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Completed

NCT Number: NCT00772395

Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty

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

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Orthopaedic department, Danderyd Hospital

Stockholm, Stockholm County, 18288, Sweden

About this study

Periprosthetic bone loss after total hip arthroplasty is the main factor in limiting the longevity of implants used for treatment of osteoarthritis. Bone loss leads to implant destabilization. Bisphosphonates, given for approximately 6 months after THA man prevent this bone loss and lead to longer implant fixation and lower incidence of aseptic prosthesis loosening. We perform a clinical trial with risedronate to investigate if we can influence periprosthetic bone loss around a uncemented femoral stem.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

risedronate

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 4 years

Secondary outcomes

  1. Can risedronate reduce migration of a uncemented femoral stem

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Collaborators

  • Sanofi

Registry information

Official study title

Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study

Acronym: PREVENT

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Oct 15, 2008
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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