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Trial registered on ANZCTR


Registration number
ACTRN12617001511325
Ethics application status
Approved
Date submitted
3/10/2017
Date registered
27/10/2017
Date last updated
9/01/2020
Date data sharing statement initially provided
31/01/2019
Date results information initially provided
9/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeted exercise to reduce risk of fracture in postmenopausal women with low bone mass who may or may not be on antiresorptive bone medication: The MEDEX-OP trial
Scientific title
Effect of high intensity resistance and impact training on fracture risk in postmenopausal women with low bone mass who may or may not be on antiresorptive bone medication: the MEDEX-OP trial
Secondary ID [1] 293016 0
None
Universal Trial Number (UTN)
Trial acronym
MEDEX-OP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteopenia
304932 0
Osteoporosis 304985 0
Condition category
Condition code
Musculoskeletal 304272 304272 0 0
Osteoporosis
Public Health 304414 304414 0 0
Health service research
Injuries and Accidents 304415 304415 0 0
Fractures
Musculoskeletal 304416 304416 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High intensity progressive resistance and impact loading exercise program (HiRIT)
- Two training sessions of 30-40 minutes per week on non-consecutive days for 8 months
- Group exercise program with a maximum of 8 participants per class and trainer, led by an experienced instructor (the instructor is either an exercise scientist trained in power lifting or an exercise physiologist)
- The program consists of three weight lifting exercises, one impact exercise and two balance exercises that vary each session
- Load and intensity of the lifting and impact exercise will be gradually and individually increased
- Five sets of five repetitions at 80-85% 1RM will be performed for each of the three lifting exercises

- The classes will take place at The Bone Clinic, Coorparoo, Brisbane, QLD
- Adherence will be assessed by the instructor and the study participants. Participants will be given an exercise diary to report the sessions attended, weights lifted, any muscle soreness, injuries, falls and changes in medication. The latter details will also be reported verbally to the investigators.

- 50% of the participants will be on antiresorptive bone medication. Participants will be block randomized based on presence or absence of bone medication intake.


Intervention code [1] 299255 0
Other interventions
Comparator / control treatment
Pilates program
- Two training sessions of 30-40 minutes per week on non-consecutive days for 8 months
- Group exercise program with a maximum of 8 participants per class and trainer, led by an experienced instructor (certified Pilates instructor)
- The program consists of mat-based Pilates exercises.
- Adherence will be assessed by the instructor and the study participants. Participants will be given an exercise diary to report the sessions attended, any muscle soreness, injuries, falls and changes in medication. The latter details will also be reported verbally to the investigators.

- 50% of the participants will be on antiresorptive bone medication. Participants will be block randomized based on presence or absence of bone medication intake.
Control group
Active

Outcomes
Primary outcome [1] 303541 0
Change in areal bone mineral density (aBMD) of the total hip (DXA)
Timepoint [1] 303541 0
8 months
Primary outcome [2] 304654 0
Change in areal bone mineral density (aBMD) of the lumbar spine (DXA)
Timepoint [2] 304654 0
8 months
Secondary outcome [1] 339244 0
BMC at the total hip (DXA)
Timepoint [1] 339244 0
8 months
Secondary outcome [2] 339248 0
aBMD at the femoral neck (DXA)
Timepoint [2] 339248 0
8 months
Secondary outcome [3] 339249 0
BMC at the femoral neck (DXA)
Timepoint [3] 339249 0
8 months
Secondary outcome [4] 339252 0
BMC at the lumbar spine (DXA)
Timepoint [4] 339252 0
8 months
Secondary outcome [5] 339254 0
aBMD at the forearm (DXA)
Timepoint [5] 339254 0
8 months
Secondary outcome [6] 339369 0
BMC at the forearm (DXA)
Timepoint [6] 339369 0
8 months
Secondary outcome [7] 339763 0
Whole body aBMD (DXA)
Timepoint [7] 339763 0
8 months
Secondary outcome [8] 339764 0
Whole body BMC (DXA)
Timepoint [8] 339764 0
8 months
Secondary outcome [9] 339766 0
aBMD at the lateral spine (DXA)
Timepoint [9] 339766 0
8 months
Secondary outcome [10] 339767 0
BMC at the lateral spine (DXA)
Timepoint [10] 339767 0
8 months
Secondary outcome [11] 339773 0
Lean mass (DXA)
Timepoint [11] 339773 0
8 months
Secondary outcome [12] 339776 0
Mobility (Timed Up and Go Test)
Timepoint [12] 339776 0
8 months
Secondary outcome [13] 339777 0
Balance (functional reach test)
Timepoint [13] 339777 0
8 months
Secondary outcome [14] 339778 0
Balance (tandem walk test)
Timepoint [14] 339778 0
8 months
Secondary outcome [15] 339779 0
Back extensor strength (handheld dynamometer)
Timepoint [15] 339779 0
8 months
Secondary outcome [16] 339780 0
Lower extremity strength (five times sit to stand test)
Timepoint [16] 339780 0
8 months
Secondary outcome [17] 339781 0
Leg extensor strength (isometric dynamometer)
Timepoint [17] 339781 0
8 months
Secondary outcome [18] 339782 0
Hand grip strength (handheld dynamometer)
Timepoint [18] 339782 0
8 months
Secondary outcome [19] 339783 0
Gait speed (6 meter walk test)
Timepoint [19] 339783 0
8 months
Secondary outcome [20] 339784 0
Leg muscle peak power (Two leg jump on a Leonardo mechanograph)
Timepoint [20] 339784 0
8 months
Secondary outcome [21] 339785 0
Resting blood pressure (digital blood pressure monitor)
Timepoint [21] 339785 0
8 months
Secondary outcome [22] 339786 0
Posture (Tragus to wall distance measure)
Timepoint [22] 339786 0
8 months
Secondary outcome [23] 339787 0
Posture (relaxed and erect kyphosis measure using an inclinometer)

