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Trial registered on ANZCTR
Registration number
ACTRN12613000329763
Ethics application status
Approved
Date submitted
22/03/2013
Date registered
25/03/2013
Date last updated
3/11/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
The tolerability and efficacy of generic alendronate in older women: a randomized trial
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Scientific title
The tolerability and efficacy of generic alendronate in older women: a randomized trial
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Secondary ID [1]
282136
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Nil
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Universal Trial Number (UTN)
U1111-1136-7477
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Trial acronym
Nil
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoporosis
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Condition category
Condition code
Musculoskeletal
288974
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0
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Osteoporosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
There were 2 randomizations, ie a 2x2 factorial trial:
One randomization was to receiving generic alendronate 70mg weekly per oral for 3 months or proprietary alendronate 70mg weekly per oral for 3 months
The second randomization was to being informed of taking, either generic alendronate 70mg weekly or proprietary alendronate 70mg weekly per oral for 3 months. Participants were informed verbally by research staff and by labeling on medication container.
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Intervention code [1]
286743
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Treatment: Drugs
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Intervention code [2]
286783
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Prevention
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Comparator / control treatment
There were 2 randomizations, ie a 2x2 factorial trial:
One randomization was to receiving generic alendronate 70mg weekly per oral for 3 months or proprietary alendronate 70mg weekly per oral for 3 months
The second randomization was to being informed of taking, either generic alendronate 70mg weekly or proprietary alendronate 70mg weekly per oral for 3 months. Participants were informed verbally by research staff and by labeling on medication container.
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Control group
Active
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Outcomes
Primary outcome [1]
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Change in serum beta-C telopeptides
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Assessment method [1]
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Timepoint [1]
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3 months
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Primary outcome [2]
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Tolerability, assessed by adverse events collection
Adverse events will be ascertained by administration of the Generic Assessment of Side Effects (GASE) symptom checklist
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Assessment method [2]
289097
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Timepoint [2]
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3 months
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Timepoint [1]
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N/A
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Eligibility
Key inclusion criteria
Female >60y
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Medical Conditions
- severe renal impairment (eGFR < 30ml/min from review of previous blood tests).
- chronic liver disease.
- untreated thyroid dysfunction.
- current malignancy except for adequately treated BCC, SCC or Cervical CIS.
- Paget’s disease of bone.
Medications
- use of oral glucocorticoid drugs equivalent to an average dose of prednisone 2.5 mg/day in the preceding 12 months
- use of oral aminobisphosphonates within the past 3 years, etidronate within the past 1 year, or zoledronate ever
- use of estrogen replacement therapy within the last 12 months
- use of other medication known to affect bone metabolism
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants recruited by electoral roll mail out
Central randomization by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A pseudo random number was generated for 200 potential participants using Microsoft Excel (2010). Within blocks of variable size (8-16) the random numbers were sorted and those potential participants within each rank quartile were allocated to separate treatment/information groups
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Factorial
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Two primary analyses will be undertaken:
i. An evaluation of tolerability will be undertaken by comparing the proportion of participants who report at least one adverse event in the treatment groups, using Fisher’s exact test. Tolerability will also be evaluated by comparing symptom scores in the treatment groups. These scores are likely to be non-parametrically distributed and therefore a Wilcoxon independent groups test will be performed. Further analysis will compare symptom severity scores between treatment groups.
ii. An evaluation of efficacy will be undertaken by comparing change in beta-CTX at 3 months in the treatment groups.
For both tolerability and efficacy equivalence intervals will be calculated for each endpoint and formal tests of equivalence performed by testing two sets of one-sided hypotheses.
All tests will be two tailed and a 5% significance level maintained. Data analyses will be performed on an intention-to-treat basis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/05/2013
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Actual
7/10/2013
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Date of last participant enrolment
Anticipated
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Actual
13/12/2014
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Date of last data collection
Anticipated
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Actual
18/12/2015
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Sample size
Target
200
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Accrual to date
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Final
197
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Health Research Council of New Zealand
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Address [1]
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PO Box 5541, Wellesley Street, Auckland 1141
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Private Bag 92019
Auckland 1142
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
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N/A
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Country [1]
285693
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Northern A Health and Disability Ethics Committee
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Ethics committee address [1]
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Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6011
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
288964
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Approval date [1]
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15/02/2013
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Ethics approval number [1]
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12/NTA/94
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Summary
Brief summary
This is a 3 month prospective randomized 2x2 factorial trial of generic vs proprietary alendronate. 200 participants meeting the admission criteria will be randomly and equally allocated to 4 treatment groups, according to formulation of trial medication (proprietary or generic) and knowledge of formulation (proprietary or generic). Subjects will undergo baseline assessments of medication sensitivity, symptoms, and biochemical markers of bone turnover. Symptom scores will be measured at 2, 6 and 12 weeks. Markers of bone turnover will be measured at 12 weeks. Adherence self-report and tablet counts will be undertaken at the conclusion of the trial.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Andrew Grey
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Address
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Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 9234423
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Fax
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+64 9 3737677
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Anne Horne
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Address
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Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 9239787
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Fax
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+64 9 3737677
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Email
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Andrew Grey
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Address
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Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
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Country
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New Zealand
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Phone
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+64 9 9234423
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Fax
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+64 9 3737677
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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