Prosthetic Fixation After Cementless Total Hip ArthroplastyPhase 4NCT02333344
The Efficacy Study of Aclasta on Prosthetic Fixation in Postmenopausal Women After THA
A Phase 4 study testing Zoledronic acid 5mg in people with Prosthetic Fixation After Cementless Total Hip Arthroplasty, run by Novartis Pharmaceuticals at 1 site in China.
Trial summary
It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after 24-month observation. Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Prosthetic Fixation After Cementless Total Hip Arthroplasty
- What is being tested?
- Zoledronic acid 5mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2015to 28 Jan 2020
- 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 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who was diagnosed with Post-menopausal osteoporosis( bone mineral density T<-2.5;or with previous fragility fracture, bone mineral density T -2.5~-1.5), responding to Zoledronic acid, within one week after the successful cementless total hip arthroplasty surgery.
Who cannot join
- Patients with any history of disorders except osteoporosis known to severely affect bone and mineral metabolism such as Paget disease;
- Patients who suffer from secondary osteoporosis
- Patients who were treated with bisphosphonate within the previous one year ,anabolic drug or strontium;
- Patients with contraindications for Zoledronic acid:
- Patients with invasive malignant tumor on any organ in the past 5 years, treated oruntreated;
- Patients with primary hyperparathyroidism.
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- Serum calcium >2.75mmol/L (11.0mg/dL).
- Patients who are unwilling to accept the treatment of Zoledronic acid.
- Patients who accepted the treatment of investigational product and/or device in the 30 days before randomization.
- Patients with any medical or mental diseases, which prevent patients from complying with protocols or completing protocols, judged by investigators.
- Patients with the medical history of inflammation of the iris or uveitis, except the inflammation which is secondary to trauma and cured 2 years ago before screening.
- Patients with the medical history of diabetic nephropathy or diabetic retinopathy.
- Patients aged under 60 years old and whose result of urine pregnancy test paper is positive.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy Study of Aclasta (Zoledronic Acid 5mg) on Prosthetic Fixation in Postmenopausal Women After Cementless Total Hip Arthroplasty (THA): a 24 Months, Single Center, Open- Label, Randomized, Parallel Controlled Study
It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after 24-month observation.
Read the detailed description
To investigate the efficacy of Zoledronic acid and placebo treatment on the prosthetic transverse translation in post-menopausal osteoporosis women under cementless total hip arthroplasty by Radiostereometry （RSA）in two-year follow-up period .
Meanwhile to assess efficacy of Zoledronic acid treatment on the vertical translation of acetabulum and the subsidence translation of femoral stem by Radiostereometry（RSA), prevention of peri- prosthetic bone loss by observing the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry (DXA）scans, et al.
- Being tested
- Zoledronic acid 5mg
- Keywords
- prosthetic fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acid 5mgDrug
Also called aclasta
two-year Zoledronic acid 5mg infusion treatment
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid 5mg | Experimental | interventional group which receive yearly Zoledronic acid 5mg/100ml infusion treatment for two years Receives: Drug: Zoledronic acid 5mg |
| blank | No intervention | blank group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the transverse translation (μm)
the transverse translation (μm, outside-inside) between acetabular prosthesis markers and reference point
Measured: baseline and month12,month 24
Secondary outcomes (1)
average bone mineral density ( BMD )
the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry （DXA）scans.
Measured: 1w,6m,12m and 24m after THA operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start30 Jul 2015
- Primary completion28 Jan 2020 (estimated)
- Study completion28 Jan 2020 (estimated)
Why it stopped: Study halted prematurely, prior to enrollment of first participant, for strategic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Fixation After Cementless Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333344
- Sponsor's protocol ID
- CZOL446HCN13
- Status last verified
- Sep 2019
- First submitted
- 12 Oct 2014
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy Study of Aclasta (Zoledronic Acid 5mg) on Prosthetic Fixation in Postmenopausal Women After Cementless Total Hip Arthroplasty (THA): a 24 Months, Single Center, Open- Label, Randomized, Parallel Controlled Study
- ClinicalTrials.gov ID
- NCT02333344
- Acronym / sponsor ID
- CZOL446HCN13
- Keywords
- prosthetic fixation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study halted prematurely, prior to enrollment of first participant, for strategic reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2015 (actual)
- Primary completion
- 28 Jan 2020 (estimated)
- Study completion
- 28 Jan 2020 (estimated)
- First posted
- 7 Jan 2015 (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.
It's to investigate the efficacy of Zoledronic acid treatment on the early prosthetic fixation in post-menopausal osteoporosis women under cementless total hip arthroplasty after 24-month observation.
Detailed description
To investigate the efficacy of Zoledronic acid and placebo treatment on the prosthetic transverse translation in post-menopausal osteoporosis women under cementless total hip arthroplasty by Radiostereometry （RSA）in two-year follow-up period .
Meanwhile to assess efficacy of Zoledronic acid treatment on the vertical translation of acetabulum and the subsidence translation of femoral stem by Radiostereometry（RSA), prevention of peri- prosthetic bone loss by observing the local average bone mineral density ( BMD ) changes for 7 femoral region Gruen zones through Dual Energy X-ray Absorptiometry (DXA）scans, et al.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid 5mg | Experimental | Drug: Zoledronic acid 5mginterventional group which receive yearly Zoledronic acid 5mg/100ml infusion treatment for two years |
| blank | No intervention | –blank group |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who was diagnosed with Post-menopausal osteoporosis( bone mineral density T<-2.5;or with previous fragility fracture, bone mineral density T -2.5~-1.5), responding to Zoledronic acid, within one week after the successful cementless total hip arthroplasty surgery.
Key exclusion criteria (14 listed)
- Patients with any history of disorders except osteoporosis known to severely affect bone and mineral metabolism such as Paget disease;
- Patients who suffer from secondary osteoporosis
- Patients who were treated with bisphosphonate within the previous one year ,anabolic drug or strontium;
- Patients with contraindications for Zoledronic acid:
- Patients with invasive malignant tumor on any organ in the past 5 years, treated oruntreated;
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 |
|---|---|---|
| Zoledronic acid 5mgAlso: aclastatwo-year Zoledronic acid 5mg infusion treatment | Drug | Zoledronic acid 5mg |
Primary outcome
the transverse translation (μm)
Time frame: baseline and month12,month 24
the transverse translation (μm, outside-inside) between acetabular prosthesis markers and reference point
1 secondary outcome
average bone mineral density ( BMD )
Time frame: 1w,6m,12m and 24m after THA operation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Zoledronic acid 5mg in people with Prosthetic Fixation After Cementless Total Hip Arthroplasty, run by Novartis Pharmaceuticals at 1 site in China.
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 1 inclusion and 14 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: withdrawn, as of the sponsor's last update on 16 Sep 2019. 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 China. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
the transverse translation (μm) (time frame: baseline and month12,month 24). 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 16 Sep 2019.