Prosthesis LooseningPhase 3PTHNCT02744482
Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis
A Phase 3 study testing risedronate in people with Prosthesis Loosening, run by University Hospital, Limoges at 1 site in France.
Trial summary
This is an experimental study, prospective, comparative. This clinical trial is randomized and double-blind, Residronate versus placebo. The study aims to demonstrate the effectiveness of risedronate in pain management, after 18 month of traitment, in patients undergoing aseptic joint prosthesis loosening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis Loosening
- What is being tested?
- risedronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to 22 Mar 2018
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 years of age or older.
- Written informed consent
- Subjects with cemented or not cemented total hip prothesis (for primitive or secondary coxarthrosis)
- Painful aseptic loosening
- Subject has pain 4 or greater on a 10 point Visual Pain Rating scale
- For subject woman of reproductive age, they must use reliable method(s) of contraception and/or abstinence, for the duration of therapeutic product exposure.
Who cannot join
- Subjects with septic loosening of hip prosthesis
- . Subjects with bilateral disease
- Subjects with implant mobility associated with pre-operative and intraoperative loosening
- Subjects under anti-osteoporotic treatment
- Subjects having stopped a biphosphonate traetment for less than one year
- Subjects with known allergy or sensitivity to any of the components in the study medication.
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- Subjects with Hypocalcemia
- Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
- Subjects with severe kidney failure ( creatinine < 30 ml/min)).
- Subjects participation in another research study
- Subjects with previous osteonecrosis of the jaw
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo
This is an experimental study, prospective, comparative. This clinical trial is randomized and double-blind, Residronate versus placebo.
The study aims to demonstrate the effectiveness of risedronate in pain management, after 18 month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were compared with a 1: 1 ratio. The first group receives active drug (risedronate 75mg) and the second a placebo.
Patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive days each month.
Evaluations are planned evry 6 months.
- Conditions
- Prosthesis Loosening
- Being tested
- risedronate, placebo
- Medical subject headings
- Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risedronateDrug
risedrante tablet (75 mg)
placeboDrug
risedrante placebo tablet (75 mg)
| Study group | Role | What they receive |
|---|---|---|
| Risedronate | Experimental | Patients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months. Receives: Drug: risedronate |
| Placebo | Placebo comparator | Patients take an oral tablet of Placebo, 2 consecutive days per month during 18 months. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement
Measurement of pain by means of numerical rating scale.
Measured: 18, months
Secondary outcomes (2)
Pain measurement at walk
Measurement of pain by means of numerical rating scale
Measured: 6 months, 12 months, 18, months, 24 moths
Pain measurement at rest
Measurement of pain by means of numerical rating scale
Measured: 6 months, 12 months, 18, months, 24 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startMay 2016
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Why it stopped: lack of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis LooseningStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744482
- Sponsor's protocol ID
- I14005
- Acronym
- PTH
- Status last verified
- Oct 2018
- First submitted
- 13 Apr 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Risedronate in Patients With Painful Periprosthetic Resorption of the Hip Prothesis Double-blind Randomized Study Versus Placebo
- ClinicalTrials.gov ID
- NCT02744482
- Acronym / sponsor ID
- PTH / I14005
- Conditions
- Prosthesis Loosening
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 20 Apr 2016 (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.
This is an experimental study, prospective, comparative. This clinical trial is randomized and double-blind, Residronate versus placebo.
The study aims to demonstrate the effectiveness of risedronate in pain management, after 18 month of traitment, in patients undergoing aseptic joint prosthesis loosening. 2 groups were compared with a 1: 1 ratio. The first group receives active drug (risedronate 75mg) and the second a placebo.
Patients are treated during 18 months: 1 tablet residronate/placebo per os two consecutive days each month.
Evaluations are planned evry 6 months.
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 | Experimental | Drug: risedronatePatients take an oral tablet of Risedronate 75 mg, 2 consecutive days per month during 18 months. |
| Placebo | Placebo comparator | Drug: placeboPatients take an oral tablet of Placebo, 2 consecutive days per month during 18 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects, 18 years of age or older.
- Written informed consent
- Subjects with cemented or not cemented total hip prothesis (for primitive or secondary coxarthrosis)
- Painful aseptic loosening
- Subject has pain 4 or greater on a 10 point Visual Pain Rating scale
Key exclusion criteria (11 listed)
- Subjects with septic loosening of hip prosthesis
- . Subjects with bilateral disease
- Subjects with implant mobility associated with pre-operative and intraoperative loosening
- Subjects under anti-osteoporotic treatment
- Subjects having stopped a biphosphonate traetment for less than one year
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 |
|---|---|---|
| risedronaterisedrante tablet (75 mg) | Drug | Risedronate |
| placeborisedrante placebo tablet (75 mg) | Drug | Placebo |
Primary outcome
Pain measurement
Time frame: 18, months
Measurement of pain by means of numerical rating scale.
2 secondary outcomes
Pain measurement at walk
Time frame: 6 months, 12 months, 18, months, 24 moths
Pain measurement at rest
Time frame: 6 months, 12 months, 18, months, 24 moths
Results and safety
The study was stopped early (reason given: lack of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risedronate in people with Prosthesis Loosening, run by University Hospital, Limoges at 1 site in France.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 17 Oct 2018. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: lack of patients). Results are not available in the source record.
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?
Pain measurement (time frame: 18, months). 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 17 Oct 2018.