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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001511325
Acronym
MEDEX-OP
Enrollment
116
Registered
2017-10-27
Start date
2018-03-19
Completion date
2019-11-29
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Griffith University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
Yes

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

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.)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 20, 2026