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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
Scientific title
The tolerability and efficacy of generic alendronate in older women: a randomized trial
Secondary ID [1] 282136 0
Nil
Universal Trial Number (UTN)
U1111-1136-7477
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 288635 0
Condition category
Condition code
Musculoskeletal 288974 288974 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 286743 0
Treatment: Drugs
Intervention code [2] 286783 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 289096 0
Change in serum beta-C telopeptides
Timepoint [1] 289096 0
3 months
Primary outcome [2] 289097 0
Tolerability, assessed by adverse events collection
Adverse events will be ascertained by administration of the Generic Assessment of Side Effects (GASE) symptom checklist
Timepoint [2] 289097 0
3 months
Secondary outcome [1] 301770 0
Nil
Timepoint [1] 301770 0
N/A

Eligibility
Key inclusion criteria
Female >60y
Minimum age
60 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
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

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)
Participants recruited by electoral roll mail out
Central randomization by computer
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
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4942 0
New Zealand
State/province [1] 4942 0
Auckland

Funding & Sponsors
Funding source category [1] 286905 0
Government body
Name [1] 286905 0
Health Research Council of New Zealand
Address [1] 286905 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 286905 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 285693 0
None
Name [1] 285693 0
None
Address [1] 285693 0
N/A
Country [1] 285693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288964 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 288964 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288964 0
New Zealand
Date submitted for ethics approval [1] 288964 0
Approval date [1] 288964 0
15/02/2013
Ethics approval number [1] 288964 0
12/NTA/94

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38546 0
A/Prof Andrew Grey
Address 38546 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 38546 0
New Zealand
Phone 38546 0
+64 9 9234423
Fax 38546 0
+64 9 3737677
Email 38546 0
a.grey@auckland.ac.nz
Contact person for public queries
Name 38547 0
Dr Anne Horne
Address 38547 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 38547 0
New Zealand
Phone 38547 0
+64 9 9239787
Fax 38547 0
+64 9 3737677
Email 38547 0
a.horne@auckland.ac.nz
Contact person for scientific queries
Name 38548 0
A/Prof Andrew Grey
Address 38548 0
Department of Medicine
University of Auckland
Private Bag 92019
Auckland 1142
Country 38548 0
New Zealand
Phone 38548 0
+64 9 9234423
Fax 38548 0
+64 9 3737677
Email 38548 0
a.grey@auckland.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary