Bone LossPhase 4PREVENTNCT00772395
Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty
A Phase 4 study testing Risedronate in people with Bone Loss, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty? Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Bone Loss
- What is being tested?
- Risedronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2006to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on the waiting list for a total hip arthroplasty
- Primary osteoarthritis
- Osteoarthritis secondary to congenital dislocation of the hip
Who cannot join
- Rheumatoid arthritis
- Bisphosphonate treatment
- Osteomalacia
- Hypocalcemia
- Previous surgery of the affected hip
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Orthopaedic department, Danderyd Hospital
Stockholm, Stockholm County, 18288
About this study
Official title: Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?
Read the detailed description
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.
- Conditions
- Bone Loss
- Being tested
- Risedronate, Placebo
- Keywords
- Periprosthetic bone loss risedronate bisphosphonates
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisedronateDrug
35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months)
PlaceboDrug
Placebo given once weekly start on 2nd postoperative day for 26 weeks (6 months)
| Study group | Role | What they receive |
|---|---|---|
| Risedronate | Active comparator | Not described Receives: Drug: Risedronate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can risedronate given once weekly for 6 months prevent periprosthetic bone loss up to 2 years after uncemented total hip arthroplasty
Measured: 4 years
Secondary outcomes (1)
Can risedronate reduce migration of a uncemented femoral stem
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startApr 2006
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Olof Skoldenberg, Danderyd Hospital
- Investigators
- Olof G Sköldenberg, MD, Principal investigator, Department of clinical sciences at Danderyd hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772395
- Sponsor's protocol ID
- 04-745/4
- Other IDs
- 04-745/4
- Acronym
- PREVENT
- Status last verified
- Sep 2014
- First submitted
- 14 Oct 2008
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Risedronate Prevent Periprosthetic Bone Loss After Total Hip Arthroplasty. A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- ClinicalTrials.gov ID
- NCT00772395
- Acronym / sponsor ID
- PREVENT / 04-745/4
- Conditions
- Bone Loss
- Keywords
- Periprosthetic bone loss risedronate bisphosphonates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Apr 2006
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can risedronate given once weekly for 6 months prevent periprosthetic bone loss after uncemented total hip arthroplasty?
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risedronate | Active comparator | Drug: Risedronate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients on the waiting list for a total hip arthroplasty
- Primary osteoarthritis
- Osteoarthritis secondary to congenital dislocation of the hip
Key exclusion criteria (5 listed)
- Rheumatoid arthritis
- Bisphosphonate treatment
- Osteomalacia
- Hypocalcemia
- Previous surgery of the affected hip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risedronate35 mg given once weekly start on 2nd postoperative day for 26 weeks (6 months) | Drug | Risedronate |
| PlaceboPlacebo given once weekly start on 2nd postoperative day for 26 weeks (6 months) | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Can risedronate reduce migration of a uncemented femoral stem
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olof G Sköldenberg, MD principal investigator
Department of clinical sciences at Danderyd hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risedronate in people with Bone Loss, run by Danderyd Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.