Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation.

NCT ID: NCT00423384

Last Updated: 2010-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-12-31

Brief 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 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.

Conditions

Renal Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Ibandronate

Group Type: EXPERIMENTAL

Ibandronate

Intervention Type: DRUG

I.v.

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Placebo

Placebo

Intervention Type: DRUG

Ibandronate

I.v.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Renal transplant recipients
• Adults, ≥ 18 years of age
• Either gender
• Signed informed consent

Exclusion Criteria

• 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.
• Use of any investigational drug (s) and/or device(s)
• Previous participation in this trial
• History of hypersensitivity to bisphosphonates

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Smerud Medical Research International AS

OTHER

Sponsor Role: lead

Responsible Party

Smerud Medical Research International AS

Principal Investigators

Knut T Smerud, MSc

Role: STUDY_DIRECTOR

Smerud Medical Research International AS, Drammensveien 41, N-0271 Oslo, Norway

Locations

Rikshospitalet-Radiumhospitalet Medical Center

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 39588131 (View on PubMed)

Other Identifiers

EUDRACT no.: 2006-003884-30

Identifier Type: -

Identifier Source: secondary_id

SMR-1471

Identifier Type: -

Identifier Source: org_study_id