OsteoporosisNCT01956461
Effects of 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 daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition. 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
- Sep 2010to Oct 2017
- How long will I take part?
- 4 Years
- 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: 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 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
About this study
In this study, the investigators would like to analyze the bone mineral density (BMD) , bone turnover makers, and fracture prevention effects of daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.
Several determinants were reported to be related to subsequent BMD increase, such as baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive discussion is lacking. Specifically, there analyses were performed fragmentarily.
Read more
The main objective of this study is to reveal the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.
Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As a result, there is a lot of nursing home. But there are few reports concerning to the efficacy of teriparatide treatment in nursing home patients. The second objective is to reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes, bone turnover makers change, and adverse events.
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, nursing home
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The determinants related to BMD increase and fracture prevention for teriparatide treatment
The investigators plan to analyze 500 patients who undergo teriparatide treatments 12 months. To enroll 500 participants, up to 24 months is required beside 12 months treatment periods.
We investigate several determinants related to BMD increase, such as baseline age, gender, body mass index, BMD, BTMs, history of fracture, and prior treatment. We also investigate determinants related to fracture prevention effects by teriparatide treatment, such as baseline age, gender, body mass index, BMD, BTMs, history of fracture, prior treatment, walking ability, dementia,and site of living.
To determine the response variables of BMD changes and fracture prevention effects, initially univariate analyses are performed by Spearman correlation coefficients and Mann-Whitney U test. Data are further analyzed with a multiple regression. To estimate odds ratios and 95% confidence intervals (95% CIs) of each determinants, logistic regression analyses are performed.
Measured: Up to 36 months
Secondary outcomes (1)
BMD and BTMs response, and fracture prevention effects of teriparatide for the patients in nursing home
We plan to evaluate longitudinal BMD and BTMs changes for 24 months. BMD was evaluated every four months, ans BTMs are evaluated one months after treatment, and every four months. Fracture prevention effects are evaluated by radiography, if fracture is suspected. Statical analyses are performed using Spearman correlation coefficients, paired t-test, Mann-Whitney U test, and Kaplan-Meier method.
Measured: Oct 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2010
- Primary completionNov 2016 (estimated)
- Study completionOct 2017 (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)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Tomidahama Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toshihiko Kono, Tomidahama Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956461
- Sponsor's protocol ID
- IRB TH No 6
- Status last verified
- Oct 2016
- First submitted
- 21 Sep 2013
- 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
- Effects of Teriparatide Therapy for Japanese
- ClinicalTrials.gov ID
- NCT01956461
- Acronym / sponsor ID
- IRB TH No 6
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, BMD, teriparatide, nursing home
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tomidahama HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 8 Oct 2013 (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 daily teriparatide in Japanese patients under clinical practice. The participants are treated in the investigators hospital, who are under severe osteoporotic condition.
Several determinants were reported to be related to subsequent BMD increase, such as baseline bone turnover markers (BTMs), low BMD at baseline, age, prior treatment, but comprehensive discussion is lacking. Specifically, there analyses were performed fragmentarily.
The main objective of this study is to reveal the determinants of subsequent BMD increase and fracture preventing effect by teriparatide.
Next, in Japan, as the baby boom generation retires, aging and depopulation occur rapidly. As a result, there is a lot of nursing home. But there are few reports concerning to the efficacy of teriparatide treatment in nursing home patients. The second objective is to reveal the efficacy of teriparatide for patients living nursing home, especially BMD changes, bone turnover makers change, and adverse events.
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
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 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
The determinants related to BMD increase and fracture prevention for teriparatide treatment
Time frame: Up to 36 months
The investigators plan to analyze 500 patients who undergo teriparatide treatments 12 months. To enroll 500 participants, up to 24 months is required beside 12 months treatment periods. We investigate several determinants related to BMD increase, such as baseline age, gender, body mass index, BMD, BTMs, history of fracture, and prior treatment. We also investigate determinants related to fracture prevention effects by teriparatide treatment, such as baseline age, gender, body mass index, BMD, BTMs, history of fracture, prior treatment, walking ability, dementia,and site of living. To determine the response variables of BMD changes and fracture prevention effects, initially univariate analyses are performed by Spearman correlation coefficients and Mann-Whitney U test. Data are further analyzed with a multiple regression. To estimate odds ratios and 95% confidence intervals (95% CIs) of each determinants, logistic regression analyses are performed.
1 secondary outcome
BMD and BTMs response, and fracture prevention effects of teriparatide for the patients in nursing home
Time frame: Oct 2014
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.
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?
The determinants related to BMD increase and fracture prevention for 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.