abaloparatide-sMTS (Patheon) and abaloparatide-sMTS (Kindeva)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2020to 13 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female subjects aged 40 to 65 years old, inclusive, at Screening
- Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 34 kg/m^2 inclusive)
- Laboratory tests within the normal range
- Serum 25-hydroxyvitamin D values must be > 20 ng/mL
Who cannot join
- Presence or history of any disorder that may prevent the successful completion of the study.
- Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening;
- History of any cancer within the past 5 years other than squamous or basal cell carcinoma;
- History of allergy to abaloparatide or drugs in a similar pharmacological class;
Trial locations and contacts
1 site in 1 country.
United States1 site
Medpace Clinical Pharmacology
Cincinnati, Ohio, 45227
About this study
Official title: An Open-Label, Randomized, 4-Period Crossover Study Evaluating the Bioequivalence of Two Abaloparatide-sMTS Treatments and the Effect of Small Variations in Wear-Time in Healthy Women.
A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.
Read the detailed description
This is a single site, open-label, randomized, 4-period crossover study to evaluate the bioequivalence of 2 abaloparatide-sMTS 300 μg treatments (Patheon sterile abaloparatide-sMTS and Kindeva ultra-low bioburden abaloparatide-sMTS) applied to the thigh for 5 minutes. The study will also evaluate the effect of small deviations in the wear-time of the Patheon abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS worn for the prescribed 5 minutes.
- Conditions
- Osteoporosis
- Being tested
- abaloparatide-sMTS (Patheon), abaloparatide-sMTS (Kindeva)
- Keywords
- osteoporosis, transdermal delivery, microneedle patch, solid microstructured transdermal system, abaloparatide TYMLOS®, abaloparatide-SC, PK
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abaloparatide-sMTS (Patheon)Combination product
Also called abaloparatide-sMTS
single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
abaloparatide-sMTS (Kindeva)Combination product
Also called abaloparatide-sMTS
single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
abaloparatide-sMTS (Patheon)Combination product
Also called abaloparatide-sMTS
single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes
abaloparatide-sMTS (Patheon)Combination product
Also called abaloparatide-sMTS
single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes
| Study group | Role | What they receive |
|---|---|---|
| Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min | Experimental | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). Receives: Combination Product: abaloparatide-sMTS (Patheon); Combination Product: abaloparatide-sMTS (Kindeva) |
| Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min | Experimental | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). Receives: Combination Product: abaloparatide-sMTS (Patheon); Combination Product: abaloparatide-sMTS (Kindeva) |
| Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min | Experimental | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). Receives: Combination Product: abaloparatide-sMTS (Patheon); Combination Product: abaloparatide-sMTS (Kindeva) |
| Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min | Experimental | Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). Receives: Combination Product: abaloparatide-sMTS (Patheon); Combination Product: abaloparatide-sMTS (Kindeva) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: 4 single-dose administrations, separated by 48 hours.
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
Measured: 4 single-dose administrations, separated by 48 hours.
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
Measured: 4 single-dose administrations, separated by 48 hours.
Secondary outcomes (1)
Subjects with treatment-emergent AEs and SAEs
Measured: 14 ± 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start16 Nov 2020
- Primary completion9 Feb 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects were to receive a transdermal patch containing 300 μg abaloparatide for 4,5 and 7 minutes in 4 separate periods.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radius Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936984
- Sponsor's protocol ID
- BA058-05-023
- Status last verified
- Jun 2021
- First submitted
- 16 Jun 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 4-Period Crossover Study Evaluating the Bioequivalence of Two Abaloparatide-sMTS Treatments and the Effect of Small Variations in Wear-Time in Healthy Women.
- ClinicalTrials.gov ID
- NCT04936984
- Acronym / sponsor ID
- BA058-05-023
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, transdermal delivery, microneedle patch, solid microstructured transdermal system, abaloparatide TYMLOS®, abaloparatide-SC, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Radius Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 9 Feb 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS treatments 300 μg treatments applied to the thigh for 5 minutes.
Detailed description
This is a single site, open-label, randomized, 4-period crossover study to evaluate the bioequivalence of 2 abaloparatide-sMTS 300 μg treatments (Patheon sterile abaloparatide-sMTS and Kindeva ultra-low bioburden abaloparatide-sMTS) applied to the thigh for 5 minutes. The study will also evaluate the effect of small deviations in the wear-time of the Patheon abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS worn for the prescribed 5 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All subjects were to receive a transdermal patch containing 300 μg abaloparatide for 4,5 and 7 minutes in 4 separate periods.
| Arm | Type | Receives |
|---|---|---|
| Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min | Experimental | Combination Product: abaloparatide-sMTS (Patheon), Combination Product: abaloparatide-sMTS (Kindeva)Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
| Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min | Experimental | Combination Product: abaloparatide-sMTS (Patheon), Combination Product: abaloparatide-sMTS (Kindeva)Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
| Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min | Experimental | Combination Product: abaloparatide-sMTS (Patheon), Combination Product: abaloparatide-sMTS (Kindeva)Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
| Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min | Experimental | Combination Product: abaloparatide-sMTS (Patheon), Combination Product: abaloparatide-sMTS (Kindeva)Abaloparatide-sMTS is a drug-device combination product consisting of abaloparatide coated onto a microstructure array for transdermal administration of abaloparatide. The abaloparatide-sMTS is manufactured at Patheon (sterile environment) or Kindeva (low bioburden environment). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female subjects aged 40 to 65 years old, inclusive, at Screening
- Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 34 kg/m^2 inclusive)
- Laboratory tests within the normal range
- Serum 25-hydroxyvitamin D values must be > 20 ng/mL
Key exclusion criteria (4 listed)
- Presence or history of any disorder that may prevent the successful completion of the study.
- Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening;
- History of any cancer within the past 5 years other than squamous or basal cell carcinoma;
- History of allergy to abaloparatide or drugs in a similar pharmacological class;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abaloparatide-sMTS (Patheon)Also: abaloparatide-sMTSsingle-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes | Combination product | Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min, Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min, Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min, Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min |
| abaloparatide-sMTS (Kindeva)Also: abaloparatide-sMTSsingle-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes | Combination product | Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min, Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min, Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min, Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min |
| abaloparatide-sMTS (Patheon)Also: abaloparatide-sMTSsingle-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes | Combination product | Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min, Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min, Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min, Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min |
| abaloparatide-sMTS (Patheon)Also: abaloparatide-sMTSsingle-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes | Combination product | Kindeva sMTS 5 min, then Patheon sMTS 7 min, then Patheon sMTS 5 min, then Patheon sMTS 4 min, Patheon sMTS 4 min, then Patheon sMTS 5 min, then Patheon sMTS 7 min, then Kindeva sMTS 5 min, Patheon sMTS 5 min, then by Kindeva sMTS 5 min, then Patheon sMTS 4 min, then Patheon sMTS 7 min, Patheon sMTS 7 min, then Patheon sMTS 4 min, then Kindeva sMTS 5 min, then Patheon sMTS 5 min |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: 4 single-dose administrations, separated by 48 hours.
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
Time frame: 4 single-dose administrations, separated by 48 hours.
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
Time frame: 4 single-dose administrations, separated by 48 hours.
1 secondary outcome
Subjects with treatment-emergent AEs and SAEs
Time frame: 14 ± 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing abaloparatide-sMTS (Patheon) and abaloparatide-sMTS (Kindeva) in people with Osteoporosis, run by Radius Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) (time frame: 4 single-dose administrations, separated by 48 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.