ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617001511325

Ethics application status

Approved

Date submitted

3/10/2017

Date registered

27/10/2017

Date last updated

8/04/2021

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]

None

Universal Trial Number (UTN)

Trial acronym

MEDEX-OP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteopenia

Osteoporosis

Condition category

Condition code

Musculoskeletal

Osteoporosis

Public Health

Health service research

Injuries and Accidents

Fractures

Musculoskeletal

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]

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]

Change in areal bone mineral density (aBMD) of the total hip (DXA)

Timepoint [1]

8 months

Primary outcome [2]

Change in areal bone mineral density (aBMD) of the lumbar spine (DXA)

Timepoint [2]

8 months

Secondary outcome [1]

BMC at the total hip (DXA)

Timepoint [1]

8 months

Secondary outcome [2]

aBMD at the femoral neck (DXA)

Timepoint [2]

8 months

Secondary outcome [3]

BMC at the femoral neck (DXA)

Timepoint [3]

8 months

Secondary outcome [4]

BMC at the lumbar spine (DXA)

Timepoint [4]

8 months

Secondary outcome [5]

aBMD at the forearm (DXA)

Timepoint [5]

8 months

Secondary outcome [6]

BMC at the forearm (DXA)

Timepoint [6]

8 months

Secondary outcome [7]

Whole body aBMD (DXA)

Timepoint [7]

8 months

Secondary outcome [8]

Whole body BMC (DXA)

Timepoint [8]

8 months

Secondary outcome [9]

aBMD at the lateral spine (DXA)

Timepoint [9]

8 months

Secondary outcome [10]

BMC at the lateral spine (DXA)

Timepoint [10]

8 months

Secondary outcome [11]

Lean mass (DXA)

Timepoint [11]

8 months

Secondary outcome [12]

Mobility (Timed Up and Go Test)

Timepoint [12]

8 months

Secondary outcome [13]

Balance (functional reach test)

Timepoint [13]

8 months

Secondary outcome [14]

Balance (tandem walk test)

Timepoint [14]

8 months

Secondary outcome [15]

Back extensor strength (handheld dynamometer)

Timepoint [15]

8 months

Secondary outcome [16]

Lower extremity strength (five times sit to stand test)

Timepoint [16]

8 months

Secondary outcome [17]

Leg extensor strength (isometric dynamometer)

Timepoint [17]

8 months

Secondary outcome [18]

Hand grip strength (handheld dynamometer)

Timepoint [18]

8 months

Secondary outcome [19]

Gait speed (6 meter walk test)

Timepoint [19]

8 months

Secondary outcome [20]

Leg muscle peak power (Two leg jump on a Leonardo mechanograph)

Timepoint [20]

8 months

Secondary outcome [21]

Resting blood pressure (digital blood pressure monitor)

Timepoint [21]

8 months

Secondary outcome [22]

Posture (Tragus to wall distance measure)

Timepoint [22]

8 months

Secondary outcome [23]

Posture (relaxed and erect kyphosis measure using an inclinometer)

These are two separate outcomes

Timepoint [23]

8 months

Secondary outcome [24]

Height in cm

Timepoint [24]

8 months

Secondary outcome [25]

Waist circumference (tape measure)

Timepoint [25]

8 months

Secondary outcome [26]

Osteoarthritis pain (WOMAC)

Timepoint [26]

8 months

Secondary outcome [27]

Rate of falls (fall questionnaire specifically designed for this study to assess circumstances of the fall)

Timepoint [27]

8 months

Secondary outcome [28]

Quality of life (SF-36 questionnaire)

Timepoint [28]

8 months

Secondary outcome [29]

Physical activity enjoyment (PACES questionnaire)

Timepoint [29]

2, 4, 6 and 8 months

Secondary outcome [30]

Pelvic floor health (PFIQ-7 questionnaire)

Timepoint [30]

8 months

Secondary outcome [31]

Pelvic floor health (PFDI-20 qestionnaire)

Timepoint [31]

8 months

Secondary outcome [32]

Fat mass (DXA)

Timepoint [32]

8 months

Secondary outcome [33]

Health care utilisation costs (questionnaire)

Timepoint [33]

2, 4, 6 and 8 months

Secondary outcome [34]

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]

8 months

Secondary outcome [35]

Rate of fractures (fracture questionnaire)

Timepoint [35]

8 months

Secondary outcome [36]

Number of adverse events (questionnaire)

Timepoint [36]

8 months

Secondary outcome [37]

Adherence: Number of exercise sessions attended (trainer records)

Timepoint [37]

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

Sex

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

Completed

Date of first participant enrolment

Anticipated

19/02/2018

Actual

19/03/2018

Date of last participant enrolment

Anticipated

26/04/2019

Actual

29/11/2019

Date of last data collection

Anticipated

29/08/2020

Actual

10/08/2020

Sample size

Target

160

Accrual to date

Final

116

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4151 - Coorparoo

Recruitment postcode(s) [2]

4152 - Carindale

Recruitment postcode(s) [3]

4120 - Greenslopes

Recruitment postcode(s) [4]

4169 - East Brisbane

Recruitment postcode(s) [5]

4170 - Morningside

Recruitment postcode(s) [6]

4171 - Balmoral

Recruitment postcode(s) [7]

4104 - Yeronga

Recruitment postcode(s) [8]

4122 - Mount Gravatt

Recruitment postcode(s) [9]

4000 - Brisbane

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith University

Address [1]

58 Parklands Dr, Southport QLD 4215

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

58 Parklands Dr, Southport QLD 4215

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

The Bone Clinic

Address [1]

26 Turbo Drive
Coorparoo QLD 4151

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee
Level 0, Bray Centre (N54)
Griffith University
170 Kessels Road
Nathan Qld 4111

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/09/2017

Approval date [1]

25/09/2017

Ethics approval number [1]

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

Prof Belinda Beck

Address

Menzies Health Institute Queensland
School of Allied Health Sciences
Gold Coast campus, GRIFFITH UNIVERSITY, QLD 4222, Australia

Country

Australia

Phone

+61 7 5552 8793

Fax

+61 7 5552 8674

[email protected]

Contact person for public queries

Name

Miss Melanie Fischbacher

Address

Menzies Health Institute Queensland
School of Allied Health Sciences
Gold Coast campus, GRIFFITH UNIVERSITY, QLD 4222, Australia

Country

Australia

Phone

+61459355590

Fax

+61 7 5552 8674

[email protected]

Contact person for scientific queries

Name

Miss Melanie Fischbacher

Address

Menzies Health Institute Queensland
School of Allied Health Sciences
Gold Coast campus, GRIFFITH UNIVERSITY, QLD 4222, Australia

Country

Australia

Phone

+61468527219

Fax

+61 7 5552 8674

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11306	Ethical approval			[email protected]
11307	Informed consent form			[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The influence of antiresorptive bone medication on the effect of high-intensity resistance and impact training on osteoporotic fracture risk in postmenopausal women with low bone mass: Protocol for the MEDEX-OP randomised controlled trial.	2019	https://dx.doi.org/10.1136/bmjopen-2019-029895
Embase	A Comparison of Bone-Targeted Exercise With and Without Antiresorptive Bone Medication to Reduce Indices of Fracture Risk in Postmenopausal Women With Low Bone Mass: The MEDEX-OP Randomized Controlled Trial.	2021	https://dx.doi.org/10.1002/jbmr.4334
Embase	High-Intensity Exercise and Geometric Indices of Hip Bone Strength in Postmenopausal Women on or off Bone Medication: The MEDEX-OP Randomised Controlled Trial.	2022	https://dx.doi.org/10.1007/s00223-022-00991-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically