Renal TransplantPhase 2/3NCT00423384
Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation.
A Phase 2/3 study testing Ibandronate in people with Renal Transplant, run by Smerud Medical Research International AS at 1 site in Norway.
Trial summary
Loss of bone mass is a common complication in patients with end-stage-renal failure, both before and particularly after transplantation. In addition to standard underlying therapy with calcium and active vitamin D, we will study the effect of ibandronate (a bisphosphonate) versus placebo on bone mineral density as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Ibandronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Dec 2010
- Phase
- Phase 2/3
- 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
- Renal transplant recipients
- Adults, ≥ 18 years of age
- Either gender
- Signed informed consent
Who cannot join
- Persisting s-Ca > 2.55 mmol/L (through the first two weeks after transplantation)
- Impaired graft functioning (estimated GFR <30 ml/min)
- Previous (within the last 12 months) treatment with bisphosphonates, sodium fluoride, calcitonin, strontium, PTH, SERM, growth hormone or anabolic steroids at any time before transplantation.
- Known adynamic bone disease
- Previous parathyroidectomy
- Pregnant or lactating females or females of childbearing potential who do not use an approved method of contraception (oral contraceptives or IUD); positive urine pregnancy test, where applicable.
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- Use of any investigational drug (s) and/or device(s)
- Previous participation in this trial
- History of hypersensitivity to bisphosphonates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ibandronate Versus Placebo as add-on to Active Vitamin D and Calcium in the Prevention of Bone Loss After Renal Transplantation.
Loss of bone mass is a common complication in patients with end-stage-renal failure, both before and particularly after transplantation. In addition to standard underlying therapy with calcium and active vitamin D, we will study the effect of ibandronate (a bisphosphonate) versus placebo on bone mineral density as well as incidence of fracture rates after kidney transplantation.We also wish to study whether any prevented bone loss will also lead to reduced cardiovascular disease. Patients will be followed for 12 months after transplantation, and the ibandronate treatment is one injection every 3 months.
Read the detailed description
Demographic, medical history, previous and current medication, as well as baseline measurements of Bone Mineral Density (BMD), laboratory efficacy and safety variables as well as Quality-of-Life scores will be undertaken in the period from 1 week prior to transplantation until 1 week after transplantation. In this period, any existing fractures will be determined using traditional x-ray of the thoraco-lumbar columna. Renal graft functioning as well as transplantation complications will be followed tightly, and calcium supplementation as well as active vitamin D (calcitriol) will be administered together with the standard immunosuppressive regimen.
As soon as patients have recovered from transplantation, and renal functioning is considered sufficiently stable, and no later than 28 days after the transplantation, qualified patients will be randomised to receive either ibandronate or placebo, stratified by gender. Bone mineral density and most of the clinical data and laboratory tests will then be followed until 12 months after transplantation as described in the attached flowchart (section 11.1), with hospital visits for administration of study drugs and follow-up of at 13, 26, 39 and 52 weeks after transplantation. Furthermore, all the patients will be followed prospectively from the time of transplantation and for ten years with regard to cardiovascular events. Data concerning cardiovascular events will be collected from the Norwegian renal registry for the whole study population in the follow up period of about 10 years.
- Conditions
- Renal Transplant
- Being tested
- Placebo, Ibandronate
- Keywords
- Ibandronate, Placebo, Doubleblind, Bone, loss, Kidney, transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
IbandronateDrug
I.v.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ibandronate Receives: Drug: Ibandronate |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups.
Measured: December 2010
Secondary outcomes (10)
Lumbar BMD change; absolute and relative
Measured: December 2010
Hip BMD change; absolute and relative
Measured: December 2010
Radial BMD change; absolute and relative
Measured: December 2010
Femural BMD change; absolute and relative
Measured: December 2010
Change in height
Measured: December 2010
Change in biochemical efficacy and bone markers
Measured: December 2010
Change in HRQoL scores (SF-36 and mini OQOL)
Measured: December 2010
Incidence of post-transplant complications
Measured: December 2010
Frequency of clinically significant safety laboratory variables
Measured: December 2010
Adverse event rates
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
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 Renal TransplantStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smerud Medical Research International AS
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Investigators
- Knut T Smerud, MSc, Study director, Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423384
- Sponsor's protocol ID
- SMR-1471
- Other IDs
- EUDRACT no.: 2006-003884-30
- Status last verified
- Mar 2010
- First submitted
- 17 Jan 2007
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Strommen RC, Godang K, Hovd MH, Finnes TE, Smerud K, Hartmann A, Asberg A, Bollerslev J, Pihlstrom HK. Hip geometry and strength remain stable the first year after kidney transplantation-an ibandronate/placebo post hoc analysis. JBMR Plus. 2024 Oct 24;8(12):ziae130. doi: 10.1093/jbmrpl/ziae130. eCollection 2024 Dec.
PubMed 39588131
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibandronate Versus Placebo as add-on to Active Vitamin D and Calcium in the Prevention of Bone Loss After Renal Transplantation.
- ClinicalTrials.gov ID
- NCT00423384
- Acronym / sponsor ID
- SMR-1471
- Conditions
- Renal Transplant
- Keywords
- Ibandronate, Placebo, Doubleblind, Bone, loss, Kidney, transplant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Smerud Medical Research International ASUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Jan 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 18 Jan 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.
Loss of bone mass is a common complication in patients with end-stage-renal failure, both before and particularly after transplantation. In addition to standard underlying therapy with calcium and active vitamin D, we will study the effect of ibandronate (a bisphosphonate) versus placebo on bone mineral density as well as incidence of fracture rates after kidney transplantation.We also wish to study whether any prevented bone loss will also lead to reduced cardiovascular disease. Patients will be followed for 12 months after transplantation, and the ibandronate treatment is one injection every 3 months.
Detailed description
Demographic, medical history, previous and current medication, as well as baseline measurements of Bone Mineral Density (BMD), laboratory efficacy and safety variables as well as Quality-of-Life scores will be undertaken in the period from 1 week prior to transplantation until 1 week after transplantation. In this period, any existing fractures will be determined using traditional x-ray of the thoraco-lumbar columna. Renal graft functioning as well as transplantation complications will be followed tightly, and calcium supplementation as well as active vitamin D (calcitriol) will be administered together with the standard immunosuppressive regimen.
As soon as patients have recovered from transplantation, and renal functioning is considered sufficiently stable, and no later than 28 days after the transplantation, qualified patients will be randomised to receive either ibandronate or placebo, stratified by gender. Bone mineral density and most of the clinical data and laboratory tests will then be followed until 12 months after transplantation as described in the attached flowchart (section 11.1), with hospital visits for administration of study drugs and follow-up of at 13, 26, 39 and 52 weeks after transplantation. Furthermore, all the patients will be followed prospectively from the time of transplantation and for ten years with regard to cardiovascular events. Data concerning cardiovascular events will be collected from the Norwegian renal registry for the whole study population in the follow up period of about 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: IbandronateIbandronate |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Renal transplant recipients
- Adults, ≥ 18 years of age
- Either gender
- Signed informed consent
Key exclusion criteria (9 listed)
- Persisting s-Ca > 2.55 mmol/L (through the first two weeks after transplantation)
- Impaired graft functioning (estimated GFR <30 ml/min)
- Previous (within the last 12 months) treatment with bisphosphonates, sodium fluoride, calcitonin, strontium, PTH, SERM, growth hormone or anabolic steroids at any time before transplantation.
- Known adynamic bone disease
- Previous parathyroidectomy
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 |
|---|---|---|
| PlaceboPlacebo | Drug | 2 |
| IbandronateI.v. | Drug | 1 |
Primary outcome
Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups.
Time frame: December 2010
10 secondary outcomes
Lumbar BMD change; absolute and relative
Time frame: December 2010
Hip BMD change; absolute and relative
Time frame: December 2010
Radial BMD change; absolute and relative
Time frame: December 2010
Femural BMD change; absolute and relative
Time frame: December 2010
Change in height
Time frame: December 2010
Change in biochemical efficacy and bone markers
Time frame: December 2010
Change in HRQoL scores (SF-36 and mini OQOL)
Time frame: December 2010
Incidence of post-transplant complications
Time frame: December 2010
Frequency of clinically significant safety laboratory variables
Time frame: December 2010
Adverse event rates
Time frame: December 2010
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
- Derived from this study: PubMed 39588131Strommen RC, Godang K, Hovd MH, Finnes TE, Smerud K, Hartmann A, Asberg A, Bollerslev J, Pihlstrom HK. Hip geometry and strength remain stable the first year after kidney transplantation-an ibandronate/placebo post hoc analysis. JBMR Plus. 2024 Oct 24;8(12):ziae130. doi: 10.1093/jbmrpl/ziae130. eCollection 2024 Dec.
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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.
Knut T Smerud, MSc study director
Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ibandronate in people with Renal Transplant, run by Smerud Medical Research International AS at 1 site in Norway.
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 9 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 24 Mar 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 Norway. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups. (time frame: December 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00423384, 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 24 Mar 2010.