Prevention of BMD Loss After THRPhase 3NCT02838121
Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy
A Phase 3 study testing Aclasta in people with Prevention of BMD Loss After THR and Serum Markers of Bone Turnover, run by Mel Shiuann-Sheng Lee at 1 site in Taiwan.
Trial summary
Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy under mechanical unloading after THR implantation, further compromises the longevity of implant. The prospective randomized study is aimed to investigate the periprosthetic bone loss after primary total hip replacements. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Prevention of BMD Loss After THR, Serum Markers of Bone Turnover, Functional Outcomes
- What is being tested?
- Aclasta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2009to Jun 2016
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female,between 35 and 85 years of age
- Indicated for Total hip replacement for various hip diseases
- Has preoperative DXA study within 3 months before the total hip replacement procedure or willing to receive preoperative DXA study as a baseline comparison
- Signed written informed consent
- Standard transgluteal approach for total hip replacement using Zimmer Triology Cup and Versys Fiber Metal Taper Stem with metal to highly cross-linked polyethylene bearing surface
Who cannot join
- Any prior use of intravenous bisphosphonate within the last 2 years
- Uncontrolled seizure disorders associated with falls
- A history of invasive malignancy of any organ system, treated or untreated, within the past five years; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed
- Carcinoma in situ of the uterine cervix
- History of osteogenesis imperfecta, multiple myeloma, or Paget's disease
- Active primary hyperparathyroidism
Show all 17Show fewer
- History of iritis or uveitis
- Self-reported history of diabetic nephropathy or retinopathy
- AST or ALT more than twice the upper limit of normal
- Alkaline phosphatase more than twice the upper limit of normal
- Serum calcium 2.75 mmol/L (11.0 mg/dL)
- Baseline renal insufficiency (calculated creatinine clearance 35 ml/min)
- History of hypersensitivity to bisphosphonates
- Use of any investigational drug(s) and/or devices within 30 days prior to randomization
- Any medical or psychiatric condition which, in the Investigator's opinion, would preclude the participant from adhering to the Protocol or completing the trial per protocol
- Use of hip protectors
- With implant or prosthesis on the contralateral hip joint
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation on the Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy: A Prospective Randomized Clinical Trial
Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy under mechanical unloading after THR implantation, further compromises the longevity of implant. The prospective randomized study is aimed to investigate the periprosthetic bone loss after primary total hip replacements.
Read the detailed description
This study is a prospective, randomized, open-label clinical trial. The study will be performed in patients after obtaining informed consent. Group assignment is by drawing a sealed envelops based on random table. (1) Group 1: Experimental group 30 cases, Aclasta® (Zoledronic acid 5mg/100ml) is given intravenously on the 4th postoperative day and one year after the total hip replacement, (2) Group 2: Control group, 30 cases, no bisphosphonate is given to the patients. Only the unilateral coxarthrosis will be recruited for the study. Patients will be analyzed with (1) DXA study (2) Clinical assessment (Harris hip score and SF-12) (3) X-ray (4) serum marker of bone turnover. Patients will be scheduled for specified examinations preoperatively, postoperatively 6 weeks, 3 months, 6 months, 12 months, and 24 months.
- Being tested
- Aclasta, Placebo
- Keywords
- bisphosphonate, Total hip replacement, functional outcomes, bone mineral density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AclastaDrug
Aclasta once annually for 2 years
PlaceboDrug
No IV aclasta
| Study group | Role | What they receive |
|---|---|---|
| Aclasta | Experimental | Aclasta IV once annual for 2 years Receives: Drug: Aclasta |
| Placebo | Placebo comparator | Placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density [g/cm2] of the 7 Gruen zones
bone mineral density measured by dual energy x-ray absorptiometry
Measured: 5 years
bone mineral density change relative to the baseline values of the 7 Gruen zones
bone mineral density measured by dual energy x-ray absorptiometry
Measured: 5 years
implant loosening or migration
check the implant position by serial standard X ray follow-up
Measured: 5 years
Secondary outcomes (11)
serum alkaline phosphatase
Measured: 5 years
serum calcium level
Measured: 5 years
serum phosphate level
Measured: 5 years
serum osteocalcin level
Measured: 5 years
serum N-telopeptide procollagen level
Measured: 5 years
serum creatinine level
renal function and glomerular filtration rate
Measured: 5 years
serum alanine aminotransferase level
liver function
Measured: 5 years
serum aspartate aminotransferase level
liver function
Measured: 5 years
harris hip score
hip function measurement
Measured: 5 years
short form-12
life quality measurement
Measured: 5 years
University of California Los Angeles Activity Score
functional and activity evaluation, 10 point scale
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startDec 2009
- Primary completionJan 2013
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of BMD Loss After THRStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mel Shiuann-Sheng Lee
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor-investigator, Mel Shiuann-Sheng Lee, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838121
- Sponsor's protocol ID
- 98-1150A3
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2016
- Last updated
- 20 Jul 2016
- 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 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Prevention of Periprosthetic Bone Loss After Total Hip Replacement by Annual Bisphosphonate Therapy: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02838121
- Acronym / sponsor ID
- 98-1150A3
- Keywords
- bisphosphonate, Total hip replacement, functional outcomes, bone mineral density
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Mel Shiuann-Sheng LeeUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Dec 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Jul 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.
