OsteoporosisNCT02304887
The Relationship Between the Residual Renal Function and Osteoporosis Treatment
An observational study of Osteoporosis, run by Toshihiko Kono at 1 site in Japan.
Trial summary
The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Bis, SERM Teriparatide, Denosumab
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2006to Jan 2019
- 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: Osteoporosis treatment patients
Who may be able to join
- Osteoporosis patients
Who cannot join
- eGFR < 15
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
The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.
Read the detailed description
Chronic kidney disease (CKD)- mineral and bone disorder (CKD-MBD) is one of the topic in osteoporosis treatment. As many osteoporotic patients are older, many patients are under the deterioration of the renal function. In addition, several drugs might have the potential for kidney damage. But the relationship between osteoporosis drugs and kidney damage is unclear.
The main objective of this study is to reveal relationship between osteoporosis drugs and kidney damage.
- Conditions
- Osteoporosis
- Being tested
- Bis, SERM Teriparatide, Denosumab
- Keywords
- Osteoporosis, Bone mineral densisty, Renal function, CKD-MBD
- Medical subject headings
- Osteoporosis, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bis, SERM Teriparatide, DenosumabDrug
Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.
| Study group | Role | What they receive |
|---|---|---|
| Bisphosphonate | Not described Receives: Drug: Bis, SERM Teriparatide, Denosumab | |
| Selective estrogen receptor modulator | Not described Receives: Drug: Bis, SERM Teriparatide, Denosumab | |
| Teriparatide | Not described Receives: Drug: Bis, SERM Teriparatide, Denosumab | |
| Senosumab | Not described Receives: Drug: Bis, SERM Teriparatide, Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal renal function changes by osteoporotic treatment
Measured: Up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJan 2006
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toshihiko Kono
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Toshihiko Kono, Tomidahama Hospital
- Investigators
- Rui Niimi, MD, Principal investigator, Tomidahama Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304887
- Sponsor's protocol ID
- IRB TH No 9-1
- Status last verified
- Nov 2016
- First submitted
- 27 Nov 2014
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Residual Renal Function and Osteoporosis Treatment
- ClinicalTrials.gov ID
- NCT02304887
- Acronym / sponsor ID
- IRB TH No 9-1
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Bone mineral densisty, Renal function, CKD-MBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Toshihiko KonoUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 2 Dec 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.
The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.
Detailed description
Chronic kidney disease (CKD)- mineral and bone disorder (CKD-MBD) is one of the topic in osteoporosis treatment. As many osteoporotic patients are older, many patients are under the deterioration of the renal function. In addition, several drugs might have the potential for kidney damage. But the relationship between osteoporosis drugs and kidney damage is unclear.
The main objective of this study is to reveal relationship between osteoporosis drugs and kidney damage.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bisphosphonate | – | Drug: Bis, SERM Teriparatide, Denosumab |
| Selective estrogen receptor modulator | – | Drug: Bis, SERM Teriparatide, Denosumab |
| Teriparatide | – | Drug: Bis, SERM Teriparatide, Denosumab |
| Senosumab | – | Drug: Bis, SERM Teriparatide, Denosumab |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Osteoporosis treatment patients
Key inclusion criteria (1 listed)
- Osteoporosis patients
Key exclusion criteria (1 listed)
- eGFR < 15
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 |
|---|---|---|
| Bis, SERM Teriparatide, DenosumabOsteoporotic drugs are assigned according to the disease severity, gender, age and so on. | Drug | Bisphosphonate, Selective estrogen receptor modulator, Senosumab, Teriparatide |
Primary outcome
Longitudinal renal function changes by osteoporotic treatment
Time frame: Up to 120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 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 principal investigator
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 Toshihiko Kono 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 25 Nov 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 ((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?
Longitudinal renal function changes by osteoporotic treatment (time frame: Up to 120 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 25 Nov 2016.