OsteoporosisPhase 4NCT00446589
The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density
A Phase 4 study testing ibandronate and teriparatide in people with Osteoporosis, run by Papageorgiou General Hospital at 1 site in Greece.
Trial summary
Hemodialysis patients with low bone density (total hip T-score <-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy). Follow-up period: one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- ibandronate and teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2006to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bone mineral density (T-score<-2.5)
- Adynamic bone disease for the teriparatide group
- Increased osteoclast number on bone biopsy (high turnover) for the ibandronate group
- Calcium greater than 8.1 mg/dl
Who cannot join
- Suspected carcinoma
- Unstable clinical setting
Trial locations and contacts
1 site in 1 country.
About this study
Hemodialysis patients with low bone density (total hip T-score <-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy).
Follow-up period: one year. A second bone biopsy at the end of the study.
- Conditions
- Osteoporosis
- Being tested
- ibandronate, teriparatide
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibandronateDrug
iv 1mg ibandronate monthly for one year
teriparatideDrug
sc injection using a pen like device during every hemodialysis session (thrice a week)
| Study group | Role | What they receive |
|---|---|---|
| F | Experimental | HD pts suffering from osteoporosis and adynamic bone disease who received teriparatide Receives: Drug: teriparatide |
| I | Experimental | Hemodialysis pts suffering from osteoporosis who received iv ibandronate Receives: Drug: ibandronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.
Measured: one year
Secondary outcomes (1)
Effects of ibandronate and teriparatide on other bone disease markers
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startJul 2006
Why it stopped: due to financial problems
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papageorgiou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efstathios Mitsopoulos, Papageorgiou General Hospital
- Investigators
- Efstathios Mitsopoulos, MD, Principal investigator, Papageorgiou General Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446589
- Sponsor's protocol ID
- 47b/31-1-2005
- Status last verified
- Oct 2014
- First submitted
- 12 Mar 2007
- Last updated
- 29 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ibandronate or Teriparatide Therapy on Bone Histology and Biochemical Indices in Patients on Hemodialysis With Low Bone Mineral Density
- ClinicalTrials.gov ID
- NCT00446589
- Acronym / sponsor ID
- 47b/31-1-2005
- Conditions
- Osteoporosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to financial problems
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Papageorgiou General HospitalUniversity, hospital or other
- Study start
- Jul 2006
- First posted
- 13 Mar 2007 (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.
Hemodialysis patients with low bone density (total hip T-score <-2.5) will be assigned to receive teriparatide (those with histologic confirmation of adynamic bone disease) or ibandronate (subjects with increased osteoclast number on bone biopsy).
Follow-up period: one year. A second bone biopsy at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F | Experimental | Drug: teriparatideHD pts suffering from osteoporosis and adynamic bone disease who received teriparatide |
| I | Experimental | Drug: ibandronateHemodialysis pts suffering from osteoporosis who received iv ibandronate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bone mineral density (T-score<-2.5)
- Adynamic bone disease for the teriparatide group
- Increased osteoclast number on bone biopsy (high turnover) for the ibandronate group
- Calcium greater than 8.1 mg/dl
Key exclusion criteria (2 listed)
- Suspected carcinoma
- Unstable clinical setting
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 |
|---|---|---|
| ibandronateiv 1mg ibandronate monthly for one year | Drug | I |
| teriparatidesc injection using a pen like device during every hemodialysis session (thrice a week) | Drug | F |
Primary outcome
Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients.
Time frame: one year
1 secondary outcome
Effects of ibandronate and teriparatide on other bone disease markers
Time frame: one year
Results and safety
The study was stopped early (reason given: due to financial problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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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.
Efstathios Mitsopoulos, MD principal investigator
Papageorgiou General Hospital, Thessaloniki, Greece
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 ibandronate and teriparatide in people with Osteoporosis, run by Papageorgiou General Hospital at 1 site in Greece.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 29 Oct 2014. 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 Greece. 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?
The study was stopped early (reason given: due to financial problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of ibandronate and teriparatide on bone mineral density and bone histology in HD patients. (time frame: one 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 29 Oct 2014.