These are two separate outcomes
Timepoint [23] 339787 0
8 months
Secondary outcome [24] 339788 0
Height in cm
Timepoint [24] 339788 0
8 months
Secondary outcome [25] 339789 0
Waist circumference (tape measure)
Timepoint [25] 339789 0
8 months
Secondary outcome [26] 339790 0
Osteoarthritis pain (WOMAC)
Timepoint [26] 339790 0
8 months
Secondary outcome [27] 339791 0
Rate of falls (fall questionnaire specifically designed for this study to assess circumstances of the fall)
Timepoint [27] 339791 0
8 months
Secondary outcome [28] 339792 0
Quality of life (SF-36 questionnaire)
Timepoint [28] 339792 0
8 months
Secondary outcome [29] 339793 0
Physical activity enjoyment (PACES questionnaire)
Timepoint [29] 339793 0
2, 4, 6 and 8 months
Secondary outcome [30] 339794 0
Pelvic floor health (PFIQ-7 questionnaire)
Timepoint [30] 339794 0
8 months
Secondary outcome [31] 339795 0
Pelvic floor health (PFDI-20 qestionnaire)
Timepoint [31] 339795 0
8 months
Secondary outcome [32] 339858 0
Fat mass (DXA)
Timepoint [32] 339858 0
8 months
Secondary outcome [33] 342697 0
Health care utilisation costs (questionnaire)
Timepoint [33] 342697 0
2, 4, 6 and 8 months
Secondary outcome [34] 342698 0
Hip Bone geometry and volumetric parameters: FN trabecular and cortical volume, trabecular and cortical bone mineral content (BMC), trabecular and cortical volumetric BMD, and FN cortical thickness (DXA hip scans, 3D hip software)
These are multiple separate outcomes and it is not a composite outcome
Timepoint [34] 342698 0
8 months
Secondary outcome [35] 342699 0
Rate of fractures (fracture questionnaire)
Timepoint [35] 342699 0
8 months
Secondary outcome [36] 342700 0
Number of adverse events (questionnaire)
Timepoint [36] 342700 0
8 months
Secondary outcome [37] 342701 0
Adherence: Number of exercise sessions attended (trainer records)
Timepoint [37] 342701 0
8 months

Eligibility
Key inclusion criteria
- Postmenopausal women (>=5 years)
- Low bone mass (BMD > 1 SD below age-matched mean)
- Community ambulant without walking aid
- Good general health
- Taking antiresorptive agents (bisphosphonate or denosumab) for at least 12 months OR not taking bone medication and not intending to change this choice for the study period of 8 months
Minimum age
45 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Lower limb joint injury or surgery
- Recent fracture or acute moderate to severe back pain (previous 6 months)
- Malignancy or currently receiving chemotherapy or radiation therapy
- Cognitive impairment
- Contraindications for participating in heavy physical activity;
- Conditions known to influence bone health (e.g. thyrotoxicosis or hyperparathyroidism, Paget’s disease, renal disease, diabetes, immobility)
- Taking medications known to negatively influence bone health (e.g. prolonged use of corticosteroids, thyroxine, thiazides or antiretroviral agents).
- Medical conditions that would prevent completion of either of the two exercise programs (e.g. uncontrolled cardiovascular disease, nerve disorder, spinal cord injuries)
- Lifestyle choices that prevent adherence to either of the two exercise programs for the intervention duration (e.g. longer than 3 week planned holiday in the next 8 months, etc.)

