OsteoporosisPhase 4LISANCT00745485
Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid
A Phase 4 study testing zoledronic acid in people with Osteoporosis, run by Novartis Pharmaceuticals at 14 sites in Australia.
Trial summary
1. The study will assess the safety and tolerability of a single-infusion of zoledronic acid 5 mg administered in a private medical practice setting by a nurse provided by a nationwide infusion service. Safety data will largely be monitored by investigating changes in the patients' well-being during the study. 2. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- zoledronic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 14 sitesAustralia
- Study dates
- Aug 2008to Jul 2010
- 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 1. Female after menopause with osteoporosis either: 70 years of age or older with a bone mineral density T-score of -3.0 or less OR with a fracture due to minimal trauma.
Who cannot join
- Intravenous bisphosphonate within the past 12 months
- Abnormal levels of protein in the urine via dipstick at screening if not caused by bacterial infection
- Abnormal liver function tests greater than twice normal
- Evidence of high bone turnover
- Abnormal calcium blood levels
- Low Vitamin D levels
Show all 14Show fewer
- Poor renal function
- Abnormal parathyroid function or uncontrolled, abnormal thyroid function
- History of eye inflammation
- History of diabetes leading to kidney or eye problems
- A history of cancer except some non-invasive cancers of skin, colon, breast and cervix
- Patients with severe dental problems or current dental infections Or requiring dental surgery
- Known sensitivity to zoledronic acid or bisphosphonates
- Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Australia14 sites
Novartis Investigative Site
Ashford, South Australia, 5035
Novartis Investigative Site
Blacktown, New South Wales, 2148
Novartis Investigative Site
Caloundra, Queensland, 4551
Novartis Investigative Site
Footscray, Victoria, 3011
Novartis Investigative Site
Georgetown, New South Wales, 2298
Novartis Investigative Site
Leichhardt, New South Wales, 2040
Novartis Investigative Site
Manly, New South Wales, 2095
Novartis Investigative Site
Nedlands, WA 6009
Novartis Investigative Site
Nedlands Perth, 6009
Novartis Investigative Site
North Parramatta, New South Wales, 2150
Novartis Investigative Site
Norwood, South Australia, 5067
Novartis Investigative Site
Ringwood, Victoria, 3134
Novartis Investigative Site
Southport, Queensland, 4215
Novartis Investigative Site
Wentworthville, New South Wales, 2150
About this study
Official title: A Phase IV Study of the Safety and Feasibility of Rooms-based Infusion of Zoledronic Acid for Women With Post-menopausal Osteoporosis
- The study will assess the safety and tolerability of a single-infusion of zoledronic acid 5 mg administered in a private medical practice setting by a nurse provided by a nationwide infusion service. Safety data will largely be monitored by investigating changes in the patients' well-being during the study.
- The study will pilot and test a Patient Registry and Infusion Service process, which will allow zoledronic acid to be administered to trial patients in the investigators' private rooms by a team of roving nurses.
- Conditions
- Osteoporosis
- Being tested
- zoledronic acid
- Keywords
- Osteoporosis, zoledronic acid, postmenopausal women
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Zoldronic | Experimental | Not described Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Measured: at baseline and month 12
Bone turnover
Measured: at baseline and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis PharmaceuticalsNovartis Pharmaceuticals, Principal investigator, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745485
- Sponsor's protocol ID
- CZOL446HAU27
- Acronym
- LISA
- Status last verified
- Feb 2017
- First submitted
- 1 Sep 2008
- Last updated
- 27 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study of the Safety and Feasibility of Rooms-based Infusion of Zoledronic Acid for Women With Post-menopausal Osteoporosis
- ClinicalTrials.gov ID
- NCT00745485
- Acronym / sponsor ID
- LISA / CZOL446HAU27
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, zoledronic acid, postmenopausal women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (actual)
- First posted
- 3 Sep 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.
- The study will assess the safety and tolerability of a single-infusion of zoledronic acid 5 mg administered in a private medical practice setting by a nurse provided by a nationwide infusion service. Safety data will largely be monitored by investigating changes in the patients' well-being during the study.
- The study will pilot and test a Patient Registry and Infusion Service process, which will allow zoledronic acid to be administered to trial patients in the investigators' private rooms by a team of roving nurses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zoldronic | Experimental | Drug: zoledronic acid |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 1. Female after menopause with osteoporosis either: 70 years of age or older with a bone mineral density T-score of -3.0 or less OR with a fracture due to minimal trauma.
Key exclusion criteria (14 listed)
- Intravenous bisphosphonate within the past 12 months
- Abnormal levels of protein in the urine via dipstick at screening if not caused by bacterial infection
- Abnormal liver function tests greater than twice normal
- Evidence of high bone turnover
- Abnormal calcium blood levels
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 | Drug | Zoldronic |
Primary outcome
Bone Mineral Density
Time frame: at baseline and month 12
Bone turnover
Time frame: at baseline and month 12
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 27 Feb 2017.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Novartis Pharmaceuticals principal investigator
Novartis Pharmaceuticals
14 sites 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 in people with Osteoporosis, run by Novartis Pharmaceuticals at 14 sites in Australia.
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: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Australia. 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 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 (time frame: at baseline and month 12). The study lists 2 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 27 Feb 2017.