Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000224921p
Ethics application status
Submitted, not yet approved
Date submitted
11/02/2020
Date registered
24/02/2020
Date last updated
24/02/2020
Date data sharing statement initially provided
24/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility, Safety and Efficacy of OsteoStrong® in Postmenopausal Women with Low Bone Mineral Density: A Pilot Study
Scientific title
Feasibility, Safety and Efficacy of OsteoStrong® in Postmenopausal Women with Low Bone Mineral Density: A Pilot Study
Secondary ID [1] 300511 0
None
Universal Trial Number (UTN)
U1111-1248-0714
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 316205 0
Osteopenia 316206 0
Condition category
Condition code
Musculoskeletal 314494 314494 0 0
Osteoporosis
Musculoskeletal 314495 314495 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
OsteoStrong® provides high-intensity progressive resistance training in a supervised setting, which may improve bone health in older adults with poor bone health. This pilot cohort study will investigate the feasibility, safety and efficacy of an 8-month exercise intervention undertaken by OsteoStrong® in postmenopausal women with low bone mineral density. Participants will be provided with a free OsteoStrong® membership for 8 months and will complete supervised, individual training at their preferred OsteoStrong® location (Hawthorn, South Melbourne or Ballarat centre). Exercise prescribed by OsteoStrong® will be individually tailored considering initial fitness, injuries or illness but follow the same procedures.

The intensity and force of the exercise will increase progressively over 8 months, while the frequency and duration of the exercise sessions remain constant at once a week. OsteoStrong® utilises four exercise machines that display the force a participant exerts during each activity. Under the supervision of a trained OsteoStrong® technician, participants will be instructed to engage to their perceived maximum force/loading level on each machine while not reaching a point of discomfort. All four exercises are limited-range static load contractions with minimal change in joint angle. Exertion on each machine will last 8 to 10 seconds. The display screen on each machine will report and record participants' maximum effort. A central database will store the force data for each participant on each machine. The total time for this circuit is four to six minutes, with the total amount of exertion per participant being less than one minute.

To ensure safe transition to this form of progressive resistance training, participants who are deemed deconditioned or have had previous injuries will be instructed to apply only 50% of their maximum effort for the initial session, to be gradually increased over subsequent exercise sessions. All other participants will be encouraged to exert 70-80% of their 1 repetition maximum (1RM) at the first exercise session. At each session, both trainer and participant can view the maximal force achieved for each machine in the previous session. The participant is encouraged to exceed their previous output at each weekly session or minimally achieve 75% of their previous week's force production.
Intervention code [1] 316820 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322822 0
Adherence (attendance at exercise sessions) recorded by OsteoStrong® technicians at every session and self-reported by participants via attendance logs
Timepoint [1] 322822 0
8 months post-intervention commencement
Primary outcome [2] 322823 0
Number of adverse events (pain, injury, falls etc) self-reported by participants during regular follow-up telephone calls
Timepoint [2] 322823 0
8 months post-intervention commencement
Secondary outcome [1] 379898 0
Bone mineral density at hip assessed by dual energy x-ray absorptiometry (DXA)
Timepoint [1] 379898 0
Baseline & 8 months post-intervention commencement
Secondary outcome [2] 379899 0
Bone microarchitecture assessed by high-resolution peripheral quantitative computed tomography (HR-pQCT)
Timepoint [2] 379899 0
Baseline & 8 months post-intervention commencement
Secondary outcome [3] 379900 0
Short Physical Performance Battery (SPPB) test score
Timepoint [3] 379900 0
Baseline & 8 months post-intervention commencement
Secondary outcome [4] 379901 0
Lean mass assessed by dual-energy x-ray absorptiometry (DXA)
Timepoint [4] 379901 0
Baseline & 8 months post-intervention commencement
Secondary outcome [5] 379923 0
Blood serum 25-hydroxyvitamin D (25-OHD)
Timepoint [5] 379923 0
Baseline & 8 months post-intervention commencement
Secondary outcome [6] 379924 0
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Timepoint [6] 379924 0
Baseline & 8 months post-intervention commencement
Secondary outcome [7] 379925 0
Physical activity assessed by accelerometer worn for 7 days
Timepoint [7] 379925 0
Baseline & 8 months post-intervention commencement
Secondary outcome [8] 379926 0
Participants' attitudes (eg. on the benefits and feasibility) of OsteoStrong®, qualitatively assessed via focus groups
Timepoint [8] 379926 0
Baseline & 8 months post-intervention commencement
Secondary outcome [9] 380272 0
Bone mineral density at hip assessed by dual energy x-ray absorptiometry (DXA)
Timepoint [9] 380272 0
Baseline and 8 months post-intervention commencement
Secondary outcome [10] 380273 0
Muscle density assessed by peripheral quantitative computed tomography (pQCT)
Timepoint [10] 380273 0
Baseline and 8 months post-intervention commencement
Secondary outcome [11] 380274 0
Blood serum parathyroid hormone (PTH)
Timepoint [11] 380274 0
Baseline and 8 month post-intervention commencement
Secondary outcome [12] 380275 0
Blood serum estimated glomerular filtration rate (eGFR)
Timepoint [12] 380275 0
Baseline and 8 months post-intervention commencement
Secondary outcome [13] 380276 0
Blood serum type 1 C-telopeptide (CTX)
Timepoint [13] 380276 0
Baseline and 8 months post-intervention commencement
Secondary outcome [14] 380277 0
Blood serum type 1 pro-collagen N-terminal peptides (P1NP)
Timepoint [14] 380277 0
Baseline and 8 months post-intervention commencement
Secondary outcome [15] 380278 0
Centers of Disease Control and Prevention (CDC) Healthy Days Questionnaire score
Timepoint [15] 380278 0
Baseline and 8 months post-intervention commencement
Secondary outcome [16] 380279 0
Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) score
Timepoint [16] 380279 0
Baseline and 8 months post-intervention commencement
Secondary outcome [17] 380280 0
International Physical Activity Questionnaire for the Elderly (IPAQ-E) score
Timepoint [17] 380280 0
Baseline and 8 months post-intervention commencement
Secondary outcome [18] 380281 0
EuroQol-5 Dimensions (EQ-5D) quality of life score
Timepoint [18] 380281 0
Baseline and 8 months post-intervention commencement
Secondary outcome [19] 380282 0
Modified Falls Efficacy Scale score
Timepoint [19] 380282 0
Baseline and 8 months post-intervention commencement
Secondary outcome [20] 380283 0
Hand grip strength assessed by Jamar hydraulic dynamometer
Timepoint [20] 380283 0
Baseline and 8 months post-intervention commencement
Secondary outcome [21] 380284 0
Stair climb power test time
Timepoint [21] 380284 0
Baseline and 8 months post-intervention commencement
Secondary outcome [22] 380285 0
Timed Up and Go (TUG) test time
Timepoint [22] 380285 0
Baseline and 8 months post-intervention commencement
Secondary outcome [23] 380286 0
Leg muscle power assessed by jumping mechanography (Leonardo ground reaction force plate)
Timepoint [23] 380286 0
Baseline and 8 months post-intervention commencement

