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Trial registered on ANZCTR


Registration number
ACTRN12621001111864
Ethics application status
Approved
Date submitted
26/07/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Falls Precede Fractures: Examining the Effects of an Online Exercise Program in People with an Osteoporotic Fracture
Scientific title
Falls Precede Fractures: Examining the Effects of an Online Exercise Program on Bone Mineral Density, Physical Function, Age-related Muscle Loss (Sarcopaenia) and Endocrine Correlates in Patients with Osteoporosis and Minimal Trauma Fracture
Secondary ID [1] 304881 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 323009 0
Minimal Trauma Fracture 323010 0
Condition category
Condition code
Musculoskeletal 320572 320572 0 0
Osteoporosis
Physical Medicine / Rehabilitation 320750 320750 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with osteoporosis and a previous minimal trauma fracture will be randomly allocated to one of two treatment arms: 1) usual care for individuals with osteoporotic fractures. This involves pharmacologic intervention, specifically bisphosphonates for this age group (55-75 years), and education on engaging in bone-promoting activities within their lifestyle; 2) usual care for individuals with osteoporotic fractures, including pharmacologic intervention as well as, participating in a 6-month online exercise program.

The pharmacologic intervention will encompass standard medication given to patients with osteoporosis and minimal trauma fracture. This includes antiresorptive agents (5mg zoledronic acid administered intravenously once per year), vitamin D supplementation if levels are <50 nmol/L, or calcium supplementation if required. The study physician will determine the requirement for pharmacologic intervention. Compliance to pharmacologic intervention will be determined through a follow-up phone call initially (2 months after treatment initiation) and via patient medical interviews at follow-up assessments (6 months, 12 months, and 24 months).

The education component will involve all participants being given an information resource that outlines the benefits of exercise in relation to osteoporosis, and provides a general overview of the exercise modalities most suitable for bone health (weight-bearing exercise, strength training and balance training). It also contains some points on safety considerations and activities that are not conducive to bone health (e.g. nonweight-bearing aerobic exercise). This information resource is designed as a 2 page fact sheet and will be handed to participants during the study’s baseline assessment.

The online exercise intervention will be delivered in real-time by an Accredited Exercise Physiologist, and will occur 2 times per week, with each session being 45 minutes in length. These classes will be designed to incorporate strength-based exercises, impact training and balance exercises to address the recommended national guidelines for exercise and osteoporosis. Considering the exercise program will be performed within the participants’ home environment, ensuring safety during exercise sessions will be paramount. The program will be set at moderate intensity (using the RPE 1-10 scale). The types of exercises included in the program will be strength-based (body weight and band exercises, e.g. sit-to-stands, standing hip abduction/extension, calf raises, incline push-ups, band pull-aparts, triceps extension), include moderate impact loading (e.g. heel drops, step-ups), and balance exercises (e.g. tandem stance, single leg stance). Regressions and progressions of each exercise will be instructed as an option for participants to engage in that is suited to their level. Attendance to the online exercise sessions will be recorded and used as a means to monitor adherence.
Intervention code [1] 321275 0
Rehabilitation
Intervention code [2] 321276 0
Lifestyle
Comparator / control treatment
Patients with osteoporosis alone will form the study’s control group. These patients will receive usual care for individuals with osteoporosis without a fragility fracture, which involves education on osteoporosis and how to adopt bone-promoting activities within their lifestyle. The same education intervention involving the information resource described above will be delivered to all groups (both treatment arms and the control group).
Control group
Active

Outcomes
Primary outcome [1] 328390 0
Change in absolute bone mineral density (g/cm2) measured via dual-energy x-ray absorptiometry (DEXA).
Timepoint [1] 328390 0
Bone mineral density will be measured at baseline and 1 year follow-up.
Secondary outcome [1] 398876 0
Proportion of participants who have re-fractured, determined through patient interview at follow-up assessments (6 months, 12 months, and 24 months).
Timepoint [1] 398876 0
Information on fracture incidence will be collected at baseline and follow-up timepoints (6 months, 12 months, and 24 months).
Secondary outcome [2] 398877 0
Change in physical function measured via a battery of physical function tests (Short Performance Physical Battery, Timed Up and Go Test, Five Times Sit to Stand Test, and handgrip strength test), forming a composite score.
Timepoint [2] 398877 0
Physical function will be assessed at four specified timepoints: baseline, 6 months, 12 months, and 24 months.
Secondary outcome [3] 398879 0
Changes in body composition (fat mass and lean mass), forming a composite score, determined via DEXA measurement.
Timepoint [3] 398879 0
Body composition will be measured at four specified timepoints: baseline, 6 months, 12 months, and 24 months.
Secondary outcome [4] 398880 0
Changes in endocrine correlates (calcium, phosphate, vitamin C, thyroid stimulating hormone, parathyroid hormone, vitamin D, procollagen type 1 N propeptide, C-terminal telopeptide of type 1 collagen, and estimated glomerular filtration rate) measured via blood collection.
Timepoint [4] 398880 0
Endocrine correlates will be measured at four specified timepoints: baseline, 6 months, 12 months, and 24 months.

