OsteoporosisNCT02166437
Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese
An observational study of Osteoporosis, run by Tomidahama Hospital at 1 site in Japan.
Trial summary
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoporosis
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2013to Nov 2018
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tion Osteoporotic patients who admit to our hospital
Who may be able to join
- severe osteoporotic patients
Who cannot join
- cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, teriparatide)
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Tomidahama Hospital
Yokkaichi, Mie-ken, 510-8008
Rui Niimi, MD, PhD, (81)-59-365-0023, furikakefuri@hotmail.co.jp
Rui Niimi, MD, PhD
About this study
Official title: Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese, Prospective Study
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.
Read the detailed description
Registry criteria: Patients treated in the investigators hospital using teriparatide. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (< young adult mean 65%).
Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, BMD, teriparatide, bisphosphonate, denosmab
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alendronate | Patients treated with alendronate | |
| Minodronate | Patients treated with minodronate | |
| Denosmab | Patients treated with denosmab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment
The investigators plan to analyze 500 patients who treated with bisphosphonate or denosmab following daily teriparatide treatment.
We investigate changes in BMD and bone turnover markers.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2017 (estimated)
- Study completionNov 2018 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomidahama Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toshihiko Kono, Tomidahama Hospital
- Investigators
- Rui Niimi, MD, PhD, Study director, Tomidahama Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166437
- Sponsor's protocol ID
- IRB TH No 6-3
- Status last verified
- Oct 2016
- First submitted
- 15 Jun 2014
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results of Bisphosphonate and Denosumab Therapy Following Teriparatide Therapy for Japanese, Prospective Study
- ClinicalTrials.gov ID
- NCT02166437
- Acronym / sponsor ID
- IRB TH No 6-3
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, BMD, teriparatide, bisphosphonate, denosmab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tomidahama HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 18 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.
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of bisphosphonate and denosumab randomly divided following daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.
Detailed description
Registry criteria: Patients treated in the investigators hospital using teriparatide. Enrolled patients are severe osteoporosis; more than two previous osteoporotic fractures, low BMD (< young adult mean 65%).
Interventions: blood analyses and dual-energy X-ray absorptiometry (DXA) every 4 months Informed consent: Written informed consent will be obtained. Sample size: Five-hundreds participants
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alendronate | – | –Patients treated with alendronate |
| Minodronate | – | –Patients treated with minodronate |
| Denosmab | – | –Patients treated with denosmab |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tion Osteoporotic patients who admit to our hospital
Key inclusion criteria (1 listed)
- severe osteoporotic patients
Key exclusion criteria (1 listed)
- cancer, hypercalcemia, etc (i.e. patients who could not use bisphosphonate, denosmab, teriparatide)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment
Time frame: Up to 36 months
The investigators plan to analyze 500 patients who treated with bisphosphonate or denosmab following daily teriparatide treatment. We investigate changes in BMD and bone turnover markers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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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.
Rui Niimi, MD, PhD study director
Tomidahama Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Tomidahama Hospital 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 19 Oct 2016. 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.
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 Rui Niimi, MD, PhD ((81)-59-365-0023, furikakefuri@hotmail.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical results of bisphosphonate vs. denosmab following daily teriparatide treatment (time frame: Up to 36 months). 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 19 Oct 2016.