Eligibility
Key inclusion criteria
- Experienced menopause
- Low bone mineral density (<-1.0 T-score at lumbar spine, non-dominant total hip or femoral neck). Confirmed by DXA scan performed by investigators or self-reported diagnosis in past two years (confirmed by GP)
- Community-dwelling
- GP approval to participate in progressive resistance training
- Body mass index (BMI) <30kg/m2
- <150 minutes of self-reported moderate-vigorous physical activity per week
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Lower- or upper-limb joint injury or surgery in the past 6 months
- Participation in more than or equal to 4 weeks of structured exercise regime in the past 3 months (eg. running program, resistance training)
- Self-reported inability to walk 400 metres, non-stop and unassisted
- Non-English speaking
- Unwilling to travel to Monash Medical Centre for screening, baseline and 8 month assessments
- Expected travel for >1 month over the next 8 months
- Body weight >200kg (upper weight limit for DXA)
- DXA T-score less than or equal -3.0 at any site
- Use of drugs that interfere with bone metabolism in the past 2 years (eg. bisphosphonates, teriparatide, denosumab, hormone replacement therapy, ranitidine, esomeprazole)
- Regular corticosteroid use in the past 3 months
- Self-reported knee or hip osteoarthritis (or other musculoskeletal conditions) causing severe pain during exercise
- Maximum hand grip strength < 16kg determined by hand dynamometry
- Active hernia or recent hernia operation in the past 6 months
- Currently diagnosed conditions known to influence bone health (eg. thyrotoxicosis, current primary hyperparathyroidism, Paget’s disease, eGFR<30 mLs/min, osteogenesis imperfecta, immobility etc)
- Currently diagnosed conditions known to influence calcium or vitamin D intake (eg. Celiac disease, Inflammatory bowel disease)
- Type 1 or 2 Diabetes mellitus
- Diet low in calcium (<1000mg/day) or protein (<0.8g/kg/day) as determined from a short food frequency questionnaire
- Insufficient vitamin D from sun exposure (For individuals with moderately fair skin, <6 minutes daily in December to January with arms exposed, and <25 minutes daily in July to August at midday, with as much bare skin exposed. Individuals with highly pigmented skin would require 3 times the minimum duration.)
- Hypertension (systolic/diastolic blood pressure >140/90) not treated by medication
- High-risk alcohol consumption (more than 14 standard drinks per week)
- Current smoker
- Progressive neurological disorder. (eg. Parkinson’s disease, Alzheimer’s disease, Multiple Sclerosis)
- Lung disease requiring supplemental oxygen
- Myocardial infarction or severe cardiovascular disease
- Any other severe disorder where life expectancy is <12 months
- Any other condition (eg. muscular dystrophy, non-functional limb, paraplegia, quadriplegia) that in the opinion of the investigators may affect a person’s ability to reach minimum osteogenic loading target during test period

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample Size
Although the primary outcomes of interest will be related to feasibility and safety, the sample size calculation is based on a conservative estimate of a 4% improvement in total hip areal BMD (aBMD) following 8 months of OsteoStrong®. This is a clinically significant improvement in aBMD associated with >40% reduction in risk for incident fractures. We will therefore recruit 44 women; adjusting for loss to follow-up of 20%. This sample size is large enough to detect a 4% net difference in total hip aBMD from baseline to 8 months with a type-II error rate of 5% and power of 82%.

Statistical Analysis
At the completion of the study, all data will be entered into a secure Microsoft Access database. Data will be exported to an SPSS file (SPSS Statistics, IBM, USA) and each variable inspected for data errors. In the case of missing or spurious data, original files will be consulted to identify the correct values. When correct values cannot be confirmed, the data point will be classified as missing. Non-normal data will be transformed to meet normality assumptions of parametric methods, or non-parametric methods will be used where appropriate. Paired samples t-tests and Wilcoxon signed rank tests will compare change in outcome measures from baseline to 8 months. For significant associations observed in this preliminary analyses, multivariable regression analyses will be performed to determine whether these associations are independent of potential confounders including age, BMI, co-morbidities and physical activity at baseline. For all analyses, a P-value of <0.05 or 95% confidence interval not including the null point will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2020
Actual
Date of last participant enrolment
Anticipated
31/08/2020
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15839 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 29284 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 304927 0
University
Name [1] 304927 0
Monash University
Country [1] 304927 0
Australia
Funding source category [2] 305020 0
Commercial sector/Industry
Name [2] 305020 0
OsteoStrong Australia Pty Ltd
Country [2] 305020 0
Australia
Primary sponsor type
Individual
Name
David Scott
Address
Rm 7.05 Level 7, MHTP Translational Research Facility
51 Kanooka Grove
Clayton, VIC 3168, Australia
Country
Australia
Secondary sponsor category [1] 305277 0
Commercial sector/Industry
Name [1] 305277 0
OsteoStrong Australia Pty Ltd
Address [1] 305277 0
85 Riversdale Road
Hawthorn VIC 3122
Country [1] 305277 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305334 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 305334 0
Ethics committee country [1] 305334 0
Australia
Date submitted for ethics approval [1] 305334 0
04/11/2019
Approval date [1] 305334 0
Ethics approval number [1] 305334 0

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

Contacts
Principal investigator
Name 100038 0
Dr David Scott
Address 100038 0
Monash Medical Centre
Rm 7.05, Level 7, MHTP Translational Research Facility
51 Kanooka Grove
Clayton, VIC 3168, Australia
Country 100038 0
Australia
Phone 100038 0
+61 3 8572 2397
Fax 100038 0
Email 100038 0
[email protected]
Contact person for public queries
Name 100039 0
David Scott
Address 100039 0
Monash Medical Centre
Rm 7.05, Level 7, MHTP Translational Research Facility
51 Kanooka Grove
Clayton, VIC 3168, Australia
Country 100039 0
Australia
Phone 100039 0
+61 3 8572 2397
Fax 100039 0
Email 100039 0
[email protected]
Contact person for scientific queries
Name 100040 0
David Scott
Address 100040 0
Monash Medical Centre
Rm 7.05, Level 7, MHTP Translational Research Facility
51 Kanooka Grove
Clayton, VIC 3168, Australia
Country 100040 0
Australia
Phone 100040 0
+61 3 8572 2397
Fax 100040 0
Email 100040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months following main results publication, with no end date determined.
Available to whom?
De-identified participant data will be provided on case-by-case basis at the discretion of the Principal Investigator.
Available for what types of analyses?
Any analysis approved by the Principal Investigator after submission of an analysis plan by the applicant.
How or where can data be obtained?
Applications can be made for data access to the Principal Investigator ([email protected]). The data will be transferred to the requesting party via a secure data sharing service.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6855Study protocol  [email protected]
6856Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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