Ibandronate Versus Placebo in the Prevention of Bone Loss After Renal Transplantation. - Full Text View

Sponsor:	Smerud Medical Research International AS
Collaborator:	Rikshospitalet HF
Information provided by:	Smerud Medical Research International AS
ClinicalTrials.gov Identifier:	NCT00423384

Purpose

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.

Condition	Intervention	Phase
Renal Transplant	Drug: Placebo Drug: Ibandronate	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Ibandronate Versus Placebo as add-on to Active Vitamin D and Calcium in the Prevention of Bone Loss After Renal Transplantation.

Resource links provided by NLM:

MedlinePlus related topics: Calcium Kidney Transplantation

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by Smerud Medical Research International AS:

Primary Outcome Measures:

Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups. [ Time Frame: December 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lumbar BMD change; absolute and relative [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
Hip BMD change; absolute and relative [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
Radial BMD change; absolute and relative [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
Femural BMD change; absolute and relative [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
Change in height [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
Change in biochemical efficacy and bone markers [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
Change in HRQoL scores (SF-36 and mini OQOL) [ Time Frame: December 2010 ] [ Designated as safety issue: No ]
Incidence of post-transplant complications [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
Frequency of clinically significant safety laboratory variables [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]
Adverse event rates [ Time Frame: December 2010 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	130
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ibandronate	Drug: Ibandronate I.v.
2: Placebo Comparator	Drug: Placebo Placebo

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423384

Contacts

Contact: Anders Hartmann, MD, PhD	+4723070000 ext 1936	anders.hartmann@rikshospitalet.no
Contact: Jens Bollerslev, MD, PhD	+4723070000	jens.bollerslev@rikshospitalet.no

Locations

Norway
Rikshospitalet-Radiumhospitalet Medical Center	Recruiting
Oslo, Norway, 0027

Sponsors and Collaborators

Smerud Medical Research International AS

Rikshospitalet HF

Investigators

Study Director:

Knut T Smerud, MSc

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

More Information

No publications provided

Responsible Party:	Smerud Medical Research International AS ( Knut Smerud )
Study ID Numbers:	SMR-1471, EUDRACT no.: 2006-003884-30
Study First Received:	January 17, 2007
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00423384 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Smerud Medical Research International AS:

Ibandronate
Placebo
Doubleblind
Bone

loss
Kidney
transplant

Additional relevant MeSH terms:

Ibandronic acid
Physiological Effects of Drugs
Bone Density Conservation Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010