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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00745485




Registration number
NCT00745485
Ethics application status
Date submitted
1/09/2008
Date registered
3/09/2008
Date last updated
27/02/2017

Titles & IDs
Public title
Feasibility of Doctors' Rooms-based Infusion of Zoledronic Acid
Scientific title
A Phase IV Study of the Safety and Feasibility of Rooms-based Infusion of Zoledronic Acid for Women With Post-menopausal Osteoporosis
Secondary ID [1] 0 0
CZOL446HAU27
Universal Trial Number (UTN)
Trial acronym
LISA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - zoledronic acid

Experimental: Zoldronic -


Treatment: Drugs: zoledronic acid
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bone Mineral Density
Timepoint [1] 0 0
at baseline and month 12
Primary outcome [2] 0 0
Bone turnover
Timepoint [2] 0 0
at baseline and month 12

Eligibility
Key inclusion criteria
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.
Minimum age
70 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intravenous bisphosphonate within the past 12 months

2. Abnormal levels of protein in the urine via dipstick at screening if not caused by
bacterial infection

3. Abnormal liver function tests greater than twice normal

4. Evidence of high bone turnover

5. Abnormal calcium blood levels

6. Low Vitamin D levels

7. Poor renal function

8. Abnormal parathyroid function or uncontrolled, abnormal thyroid function

9. History of eye inflammation

10. History of diabetes leading to kidney or eye problems

11. A history of cancer except some non-invasive cancers of skin, colon, breast and cervix

12. Patients with severe dental problems or current dental infections Or requiring dental
surgery

13. Known sensitivity to zoledronic acid or bisphosphonates

Other protocol defined inclusion/exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
186
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Blacktown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Georgetown
Recruitment hospital [3] 0 0
Novartis Investigative Site - Leichhardt
Recruitment hospital [4] 0 0
Novartis Investigative Site - Manly
Recruitment hospital [5] 0 0
Novartis Investigative Site - North Parramatta
Recruitment hospital [6] 0 0
Novartis Investigative Site - Wentworthville
Recruitment hospital [7] 0 0
Novartis Investigative Site - Caloundra
Recruitment hospital [8] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [9] 0 0
Novartis Investigative Site - Ashford
Recruitment hospital [10] 0 0
Novartis Investigative Site - Norwood
Recruitment hospital [11] 0 0
Novartis Investigative Site - Footscray
Recruitment hospital [12] 0 0
Novartis Investigative Site - Ringwood
Recruitment hospital [13] 0 0
Novartis Investigative Site - Nedlands Perth
Recruitment hospital [14] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2298 - Georgetown
Recruitment postcode(s) [3] 0 0
2040 - Leichhardt
Recruitment postcode(s) [4] 0 0
2095 - Manly
Recruitment postcode(s) [5] 0 0
2150 - North Parramatta
Recruitment postcode(s) [6] 0 0
2150 - Wentworthville
Recruitment postcode(s) [7] 0 0
4551 - Caloundra
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment postcode(s) [9] 0 0
5035 - Ashford
Recruitment postcode(s) [10] 0 0
5067 - Norwood
Recruitment postcode(s) [11] 0 0
3011 - Footscray
Recruitment postcode(s) [12] 0 0
3134 - Ringwood
Recruitment postcode(s) [13] 0 0
6009 - Nedlands Perth
Recruitment postcode(s) [14] 0 0
WA 6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00745485
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00745485