Eligibility
Key inclusion criteria
The inclusion criteria consists of:
1. Osteoporosis diagnosis;
2. Aged 55-75 years;
3. History of one minimal trauma fracture that has fully healed (treatment groups only);
4. At least six months post-fracture (treatment groups only); and
5. Patients presenting to the Osteoporosis Re-fracture Prevention service at Westmead Hospital.
Minimum age
55 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria consists of:
1. Severe osteoporosis (BMD T-score of < -3.5);
2. High falls risk, whereby it would be unsafe for the participant to engage in a home exercise program without the direct supervision of a qualified exercise professional;
3. Fracture that seriously limits mobility and movement;
4. Neurological disorder;
5. Neurodegenerative disorder;
6. Secondary osteoporosis; and
7. Patients with recurrent fractures.

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)
Allocation concealment will be maintained using sealed opaque envelopes that are not opened until after the participant is recruited and consented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to the treatment groups will be performed by a computerised randomisation generator, accessed at www.randomization.com, using permuted blocks to maintain balance. Randomisation will be stratified by sex (males/females) and fracture type (e.g. hip, wrist, spine).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 64 patients per randomised group has 80% power to detect a difference in mean 12 month increase from baseline of 0.6% (the difference between an Exercise group mean increase of 7.3% and a Standard group mean increase of 6.7%) assuming that the common standard deviation is 1.2% (independent samples t-test with a 5% two-sided significance level). Assuming 30% of patients may be lost to follow-up, a sample size of 85 per group is required.
The primary analysis of change in absolute BMD will be compared between randomised treatments using two-sample t-tests or Wilcoxon rank sum tests if the data are highly skewed.
Participant demographic and clinical characteristics and study outcomes will be presented using standard descriptive statistics: mean, standard deviation and range or median, quartiles and range for continuous variables; and frequencies and percentages for categorical variables and the Kaplan-Meier method for time-to-event variables.
Analyses will be performed on an intention-to-treat basis, whereby participants are analysed according to their allocated treatment, regardless of treatment actually received.
All study outcomes will be compared between groups using standard statistical methods (analysis of variance (ANOVA) for continuous outcomes, chi-square test for categorical outcomes and log-rank test for time-to-event outcomes) and differences presented with appropriate confidence intervals where possible.
Regression models (linear, logistic and proportional hazards) will be used to explore predictors of outcome. Models describing outcomes over time will take into account potential correlation between repeated observations in the same participant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2021
Actual
Date of last participant enrolment
Anticipated
2/10/2023
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
255
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20080 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 34788 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 309255 0
Charities/Societies/Foundations
Name [1] 309255 0
Westmead Charitable Trust Early Career Researcher Grant
Country [1] 309255 0
Australia
Primary sponsor type
Government body
Name
Western Sydney Local Health District
Address
Cnr Hawkesbury Road and, Darcy Rd, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 310360 0
None
Name [1] 310360 0
Address [1] 310360 0
Country [1] 310360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309100 0
WSLHD Human Research Ethics Committee
Ethics committee address [1] 309100 0
Ethics committee country [1] 309100 0
Australia
Date submitted for ethics approval [1] 309100 0
22/02/2021
Approval date [1] 309100 0
01/04/2021
Ethics approval number [1] 309100 0
2021/PID00344

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112974 0
Dr Christian Girgis
Address 112974 0
Westmead Hospital
Cnr Hawkesbury Road and, Darcy Rd
Westmead NSW 2145
Country 112974 0
Australia
Phone 112974 0
+61 2 8890 4414
Fax 112974 0
Email 112974 0
[email protected]
Contact person for public queries
Name 112975 0
Maree Cassimatis
Address 112975 0
Westmead Hospital
Cnr Hawkesbury Road and, Darcy Rd
Westmead NSW 2145
Country 112975 0
Australia
Phone 112975 0
+61 2 8890 4414
Fax 112975 0
Email 112975 0
[email protected]
Contact person for scientific queries
Name 112976 0
Maree Cassimatis
Address 112976 0
Westmead Hospital
Cnr Hawkesbury Road and, Darcy Rd
Westmead NSW 2145
Country 112976 0
Australia
Phone 112976 0
+61 02 8890 4414
Fax 112976 0
Email 112976 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.