NCT00423384

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 24, 2010

Status Verified

March 1, 2010

Enrollment Period

2.9 years

First QC Date

January 17, 2007

Last Update Submit

March 22, 2010

Conditions

Renal Transplant

Keywords

IbandronatePlaceboDoubleblindBonelossKidneytransplant

Outcome Measures

Primary Outcomes (1)

  • Difference in percent lumbar BMD change from baseline to 12 months between the two treatment groups.

    December 2010

Secondary Outcomes (10)

  • Lumbar BMD change; absolute and relative

    December 2010

  • Hip BMD change; absolute and relative

    December 2010

  • Radial BMD change; absolute and relative

    December 2010

  • Femural BMD change; absolute and relative

    December 2010

  • Change in height

    December 2010

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Ibandronate

Drug: Ibandronate

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

Placebo

2
IbandronateDRUG

I.v.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet-Radiumhospitalet Medical Center

Oslo, 0027, Norway

Location

Related Publications (1)

  • 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.

    PMID: 39588131DERIVED

MeSH Terms

Interventions

Ibandronic Acid

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Knut T Smerud, MSc

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2007

First Posted

January 18, 2007

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

March 24, 2010

Record last verified: 2010-03

Locations

NO(1)