OsteoporosisPhase 4NCT02156960
Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients
A Phase 4 study testing Denosumab treatment in osteoporotic patients, Teriparatide treatment in osteoporotic patients and Denosumab and teriparatide treatment in osteoporotic patients in people with Osteoporosis, run by Shinshu University at 1 site in Japan.
Trial summary
It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients. Read more about this study
- Who is it for?
- Ages 1 year to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Denosumab treatment in osteoporotic patients, Teriparatide treatment in osteoporotic patients and Denosumab and teriparatide treatment in osteoporotic patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- May 2014to Nov 2022
- Phase
- Phase 4
- 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 1 year to 120 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Osteoporotic patients
Who cannot join
- none
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
It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.
- Conditions
- Osteoporosis
- Being tested
- Denosumab treatment in osteoporotic patients, Teriparatide treatment in osteoporotic patients, Denosumab and teriparatide treatment in osteoporotic patients
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denosumab treatment in osteoporotic patientsDrug
To examine the effectiveness of denosumab in osteoporotic patients
Teriparatide treatment in osteoporotic patientsDrug
To examine the effectiveness of teriparatide in osteoporotic patients
Denosumab and teriparatide treatment in osteoporotic patientsDrug
To examine the effectiveness of denosumab and teriparatide in osteoporotic patients
| Study group | Role | What they receive |
|---|---|---|
| Denosumab and/or teriparatide treatment | Experimental | Denosumab and/or teriparatide treatment in osteoporotic patients Receives: Drug: Denosumab treatment in osteoporotic patients; Drug: Teriparatide treatment in osteoporotic patients; Drug: Denosumab and teriparatide treatment in osteoporotic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of bone mineral density
Bone mineral density will be examined every 4-6 months to evaluate the suitability of the drug.
Measured: every 4-6 months
Secondary outcomes (1)
Changes of bone turnover markers
Bone turnover markers will be examined every 3-6 months to evaluate the suitability of the drug.
Measured: every 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT02156960
- Sponsor's protocol ID
- Deno-PTH2365
- Status last verified
- Oct 2020
- First submitted
- 31 May 2014
- Last updated
- 22 Oct 2020
- Results posted
- No
Publications
Nakamura Y, Kamimura M, Ikegami S, Mukaiyama K, Uchiyama S, Taguchi A, Kato H. Changes in serum vitamin D and PTH values using denosumab with or without bisphosphonate pre-treatment in osteoporotic patients: a short-term study. BMC Endocr Disord. 2015 Dec 15;15:81. doi: 10.1186/s12902-015-0077-3.
PubMed 26666998
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Bone Metabolic Markers and Bone Mineral Density After Denosumab and/or Teriparatide Treatment in Japanese Osteoporotic Patients
- ClinicalTrials.gov ID
- NCT02156960
- Acronym / sponsor ID
- Deno-PTH2365
- Conditions
- Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2022 (estimated)
- First posted
- 5 Jun 2014 (estimated)
- 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.
It has not been well known about the changes of bone metabolic markers, bone mineral density and other bone-related markers after teriparatide and/or denosumab treatment in Japanese osteoporotic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denosumab and/or teriparatide treatment | Experimental | Drug: Denosumab treatment in osteoporotic patients, Drug: Teriparatide treatment in osteoporotic patients, Drug: Denosumab and teriparatide treatment in osteoporotic patientsDenosumab and/or teriparatide treatment in osteoporotic patients |
Who may qualify
- Ages
- 1 year to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoporotic patients
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Denosumab treatment in osteoporotic patientsTo examine the effectiveness of denosumab in osteoporotic patients | Drug | Denosumab and/or teriparatide treatment |
| Teriparatide treatment in osteoporotic patientsTo examine the effectiveness of teriparatide in osteoporotic patients | Drug | Denosumab and/or teriparatide treatment |
| Denosumab and teriparatide treatment in osteoporotic patientsTo examine the effectiveness of denosumab and teriparatide in osteoporotic patients | Drug | Denosumab and/or teriparatide treatment |
Primary outcome
Changes of bone mineral density
Time frame: every 4-6 months
Bone mineral density will be examined every 4-6 months to evaluate the suitability of the drug.
1 secondary outcome
Changes of bone turnover markers
Time frame: every 3-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 26666998Nakamura Y, Kamimura M, Ikegami S, Mukaiyama K, Uchiyama S, Taguchi A, Kato H. Changes in serum vitamin D and PTH values using denosumab with or without bisphosphonate pre-treatment in osteoporotic patients: a short-term study. BMC Endocr Disord. 2015 Dec 15;15:81. doi: 10.1186/s12902-015-0077-3.
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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 4 study testing Denosumab treatment in osteoporotic patients, Teriparatide treatment in osteoporotic patients and Denosumab and teriparatide treatment in osteoporotic patients 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 22 Oct 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Yukio Nakamura, MD, PhD (+81-263-37-2659, yxn14@aol.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of bone mineral density (time frame: every 4-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156960, which also lists 1 linked publication.
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 22 Oct 2020.