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 is not concealed but study hypotheses are not disclosed with respects to the expected most efficacious exercise program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation using a randomisation table created by computer software. Stratification variable is medication intake yes/no
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
Sample size determination:
A total of 160 (n=40 in each group) postmenopausal women will be recruited. The sample size calculation was based on the LIFTMOR trial, a previous study which examined the effect of the same HiRIT program on bone health in postmenopausal women.
With a sample size of 160 women we will have 80% power to detect changes in hip BMD and >99% power to detect changes in lumbar spine BMD.
Sample size calculations were conducted using an online calculator (https://www.stat.ubc.ca/~rollin/stats/ssize/n2.html).

Statistical analysis:
Statistical analyses will be performed using SPSS statistical software. In all analyses a p-value of 0.05 (two-sided) will be considered a threshold for statistical significance.
Descriptive analyses will be run for participant characteristics and biometrics. Repeated measures ANCOVA will be conducted to examine treatment effects on all outcome variables adjusting for any variables that differ between groups at baseline. Intention-to-treat analyses will be conducted along with per-protocol analyses to examine specific outcomes of participants completing the full 8 months of training with at least 80% compliance.

Recruitment
Recruitment status
Active, not recruiting
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 in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 17650 0
4151 - Coorparoo
Recruitment postcode(s) [2] 17651 0
4152 - Carindale
Recruitment postcode(s) [3] 17652 0
4120 - Greenslopes
Recruitment postcode(s) [4] 17653 0
4169 - East Brisbane
Recruitment postcode(s) [5] 17654 0
4170 - Morningside
Recruitment postcode(s) [6] 17655 0
4171 - Balmoral
Recruitment postcode(s) [7] 17656 0
4104 - Yeronga
Recruitment postcode(s) [8] 17657 0
4122 - Mount Gravatt
Recruitment postcode(s) [9] 17665 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 297644 0
University
Name [1] 297644 0
Griffith University
Address [1] 297644 0
58 Parklands Dr, Southport QLD 4215
Country [1] 297644 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
58 Parklands Dr, Southport QLD 4215
Country
Australia
Secondary sponsor category [1] 296669 0
None
Name [1] 296669 0
Address [1] 296669 0
Country [1] 296669 0
Other collaborator category [1] 279751 0
Commercial sector/Industry
Name [1] 279751 0
The Bone Clinic
Address [1] 279751 0
26 Turbo Drive
Coorparoo QLD 4151
Country [1] 279751 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298729 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 298729 0
Human Research Ethics Committee
Level 0, Bray Centre (N54)
Griffith University
170 Kessels Road
Nathan Qld 4111
Ethics committee country [1] 298729 0
Australia
Date submitted for ethics approval [1] 298729 0
05/09/2017
Approval date [1] 298729 0
25/09/2017
Ethics approval number [1] 298729 0
2017/739

Summary
Brief summary
Osteoporosis is a condition of greatly increased risk of low trauma fracture. Certain medications and exercises have been shown to increase bone density and decrease fracture risk. The additive effect of those two interventions might yield greater benefits as they have distinct individual effects. While osteoporosis medication has been shown to increase bone mass and reduce fracture, exercise improves bone, muscle and balance thereby reducing falls.
This study will determine the independent and combined effect of exercise and bone medication on bone health in postmenopausal women at risk of osteoporosis. It will also compare the efficacy of two different exercise programs – a resistance and impact training program (HiRIT) and a Pilates exercise program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78042 0
Prof Belinda Beck
Address 78042 0
Menzies Health Institute Queensland
School of Allied Health Sciences
Gold Coast campus, GRIFFITH UNIVERSITY, QLD 4222, Australia
Country 78042 0
Australia
Phone 78042 0
+61 7 5552 8793
Fax 78042 0
+61 7 5552 8674
Email 78042 0
b.beck@griffith.edu.au
Contact person for public queries
Name 78043 0
Miss Melanie Fischbacher
Address 78043 0
Menzies Health Institute Queensland
School of Allied Health Sciences
Gold Coast campus, GRIFFITH UNIVERSITY, QLD 4222, Australia
Country 78043 0
Australia
Phone 78043 0
+61468527219
Fax 78043 0
+61 7 5552 8674
Email 78043 0
melanie.fischbacher@griffithuni.edu.au
Contact person for scientific queries
Name 78044 0
Miss Melanie Fischbacher
Address 78044 0
Menzies Health Institute Queensland
School of Allied Health Sciences
Gold Coast campus, GRIFFITH UNIVERSITY, QLD 4222, Australia
Country 78044 0
Australia
Phone 78044 0
+61468527219
Fax 78044 0
+61 7 5552 8674
Email 78044 0
melanie.fischbacher@griffithuni.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary