OsteopeniaPhase 4NCT00164008
Comparison of Pamidronate With Zoledronic Acid for Transplant Related Bone Loss Prevention
A Phase 4 study testing zoledronic acid vs pamidronate in people with Osteopenia and Complications of Heart-lung Transplant, run by Bayside Health.
Trial summary
The purpose of this trial is to see whether zoledronic acid is better than pamidronate to treat low bone density in heart and lung transplant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteopenia, Complications of Heart-lung Transplant, Other Complications of Lung Transplant
- What is being tested?
- zoledronic acid vs pamidronate
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Dec 2005
- 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
- reduced bone density as indicated by a bone density T score <-1.in either the lumbar spine or femoral neck
- have undergone or are on the waiting list for heart or lung transplantation
- are receiving adequate calcium and vitamin D therapy
- have provided written informed consent prior to participation in the trial
Who cannot join
- untreated hypogonadism, hypothyroidism or hyperthyroidism
- acute or major organ rejection or intercurrent illness
- pregnancy or breastfeeding
About this study
Official title: Comparison Between Pamidronate and Zoledronic Acid for the Treatment of Heart and Lung Transplant Related Osteopaenia and Osteoporosis
The purpose of this trial is to see whether zoledronic acid is better than pamidronate to treat low bone density in heart and lung transplant patients.
- Conditions
- Osteopenia, Complications of Heart-lung Transplant, Other Complications of Lung Transplant
- Being tested
- zoledronic acid vs pamidronate
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acid vs pamidronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density of lumbar spine at 12 months as measured by DEXA.
Secondary outcomes (1)
Bone mineral density of femoral neck at 12 months as measured by DEXA.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Duncan J Topliss, MD, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164008
- Sponsor's protocol ID
- 101/02
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 5 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Pamidronate and Zoledronic Acid for the Treatment of Heart and Lung Transplant Related Osteopaenia and Osteoporosis
- ClinicalTrials.gov ID
- NCT00164008
- Acronym / sponsor ID
- 101/02
- Conditions
- Osteopenia, Complications of Heart-lung Transplant, Other Complications of Lung Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Novartis
- Study start
- Oct 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 14 Sep 2005 (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 purpose of this trial is to see whether zoledronic acid is better than pamidronate to treat low bone density in heart and lung transplant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- reduced bone density as indicated by a bone density T score <-1.in either the lumbar spine or femoral neck
- have undergone or are on the waiting list for heart or lung transplantation
- are receiving adequate calcium and vitamin D therapy
- have provided written informed consent prior to participation in the trial
Key exclusion criteria (3 listed)
- untreated hypogonadism, hypothyroidism or hyperthyroidism
- acute or major organ rejection or intercurrent illness
- pregnancy or breastfeeding
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 |
|---|---|---|
| zoledronic acid vs pamidronate | Drug | – |
Primary outcome
Bone mineral density of lumbar spine at 12 months as measured by DEXA.
1 secondary outcome
Bone mineral density of femoral neck at 12 months as measured by DEXA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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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.
Duncan J Topliss, MD principal investigator
The Alfred
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing zoledronic acid vs pamidronate in people with Osteopenia and Complications of Heart-lung Transplant, run by Bayside Health.
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 3 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: finished, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone mineral density of lumbar spine at 12 months as measured by DEXA.. 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 5 Dec 2013.