Periprosthetic bone loss caused by stress-shielding effect, a phenomenon of bone atrophy under mechanical unloading after THR implantation, further compromises the longevity of implant. The prospective randomized study is aimed to investigate the periprosthetic bone loss after primary total hip replacements.
Detailed description
This study is a prospective, randomized, open-label clinical trial. The study will be performed in patients after obtaining informed consent. Group assignment is by drawing a sealed envelops based on random table. (1) Group 1: Experimental group 30 cases, Aclasta® (Zoledronic acid 5mg/100ml) is given intravenously on the 4th postoperative day and one year after the total hip replacement, (2) Group 2: Control group, 30 cases, no bisphosphonate is given to the patients. Only the unilateral coxarthrosis will be recruited for the study. Patients will be analyzed with (1) DXA study (2) Clinical assessment (Harris hip score and SF-12) (3) X-ray (4) serum marker of bone turnover. Patients will be scheduled for specified examinations preoperatively, postoperatively 6 weeks, 3 months, 6 months, 12 months, and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aclasta | Experimental | Drug: AclastaAclasta IV once annual for 2 years |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo group |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female,between 35 and 85 years of age
- Indicated for Total hip replacement for various hip diseases
- Has preoperative DXA study within 3 months before the total hip replacement procedure or willing to receive preoperative DXA study as a baseline comparison
- Signed written informed consent
- Standard transgluteal approach for total hip replacement using Zimmer Triology Cup and Versys Fiber Metal Taper Stem with metal to highly cross-linked polyethylene bearing surface
Key exclusion criteria (17 listed)
- Any prior use of intravenous bisphosphonate within the last 2 years
- Uncontrolled seizure disorders associated with falls
- A history of invasive malignancy of any organ system, treated or untreated, within the past five years; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed
- Carcinoma in situ of the uterine cervix
- History of osteogenesis imperfecta, multiple myeloma, or Paget's disease
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 |
|---|---|---|
| AclastaAclasta once annually for 2 years | Drug | Aclasta |
| PlaceboNo IV aclasta | Drug | Placebo |
Primary outcome
bone mineral density [g/cm2] of the 7 Gruen zones
Time frame: 5 years
bone mineral density measured by dual energy x-ray absorptiometry
bone mineral density change relative to the baseline values of the 7 Gruen zones
Time frame: 5 years
bone mineral density measured by dual energy x-ray absorptiometry
implant loosening or migration
Time frame: 5 years
check the implant position by serial standard X ray follow-up
11 secondary outcomes
serum alkaline phosphatase
Time frame: 5 years
serum calcium level
Time frame: 5 years
serum phosphate level
Time frame: 5 years
serum osteocalcin level
Time frame: 5 years
serum N-telopeptide procollagen level
Time frame: 5 years
serum creatinine level
Time frame: 5 years
serum alanine aminotransferase level
Time frame: 5 years
serum aspartate aminotransferase level
Time frame: 5 years
harris hip score
Time frame: 5 years
short form-12
Time frame: 5 years
University of California Los Angeles Activity Score
Time frame: 5 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 20 Jul 2016.
- Chang Gung Memorial HospitalLink provided by the sponsor.
- American Academy of Orthopaedic SurgeonsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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 Aclasta in people with Prevention of BMD Loss After THR and Serum Markers of Bone Turnover, run by Mel Shiuann-Sheng Lee at 1 site in Taiwan.
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 5 inclusion and 17 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 20 Jul 2016. 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 Taiwan. 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 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?
bone mineral density [g/cm2] of the 7 Gruen zones (time frame: 5 years). The study lists 3 primary outcomes in all. 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 20 Jul 2016.