OsteoporosisPhase 2NCT03702140
Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
A Phase 2 study testing "Teriparatide", "Forteo® or Teribon" in people with Osteoporosis, run by Shinshu University at 1 site in Japan.
Trial summary
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients: 1. The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months. 2. Read more about this study
- Who is it for?
- Ages 20 to 120 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- "Teriparatide", "Forteo® or Teribon"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteJapan
- Study dates
- 9 Oct 2018to 8 Oct 2025
- Phase
- Phase 2
- 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 20 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoporotic patients who want to take teriparatide and denosumab
Who cannot join
- Patients who are allergic to teriparatide or denosumab Patients who are pregnant or breast-feedin
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Yukio Nakamura
Matsumoto, Nagano, 3908621
Yukio Nakamura, MD, PhD, +81-263-37-2659, yxn14@aol.jp
Yukio Nakamura, MD, PhD
About this study
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients:
- The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months.
- The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months.
- The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.
- Conditions
- Osteoporosis
- Being tested
- "Teriparatide", "Forteo® or Teribon"
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Teriparatide", "Forteo® or Teribon"Drug
To examine the effects of terimaratide less than 6 months in osteoporosis
| Study group | Role | What they receive |
|---|---|---|
| TPTD 6M | Active comparator | Not described Receives: Drug: "Teriparatide", "Forteo® or Teribon" |
| TPTD 6-12M | Active comparator | Not described Receives: Drug: "Teriparatide", "Forteo® or Teribon" |
| TPTD 12-24M | Active comparator | Not described Receives: Drug: "Teriparatide", "Forteo® or Teribon" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: Change from Baseline Values at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start9 Oct 2018
- Primary completion8 Oct 2023 (estimated)
- Study completion8 Oct 2025 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shinshu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukio Nakamura, Shinshu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702140
- Sponsor's protocol ID
- PTH-DMAb 2018
- Status last verified
- Sep 2021
- First submitted
- 8 Oct 2018
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination How the Administration Period of Teriparatide Affects Bone Metabolism and Bone Mineral Density Prior to Denosumab Therapy
- ClinicalTrials.gov ID
- NCT03702140
- Acronym / sponsor ID
- PTH-DMAb 2018
- Conditions
- Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 8 Oct 2023 (estimated)
- Study completion
- 8 Oct 2025 (estimated)
- First posted
- 10 Oct 2018 (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.
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in osteoporosis patients:
- The administration period of teriparatide is less than 6 months and thereafter, denosumab for 24 months.
- The administration period of teriparatide is from 6 to 12 months and thereafter, denosumab for 24 months.
- The administration period of teriparatide is more than 12 months and thereafter, denosumab for 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TPTD 6M | Active comparator | Drug: "Teriparatide", "Forteo® or Teribon" |
| TPTD 6-12M | Active comparator | Drug: "Teriparatide", "Forteo® or Teribon" |
| TPTD 12-24M | Active comparator | Drug: "Teriparatide", "Forteo® or Teribon" |
Who may qualify
- Ages
- 20 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoporotic patients who want to take teriparatide and denosumab
Key exclusion criteria (1 listed)
- Patients who are allergic to teriparatide or denosumab Patients who are pregnant or breast-feedin
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 |
|---|---|---|
| "Teriparatide", "Forteo® or Teribon"To examine the effects of terimaratide less than 6 months in osteoporosis | Drug | TPTD 12-24M, TPTD 6-12M, TPTD 6M |
Primary outcome
Bone mineral density
Time frame: Change from Baseline Values at 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "Teriparatide", "Forteo® or Teribon" in people with Osteoporosis, run by Shinshu University at 1 site in Japan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Sep 2021. 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 Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Change from Baseline Values at 1 year). 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 21 Sep 2021.