NCT00772395

Brief Summary

Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2006

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

6.8 years

First QC Date

October 14, 2008

Last Update Submit

September 18, 2014

Conditions

Bone Loss

Keywords

Periprosthetic bone loss risedronate bisphosphonates

Outcome Measures

Primary Outcomes (1)

  • Can risedronate given once weekly for 6 months prevent periprosthetic bone loss up to 2 years after uncemented total hip arthroplasty

    4 years

Secondary Outcomes (1)

  • Can risedronate reduce migration of a uncemented femoral stem

    4 years

Study Arms (2)

Risedronate

ACTIVE COMPARATOR
Drug: Risedronate

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

RisedronateDRUG

35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)

Risedronate
PlaceboDRUG

Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)

Placebo

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients on the waiting list for a total hip arthroplasty
  • Primary osteoarthritis
  • Osteoarthritis secondary to congenital dislocation of the hip

You may not qualify if:

  • Rheumatoid arthritis
  • Bisphosphonate treatment
  • Osteomalacia
  • Hypocalcemia
  • Previous surgery of the affected hip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic department, Danderyd Hospital

Stockholm, Stockholm County, 18288, Sweden

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Olof G Sköldenberg, MD

    Department of clinical sciences at Danderyd hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consulatant Orthopaedic Surgeon

Study Record Dates

First Submitted

October 14, 2008

First Posted

October 15, 2008

Study Start

April 1, 2006

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

SE(1)