Bone LossPhase 4SMARTNCT00738257
A Prospective, Multicentre, Open-label Randomised Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients.
A Phase 4 study testing Pamidronate in people with Bone Loss, run by Novartis Pharmaceuticals at 1 site in United Kingdom.
Trial summary
The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bone Loss
- What is being tested?
- Pamidronate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2000to Dec 2004
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First or second kidney transplant recipients, aged 18-75 years, PTH > 150 pg/ml
- De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.
Who cannot join
- Previous or current bone disease unrelated to end stage renal failure.
- Patients with PTH < 150pg/ml who may be at risk of adynamic bone disease.
- Treatment at any time with a bisphosphonate.
- d. Calcitonin treatment during the previous month.
- Malignancy (current or history within last 5 years)
- Pregnancy or lactation, or women of childbearing potential unwilling to use an effective form of contraception for the 12 month duration of the study.
- Protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2 Year Prospective, Multicentre, Open-label, Randomised, Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients (With a PTH > 150pg/ml) on a Ciclosporin A and Glucocorticoid Based Immunosuppressive Regimen.
The purpose of the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen.
- Conditions
- Bone Loss
- Being tested
- Pamidronate
- Keywords
- Renal, transplant,, pamidronate,, ciclosporin,, Ciclosporin A,, steroids,, bone mineral density,, fracture rates, immunosuppressive, regimen
- 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.
PamidronateDrug
| Study group | Role | What they receive |
|---|---|---|
| Parmidronate | Experimental | Not described Receives: Drug: Pamidronate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJun 2000
- Primary completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Cunningham, MD, Principal investigator, Royal London Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738257
- Sponsor's protocol ID
- NEO-GB-50
- Other IDs
- ARE-GB-01
- Acronym
- SMART
- Status last verified
- May 2010
- First submitted
- 18 Aug 2008
- Last updated
- 17 May 2010
- Results posted
- No
Publications
Walsh SB, Altmann P, Pattison J, Wilkie M, Yaqoob MM, Dudley C, Cockwell P, Sweny P, Banks LM, Hall-Craggs M, Noonan K, Andrews C, Cunningham J. Effect of pamidronate on bone loss after kidney transplantation: a randomized trial. Am J Kidney Dis. 2009 May;53(5):856-65. doi: 10.1053/j.ajkd.2008.11.036.
PubMed 19393473
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 Year Prospective, Multicentre, Open-label, Randomised, Controlled Study to Investigate the Effectiveness of Pamidronate in the Prevention of Bone Loss in de Novo Renal Transplant Patients (With a PTH > 150pg/ml) on a Ciclosporin A and Glucocorticoid Based Immunosuppressive Regimen.
- ClinicalTrials.gov ID
- NCT00738257
- Acronym / sponsor ID
- SMART / NEO-GB-50
- Conditions
- Bone Loss
- Keywords
- Renal, transplant,, pamidronate,, ciclosporin,, Ciclosporin A,, steroids,, bone mineral density,, fracture rates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Primary completion
- Dec 2004 (actual)
- First posted
- 20 Aug 2008 (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 the study was to evaluate the effect of Pamidronate on bone mineral density loss and fracture rates up to 2 years, in post renal-transplant subjects on a Ciclosporin A and glucocorticoid based immunosuppressive regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parmidronate | Experimental | Drug: Pamidronate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First or second kidney transplant recipients, aged 18-75 years, PTH > 150 pg/ml
- De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.
Key exclusion criteria (7 listed)
- Previous or current bone disease unrelated to end stage renal failure.
- Patients with PTH < 150pg/ml who may be at risk of adynamic bone disease.
- Treatment at any time with a bisphosphonate.
- d. Calcitonin treatment during the previous month.
- Malignancy (current or history within last 5 years)
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 |
|---|---|---|
| Pamidronate | Drug | Parmidronate |
Primary outcome
Not reported in the source record.
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 17 May 2010.
- Derived from this study: PubMed 19393473Walsh SB, Altmann P, Pattison J, Wilkie M, Yaqoob MM, Dudley C, Cockwell P, Sweny P, Banks LM, Hall-Craggs M, Noonan K, Andrews C, Cunningham J. Effect of pamidronate on bone loss after kidney transplantation: a randomized trial. Am J Kidney Dis. 2009 May;53(5):856-65. doi: 10.1053/j.ajkd.2008.11.036.
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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.
John Cunningham, MD principal investigator
Royal London Hospital
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 Pamidronate in people with Bone Loss, run by Novartis Pharmaceuticals at 1 site in United Kingdom.
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 2 inclusion and 7 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 17 May 2010. 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 United Kingdom. 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738257, which also lists 1 linked publication.
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 17 May 2010.